A Study to Test Whether Different Doses of BI 690517 Alon... | NCT05182840 | Trialant
NCT05182840
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Oct 22, 2024Actual
Enrollment
714Actual
Phase
Phase 2
Conditions
Kidney Disease, Chronic
Interventions
BI 690517
Placebo to BI 690517
Empagliflozin
Placebo to empagliflozin
Countries
United States
Argentina
Australia
Belgium
Brazil
Bulgaria
Canada
China
Czechia
Finland
Germany
Greece
Hong Kong
Hungary
India
Italy
Japan
Malaysia
Mexico
Norway
Philippines
Poland
Portugal
South Africa
South Korea
Spain
Sweden
Switzerland
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
NCT05182840
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1378.5
Secondary IDs
ID
Type
Description
Link
2021-001434-19
EudraCT Number
1378-0005
Other Identifier
Boehringer Ingelheim
Brief Title
A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease
Official Title
Randomised, Double-blind, Placebo-controlled and Parallel Dose Group Trial to Investigate Efficacy and Safety of Multiple Doses of Oral BI 690517 Over 14 Weeks, Alone and in Combination With Empagliflozin, in Patients With Diabetic and Non-diabetic Chronic Kidney Disease
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Oct 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 11, 2022Actual
Primary Completion Date
Jun 19, 2023Actual
Completion Date
Jul 10, 2023Actual
First Submitted Date
Jan 5, 2022
First Submission Date that Met QC Criteria
Jan 5, 2022
First Posted Date
Jan 10, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Jun 18, 2024
Results First Submitted that Met QC Criteria
Aug 5, 2024
Results First Posted Date
Aug 29, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 9, 2024
Last Update Posted Date
Oct 22, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is open to adults with chronic kidney disease. People with and without type 2 diabetes can take part in this study.
The purpose of this study is to find out whether a medicine called BI 690517 improves kidney function in people with chronic kidney disease when taken alone or in combination with a medicine called empagliflozin.
In the first part of the study, participants take empagliflozin or placebo as tablets every day for 2 months. Placebo tablets look like empagliflozin tablets but do not contain any medicine.
In the second part, participants are divided into several groups. Depending on the group, the participants then additionally take different doses of BI 690517 or placebo as tablets for 3.5 months. In this case, placebo tablets look like BI 690517 tablets but do not contain any medicine.
Participants are in the study for about 6 months. During this time, they visit the study site about 12 times. Where possible, about 4 of the 12 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call.
Participants collect urine samples at home. These samples are then analysed to assess kidney function. At the end of the trial the results are compared between the different groups. The doctors also regularly check participants' health and take note of any unwanted effects.
Detailed Description
Not provided
Conditions Module
Conditions
Kidney Disease, Chronic
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
714Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Run-in period: 10 mg empagliflozin
Experimental
Drug: Empagliflozin
Run-in period: Placebo to empagliflozin 10 mg
Placebo Comparator
Drug: Placebo to empagliflozin
Treatment period: 10 mg empagliflozin + 3 mg BI 690517
Experimental
Drug: BI 690517
Drug: Empagliflozin
Treatment period: 10 mg empagliflozin + 10 mg BI 690517
Experimental
Drug: BI 690517
Drug: Empagliflozin
Treatment period: 10 mg empagliflozin + 20 mg BI 690517
Experimental
Drug: BI 690517
Drug: Empagliflozin
Treatment period: 10 mg empagliflozin + Placebo to BI 690517
Placebo Comparator
Drug: Placebo to BI 690517
Drug: Empagliflozin
Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BI 690517
Drug
Film-coated tablets
Treatment period: 10 mg empagliflozin + 10 mg BI 690517
Treatment period: 10 mg empagliflozin + 20 mg BI 690517
Treatment period: 10 mg empagliflozin + 3 mg BI 690517
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Treatment Period Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void (FMV) Urine After 14 Weeks - All Patients
The adjusted mean change (95% confidence interval) in log transformed FMV UACR from baseline at 14 weeks is presented.
The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - All Patients
Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for all patients is presented.
Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)*100/(FMV UACR at baseline).
MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Placebo Matching Empagliflozin
The adjusted mean change (95% confidence interval) in log transformed first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline at 14 weeks for patients with background therapy of placebo matching empagliflozin in the Run-in period is presented.
The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
Secondary Outcomes
Measure
Description
Time Frame
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Multiple Imputation
Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria
Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
Male or female patients of legal adult age (according to local legislation) and aged ≥ 18 years at time of consent.
estimated Glomerular Filtration Rate (eGFR, Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥ 30 and < 90 mL/min/1.73 m2 at Visit 1 by central laboratory analysis.
Urine Albumin Creatinine Ratio (UACR) ≥ 200 and < 5,000 mg/g in spot urine (midstream urine sample) by central laboratory analysis at Visit 1.1
If the patient is taking any of the following medications they should be on a stable dose for at least 4 weeks prior to visit 1 and until first randomisation prior to run-in with no planned change of the therapy during the trial: anti-hypertensives, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), endothelin receptor antagonists, low dose systemic steroids (e.g. prednisolone ≤10 mg or equivalent).
Treatment with a clinically appropriate, stable dose of either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) (but not both together), for ≥ 4 weeks prior to visit 1 and until first randomisation with no planned change of the therapy during the trial.
In the Investigator's opinion, any kind of diagnosed chronic kidney disease (Diagnosis can be reached by standard clinical method, no biopsy required). Patients with diabetic kidney disease must have type 2 diabetes mellitus and their treatment (including GLP1 receptor agonist) should be unchanged or changes deemed minor (according to investigator's judgement) within 4 weeks prior to Visit 1 and until first randomisation.
Glycated Haemoglobin (HbA1c) < 10.0% at Visit 1 measured by the central laboratory.
Serum potassium ≤ 4.8 mmol/L at Visit 1 measured by the central laboratory.
Seated Systolic Blood Pressure (SBP) ≥ 110 and ≤ 160 mmHg and Diastolic Blood Pressure (DBP) ≥ 65 and ≤ 110 mmHg at Visit 1 (mean values from three Blood Pressure (BP) measurements) and optimised anti-hypertensive treatment according to local standard of care and investigator's judgement.
Body Mass Index (BMI) ≥ 18.5 and < 50 kg/m2 at Visit 1.
Women of child-bearing potential2 (WOCBP) must be ready and able to use highly effective methods of birth control. Such methods should be used throughout the trial. Men must be vasectomised or willing and able to use a condom if their partner is a WOCBP.
Additional inclusion criteria to be assessed before second randomisation (start of Treatment Period):
Serum potassium ≤ 4.8 mmol/L measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.
eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥ 20 mL/min/1.73 m2 measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.
Exclusion criteria
Treatment with inhibitors of aldosterone mediated effects (e.g., mineralocorticoid receptor antagonists such as spironolactone), or intake of other potassium sparing diuretics (e.g., amiloride) within 7 days prior to first randomisation or planned during trial treatment phase.
Treatment with other Renin Angiotensin Aldosterone System (RAAS) interventions (apart from either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)) within 4 weeks prior to Visit 1 and throughout screening or planned during the trial. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial are also excluded.
Type 1 diabetes mellitus, or history of other autoimmune causes of diabetes mellitus (e.g. Latent Autoimmune Diabetes (LADA))
Patients at increased risk of ketoacidosis in the opinion of the investigator.
Currently receiving Sodium-glucose cotransporter (SGLT)-2 or SGLT-1/2 inhibitor or planned initiation during the trial.
Cherney DZI, Rossing P, Canziani ME, Caramori ML, Correa-Rotter R, Cronin L, Hugo C, Ji B, Meyerhoff J, Nangaku M, Silva A, Urbach D, Shah SV, de Zeeuw D, Tuttle KR. Effects of Vicadrostat/Empagliflozin in People With Chronic Kidney Disease: Metabolic Subgroup Analyses. Diabetes Obes Metab. 2026 Jul;28(7):6324-6333. doi: 10.1111/dom.70836. Epub 2026 May 5.
Once the time frame criteria given under number 4 are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
2 patients of the arm "Run-in period: Placebo to empagliflozin 10 mg" who did not complete the Run-in period (RP) were mistakenly randomized to the treatment period (TP) but were not treated during the TP with BI 690517 or placebo to BI 690517.
Recruitment Details
The trial included two randomisations, R1 and R2. At first randomisation R1, patients were 1:1 randomised to a run-in period of 8 weeks and received 10 mg empagliflozin or placebo matching empagliflozin. The run-in period was followed by randomisation R2 at which patients were 1:1:1:1 randomized to a treatment period of 14 weeks to receive one of three doses of BI 690517 or placebo matching BI 690517 in combination with the background medication assigned in the randomized run-in period.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Run-in Period: 10 mg Empagliflozin
Patients received during the run-in period 10 milligrams (mg) of empagliflozin once daily orally for 8 weeks.
Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517
Experimental
Drug: BI 690517
Drug: Placebo to empagliflozin
Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517
Experimental
Drug: BI 690517
Drug: Placebo to empagliflozin
Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517
Placebo Comparator
Drug: Placebo to BI 690517
Drug: Placebo to empagliflozin
Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517
Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517
Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517
Vicadrostat
Placebo to BI 690517
Drug
Film-coated tablets
Treatment period: 10 mg empagliflozin + Placebo to BI 690517
Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517
Empagliflozin
Drug
Empagliflozin
Run-in period: 10 mg empagliflozin
Treatment period: 10 mg empagliflozin + 10 mg BI 690517
Treatment period: 10 mg empagliflozin + 20 mg BI 690517
Treatment period: 10 mg empagliflozin + 3 mg BI 690517
Treatment period: 10 mg empagliflozin + Placebo to BI 690517
Placebo to empagliflozin
Drug
Placebo to empagliflozin
Run-in period: Placebo to empagliflozin 10 mg
Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517
Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517
Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517
Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - Patients With Background Therapy of Placebo Matching Empagliflozin
Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for patients with background therapy of placebo matching empagliflozin in the Run-in period is presented.
Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)*100/(FMV UACR at baseline).
MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Empagliflozin
The adjusted mean change (95% confidence interval) in log transformed first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline at 14 weeks for patients with background therapy of empagliflozin in the Run-in period is presented.
The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) of MMRM Estimate - Patients With Background Therapy of Empagliflozin
Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for patients with background therapy of empagliflozin in the Run-in period is presented.
Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)*100/(FMV UACR at baseline).
MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder
Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The missing as non-responder imputes patients with missing Week 14 data as non-responders.
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Week - All Patients - Last Observation on Treatment Carried Forward (LOCF)
Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis
Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
Complete case analysis used patients with both baseline and Week 14 data available.
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation
Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder
Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The missing as non-responder imputes patients with missing Week 14 data as non-responders.
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF)
Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void (FMV) urine of UACR from treatment period baseline to 14 weeks.
LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis
Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
Complete case analysis used patients with both baseline and Week 14 data available.
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation
Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder
Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The missing as non-responder imputes patients with missing Week 14 data as non-responders.
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward
Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
Last observation on treatment carried forward (LOCF) uses the last value observed on treatment to substitute all missing values until Week 14.
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis
Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
Complete case analysis used patients with both baseline and Week 14 data available.
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients -Multiple Imputation
Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 week. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder
Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The missing as non-responder imputes patients with missing Week 14 data as non-responders.
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Last Observation on Treatment Carried Forward (LOCF)
Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis
Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
Complete case analysis used patients with both baseline and Week 14 data available.
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation
Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder
Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The missing as non-responder imputes patients with missing Week 14 data as non-responders.
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF)
Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void (FMV) urine of UACR from treatment period baseline to 14 weeks.
LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation
Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder
Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The missing as non-responder imputes patients with missing Week 14 data as non-responders.
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward
Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
Last observation on treatment carried forward (LOCF) uses the last value observed on treatment to substitute all missing values until Week 14.
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks -Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis
Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
Complete case analysis used patients with both baseline and Week 14 data available.
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis
Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
Complete case analysis used patients with both baseline and Week 14 data available.
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Phoenix
Arizona
85027
United States
Clearview Medical Research, LLC
Canyon Country
California
91351
United States
Pacific Renal Associates
Long Beach
California
90806
United States
Amicis Research Center
Northridge
California
91324
United States
Valley Clinical Trials, Inc.
Northridge
California
91325
United States
California Kidney Specialists
San Dimas
California
91773
United States
Colorado Kidney Care
Denver
Colorado
80230
United States
Clinical Research of Brandon LLC
Brandon
Florida
33511
United States
Horizon Research Group
Coral Gables
Florida
33134
United States
Elixia Fort Lauderdale, LLC
Fort Lauderdale
Florida
33308
United States
South Florida Research Institute
Lauderdale Lakes
Florida
33313
United States
San Marcus Research Clinic, Inc.
Miami
Florida
33014
United States
Total Research Group, LLC
Miami
Florida
33126
United States
Horizon Research Group, LLC
Miami
Florida
33150
United States
West Orange Endocrinology
Ocoee
Florida
34761
United States
Pines Care Research Center
Pembroke Pines
Florida
33024
United States
Elixia Tampa, LLC
Temple Terrace
Florida
33637
United States
Boise Kidney and Hypertension PLLC
Nampa
Idaho
83687
United States
Cedar Crosse Research Center
Chicago
Illinois
60607
United States
Kansas Nephrology Research Institute, LLC
Wichita
Kansas
67214
United States
Aa Mrc Llc
Flint
Michigan
48504
United States
Elite Research Center, LLC
Flint
Michigan
48532
United States
Clinical Research Consultants, LLC
Kansas City
Missouri
64111
United States
Forte Family Practice
Las Vegas
Nevada
89103
United States
New Mexico Clinical Research and Osteoporosis Center, Inc.
Albuquerque
New Mexico
87106
United States
Triad Internal Medicine
Asheboro
North Carolina
27203
United States
Lucas Research, Inc.
Morehead City
North Carolina
28557
United States
Diabetes & Endocrinology Associates of Stark County
Gashaw IA, Tuttle KR, Monroy Kuhn M, Pleiner S, Delic D, Cronin L, Shah SV, Rossing P. Pharmacodynamics of vicadrostat for aldosterone synthase inhibition in patients with CKD. Eur J Endocrinol. 2026 Jan 6;194(1):46-57. doi: 10.1093/ejendo/lvaf265.
Tuttle KR, Hauske SJ, Canziani ME, Caramori ML, Cherney D, Cronin L, Heerspink HJL, Hugo C, Nangaku M, Rotter RC, Silva A, Shah SV, Sun Z, Urbach D, de Zeeuw D, Rossing P; ASi in CKD group. Efficacy and safety of aldosterone synthase inhibition with and without empagliflozin for chronic kidney disease: a randomised, controlled, phase 2 trial. Lancet. 2024 Jan 27;403(10424):379-390. doi: 10.1016/S0140-6736(23)02408-X. Epub 2023 Dec 15.
Tuttle KR, Rossing P, Hauske SJ, Cronin L, Hussain J, de Zeeuw D, Heerspink HJL. Methods Article for a Study Protocol: Study Design and Baseline Characteristics for Aldosterone Synthase Inhibition in Chronic Kidney Disease. Am J Nephrol. 2024;55(2):262-272. doi: 10.1159/000534808. Epub 2023 Oct 30.
Patients received during the run-in period placebo matching empagliflozin 10 milligrams (mg) once daily orally for 8 weeks.
FG002
Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
FG003
Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
FG004
Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
FG005
Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.
FG006
Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
FG007
Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
FG008
Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
FG009
Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
FG000356 subjects
FG001358 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Treated With Empagliflozin 10 mg or Placebo Matching Empagliflozin 10 mg
FG000356 subjects
FG001357 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG000332 subjects
FG001330 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG00024 subjects
FG00128 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Not treated
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Other reason but not sponsor termination
FG00014 subjects
FG00118 subjects
FG0020 subjects
FG0030 subjects
FG004
No reason available
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Burden of study procedures
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Change of residence
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0005 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG004
Completed RP and Randomized to TP
Type
Comment
Milestone Data
STARTED
Completed planned Run-in period
FG000332 subjects
FG001330 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
Randomised to Treatment period
FG000298 subjects
FG001286 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG00034 subjects
FG00144 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Did not meet additional inclusion/exclusion criteria for Treatment Period
FG00034 subjects
FG00144 subjects
FG0020 subjects
FG003
Patients Starting the Treatment Period
Type
Comment
Milestone Data
STARTED
FG000298 subjects
FG001288 subjects2 participants of this arm who did not complete the Run-in period were randomized mistakenly to the Treatment Period. Therefore 2 milestones below were added.
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Did Not Complete the run-in Period and Was Randomized to Treatment Period
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
Completed run-in Period and Randomized to Treatment Period
FG000298 subjects
FG001286 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG000298 subjects
FG001288 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Treatment Period
Type
Comment
Milestone Data
STARTED
Randomised to Treatment period
FG0000 subjectsPatients who received empagliflozin in the Run-in Period and met the eligibility criteria to enter the Treatment Period were randomised equally into one of four parallel dose groups in a 1:1:1:1 ratio to receive one of 3 doses of BI 690517 (3 mg QD, 10 mg QD or 20 mg QD) in combination with empagliflozin, or empagliflozin alone (empagliflozin plus placebo matching to BI 690517).
FG0010 subjectsPatients who received placebo in the Run-in Period were randomised equally into one of four parallel dose groups in a 1:1:1:1 ratio to receive one of 3 doses of BI 690517 (3 mg QD, 10 mg QD or 20 mg QD) or placebo (placebo to empagliflozin placebo matching to BI 690517).
FG00276 subjects
FG00374 subjects
FG00474 subjects
FG00574 subjects
FG00671 subjects
FG00772 subjects
FG00872 subjects
FG00973 subjects
Treated With BI 690517 or Placebo Matching BI 690517
FG0000 subjects
FG0010 subjects
FG00276 subjects
FG00373 subjects
COMPLETED
Completed planned treatment with BI 690517 or placebo matching BI 690517
FG0000 subjects
FG0010 subjects
FG00263 subjects
FG003
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00213 subjects
FG00324 subjects
FG004
Type
Comment
Reasons
Reason missing
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Randomised Set (RS): This patient set included all entered and randomised patients based on the treatment groups they were randomised to at the randomisation prior to the treatment period (i.e. at second randomisation (R2)), regardless of being treated by BI 690517 or not.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
BG001
Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
BG002
Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
BG003
Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.
BG004
Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
BG005
Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
BG006
Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
BG007
Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00076
BG00174
BG00274
BG00374
BG00471
BG00572
BG00672
BG00773
BG008586
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
ParticipantsBG00076
ParticipantsBG00174
ParticipantsBG00274
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00076
ParticipantsBG00174
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00076
ParticipantsBG00174
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00076
ParticipantsBG00174
ParticipantsBG002
Urine Albumin Creatinine Ratio (UACR) at baseline
UACR is a ratio between two measured substances i.e., albumine and creatinine and it is calculated as: (Urine albumin (milligram (mg)/deciliter (dL)))/(urine creatinine gram (g)/deciliter (dL))= UACR in mg/g.
Albuminuria is present when UACR is greater than 30 mg/g and is a marker for chronic kidney disease (CKD).
UACR measurements were collected on 2 consecutive days at 3 timepoints from Week -2 to Week 0 (i.e. Week 6-8 of Run-in period) for treatment period baseline.
Randomised Set (RS): This patient set included all entered and randomised patients based on the treatment groups they were randomised to at the randomisation prior to the treatment period (i.e. at second randomisation (R2)), regardless of being treated by BI 690517 or not.
Three patients in the RS had missing baseline values for UACR.
Mean
Standard Deviation
milligram/gram
Title
Denominators
Categories
ParticipantsBG00076
ParticipantsBG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Treatment Period Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void (FMV) Urine After 14 Weeks - All Patients
The adjusted mean change (95% confidence interval) in log transformed FMV UACR from baseline at 14 weeks is presented.
The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
Posted
Least Squares Mean
95% Confidence Interval
log (milligram/gram)
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
ID
Title
Description
OG000
3 mg BI 690517
This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).
OG001
10 mg BI 690517
This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).
OG002
20 mg BI 690517
This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).
OG003
Placebo to BI 690517
This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
Units
Counts
Participants
OG000128
OG001121
OG002121
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.235(-0.355 to -0.114)
OG001-0.553(-0.681 to -0.425)
OG002-0.487(-0.616 to -0.357)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
MMRM
0.0499
Mean Difference (Net)
-0.168
2-Sided
95
-0.337
-0.000
Least Squares Mean of "3 mg BI 690517" - Least Squares Mean of "Placebo to BI 690517".
Primary
Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - All Patients
Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for all patients is presented.
Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)*100/(FMV UACR at baseline).
MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
Posted
Median
95% Confidence Interval
percent change of FMV UACR
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
ID
Title
Description
OG000
3 mg BI 690517
This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).
Primary
Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Placebo Matching Empagliflozin
The adjusted mean change (95% confidence interval) in log transformed first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline at 14 weeks for patients with background therapy of placebo matching empagliflozin in the Run-in period is presented.
The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
All randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
Posted
Least Squares Mean
95% Confidence Interval
log (milligram/gram)
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
ID
Title
Description
OG000
Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Primary
Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - Patients With Background Therapy of Placebo Matching Empagliflozin
Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for patients with background therapy of placebo matching empagliflozin in the Run-in period is presented.
Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)*100/(FMV UACR at baseline).
MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
All randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
Posted
Median
95% Confidence Interval
percent change of FMV UACR
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
ID
Title
Description
OG000
Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Primary
Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Empagliflozin
The adjusted mean change (95% confidence interval) in log transformed first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline at 14 weeks for patients with background therapy of empagliflozin in the Run-in period is presented.
The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
All randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
Posted
Least Squares Mean
95% Confidence Interval
log (milligram/gram)
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
ID
Title
Description
OG000
Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
Primary
Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) of MMRM Estimate - Patients With Background Therapy of Empagliflozin
Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for patients with background therapy of empagliflozin in the Run-in period is presented.
Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)*100/(FMV UACR at baseline).
MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
All randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
Posted
Median
95% Confidence Interval
percent change of FMV UACR
The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
ID
Title
Description
OG000
Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Multiple Imputation
Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
Full Analysis Set (FAS): This patient set included all randomised patients who had at least one baseline measurement of UACR at Week -2, -1, or 0 and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
Posted
Count of Participants
Participants
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
ID
Title
Description
OG000
3 mg BI 690517
This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant flow).
OG001
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder
Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The missing as non-responder imputes patients with missing Week 14 data as non-responders.
Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
The missing as non-responder imputes patients with missing Week 14 data as non-responders.
Posted
Count of Participants
Participants
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
ID
Title
Description
OG000
3 mg BI 690517
This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant flow).
OG001
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Week - All Patients - Last Observation on Treatment Carried Forward (LOCF)
Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
Posted
Count of Participants
Participants
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
ID
Title
Description
OG000
BI 690517 3 mg
This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant flow).
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis
Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
Complete case analysis used patients with both baseline and Week 14 data available.
All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (i.e. Week 6, 7 or 8 of Run-in period) and one post-baseline measurement at Week 12-14 when patients were still on treatment with BI 690517 or placebo matching BI 690517.
Posted
Count of Participants
Participants
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
ID
Title
Description
OG000
3 mg BI 690517
This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).
OG001
10 mg BI 690517
This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation
Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
All randomised patients to one of 3 doses of BI 690517 or placebo to BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo to BI 690517. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
Posted
Count of Participants
Participants
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
ID
Title
Description
OG000
Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder
Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The missing as non-responder imputes patients with missing Week 14 data as non-responders.
All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The missing as non-responder imputes patients with missing Week 14 data as non-responders.
Posted
Count of Participants
Participants
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
ID
Title
Description
OG000
Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF)
Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void (FMV) urine of UACR from treatment period baseline to 14 weeks.
LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
Posted
Count of Participants
Participants
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
ID
Title
Description
OG000
Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis
Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
Complete case analysis used patients with both baseline and Week 14 data available.
All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had received placebo matching empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (i.e. Week 6, 7 or 8 of Run-in period) and one post-baseline measurement at Week 12-14 when patients were still on treatment with BI 690517 or placebo matching BI 690517.
Posted
Count of Participants
Participants
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
ID
Title
Description
OG000
Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation
Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
All randomised patients to of 3 doses of BI 690517 or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
Posted
Count of Participants
Participants
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
ID
Title
Description
OG000
Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder
Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The missing as non-responder imputes patients with missing Week 14 data as non-responders.
All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The missing as non-responder imputes patients with missing Week 14 data as non-responders.
Posted
Count of Participants
Participants
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
ID
Title
Description
OG000
Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward
Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
Last observation on treatment carried forward (LOCF) uses the last value observed on treatment to substitute all missing values until Week 14.
All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
Posted
Count of Participants
Participants
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
ID
Title
Description
OG000
Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis
Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
Complete case analysis used patients with both baseline and Week 14 data available.
All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (i.e. Week 6, 7 or 8 of Run-in period) and one post-baseline measurement at Week 12-14 when patients were still on treatment with BI 690517 or placebo matching BI 690517.
Posted
Count of Participants
Participants
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
ID
Title
Description
OG000
Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG001
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients -Multiple Imputation
Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 week. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
Posted
Count of Participants
Participants
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
ID
Title
Description
OG000
3 mg BI 690517
This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder
Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The missing as non-responder imputes patients with missing Week 14 data as non-responders.
Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
The missing as non-responder imputes patients with missing Week 14 data as non-responders.
Posted
Count of Participants
Participants
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
ID
Title
Description
OG000
3 mg BI 690517
This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).
OG001
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Last Observation on Treatment Carried Forward (LOCF)
Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
Posted
Count of Participants
Participants
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
ID
Title
Description
OG000
3 mg BI 690517
This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis
Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
Complete case analysis used patients with both baseline and Week 14 data available.
All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (i.e. Week 6, 7 or 8 of Run-in period) and one post-baseline measurement at Week 12-14 when patients were still on treatment with BI 690517 or placebo matching BI 690517.
Posted
Count of Participants
Participants
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
ID
Title
Description
OG000
3 mg BI 690517
This arm includes patients who received during the Treatment Period 3 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 3 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" in the Participant Flow).
OG001
10 mg BI 690517
This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation
Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
All randomised patients to one of 3 doses of BI 690517 or placebo to BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo to BI 690517. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
Posted
Count of Participants
Participants
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
ID
Title
Description
OG000
Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder
Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The missing as non-responder imputes patients with missing Week 14 data as non-responders.
All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The missing as non-responder imputes patients with missing Week 14 data as non-responders.
Posted
Count of Participants
Participants
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
ID
Title
Description
OG000
Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF)
Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void (FMV) urine of UACR from treatment period baseline to 14 weeks.
LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
Posted
Count of Participants
Participants
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
ID
Title
Description
OG000
Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation
Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
Posted
Count of Participants
Participants
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
ID
Title
Description
OG000
Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder
Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
The missing as non-responder imputes patients with missing Week 14 data as non-responders.
All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The missing as non-responder imputes patients with missing Week 14 data as non-responders.
Posted
Count of Participants
Participants
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
ID
Title
Description
OG000
Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward
Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
Last observation on treatment carried forward (LOCF) uses the last value observed on treatment to substitute all missing values until Week 14.
All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
Posted
Count of Participants
Participants
UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
ID
Title
Description
OG000
Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks -Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis
Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
Complete case analysis used patients with both baseline and Week 14 data available.
All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had received placebo matching empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (i.e. Week 6, 7 or 8 of Run-in period) and one post-baseline measurement at Week 12-14 when patients were still on treatment with BI 690517 or placebo matching BI 690517.
Posted
Count of Participants
Participants
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
ID
Title
Description
OG000
Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis
Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.
Complete case analysis used patients with both baseline and Week 14 data available.
All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (i.e. Week 6, 7 or 8 of Run-in period) and one post-baseline measurement at Week 12-14 when patients were still on treatment with BI 690517 or placebo matching BI 690517.
Posted
Count of Participants
Participants
At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
ID
Title
Description
OG000
Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG001
Time Frame
Run-in period: From first study drug administration in the run-in period until end of the residual effect period (REP) (i.e., 7 days), up to 9 weeks. Treatment period: From first study drug administration in the treatment period until end of REP (i.e. 7 days), up to 15 weeks. All-Cause Mortality for treatment period: From study drug administration in the treatment period until end of the follow-up period, up to 18 weeks. Continues in the description.
Description
Patients with treatment-emergent adverse events starting during overlapping run-in residual effect period and treatment period are counted in both the run-in period and treatment period.
Run-in treated set: All randomised patients of the Run-in Period who were documented to have taken at least one dose of empagliflozin or placebo.
Treated set: All patients who received at least one dose of BI 690517 or placebo matching BI 690517.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Run-in Period: 10 mg Empagliflozin
Patients received during the run-in period 10 milligrams (mg) of empagliflozin once daily orally for 8 weeks.
0
356
9
356
17
356
EG001
Run-in Period: Placebo to Empagliflozin 10 mg
Patients received during the run-in period placebo matching empagliflozin 10 milligrams (mg) once daily orally for 8 weeks.
2
357
20
357
15
357
EG002
Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
1
76
4
76
11
76
EG003
Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
1
73
7
73
20
73
EG004
Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
0
74
5
74
19
74
EG005
Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.
2
74
7
74
13
74
EG006
Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
0
70
3
70
15
70
EG007
Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
1
71
4
71
16
71
EG008
Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
1
72
6
72
25
72
EG009
Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
0
73
3
73
9
73
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Sudden death
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG0030 affected73 at risk
EG0040 affected74 at risk
EG0051 affected74 at risk
EG0060 affected70 at risk
EG0071 affected71 at risk
EG0080 affected72 at risk
EG0090 affected73 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0012 affected357 at risk
EG0020 affected76 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected356 at risk
EG0012 affected357 at risk
EG0021 affected76 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Hypertensive heart disease
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Intracardiac thrombus
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Glucocorticoid deficiency
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0021 affected76 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Thrombosis mesenteric vessel
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Abscess soft tissue
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Dengue fever
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0021 affected76 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 affected356 at risk
EG0011 affected357 at risk
EG0021 affected76 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Haematuria traumatic
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected356 at risk
EG0012 affected357 at risk
EG0020 affected76 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Metabolic syndrome
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0021 affected76 at risk
EG003
Squamous cell carcinoma of lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Transitional cell carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Ischaemic cerebral infarction
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Syncope
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected356 at risk
EG0012 affected357 at risk
EG0020 affected76 at risk
EG003
Focal segmental glomerulosclerosis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Haemorrhage urinary tract
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Renal artery stenosis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Renal mass
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Subcapsular renal haematoma
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0021 affected76 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Aortic thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Coeliac artery occlusion
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0010 affected357 at risk
EG0021 affected76 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Cataract
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Glaucoma
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Coronavirus pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0012 affected357 at risk
EG0020 affected76 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Periprosthetic fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0020 affected76 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0004 affected356 at risk
EG0015 affected357 at risk
EG0021 affected76 at risk
EG0031 affected73 at risk
EG0044 affected74 at risk
EG0054 affected74 at risk
EG0062 affected70 at risk
EG0071 affected71 at risk
EG0083 affected72 at risk
EG0092 affected73 at risk
Cortisol decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 affected356 at risk
EG0011 affected357 at risk
EG0022 affected76 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG0004 affected356 at risk
EG0011 affected357 at risk
EG0024 affected76 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0008 affected356 at risk
EG0018 affected357 at risk
EG0025 affected76 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0002 affected356 at risk
EG0010 affected357 at risk
EG0020 affected76 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D052801
Male Urogenital Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C570240
empagliflozin
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG004
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG004
74 subjects
FG00574 subjects
FG00670 subjects
FG00771 subjects
FG00872 subjects
FG00973 subjects
50 subjects
FG00455 subjects
FG00558 subjects
FG00661 subjects
FG00754 subjects
FG00848 subjects
FG00966 subjects
19 subjects
FG00516 subjects
FG00610 subjects
FG00718 subjects
FG00824 subjects
FG0097 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Other but not sponsor termination
FG0000 subjects
FG0010 subjects
FG0028 subjects
FG0036 subjects
FG0046 subjects
FG0057 subjects
FG0065 subjects
FG0078 subjects
FG0087 subjects
FG0092 subjects
Protocol deviation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
No reason available
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0052 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
Burden of study procedures
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Change of residence
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG00316 subjects
FG00412 subjects
FG0056 subjects
FG0064 subjects
FG0078 subjects
FG00816 subjects
FG0095 subjects
Not treated with study drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
74
ParticipantsBG00471
ParticipantsBG00572
ParticipantsBG00672
ParticipantsBG00773
ParticipantsBG008586
Title
Measurements
BG00065.4± 11.2
BG00164.4± 12.3
BG00261.8± 12.2
BG00363.4± 10.3
BG00464.4± 11.8
BG00564.8± 9.9
BG00664.3± 10.7
BG00762.3± 11.4
BG00863.8± 11.3
74
ParticipantsBG00374
ParticipantsBG00471
ParticipantsBG00572
ParticipantsBG00672
ParticipantsBG00773
ParticipantsBG008586
Title
Measurements
Female
BG00027
BG00130
BG00220
BG00331
BG00420
BG00523
BG00627
BG00718
BG008196
Male
BG00049
BG00144
BG00254
BG00343
BG004
74
ParticipantsBG00374
ParticipantsBG00471
ParticipantsBG00572
ParticipantsBG00672
ParticipantsBG00773
ParticipantsBG008586
Title
Measurements
Hispanic or Latino
BG00025
BG00121
BG00212
BG00320
BG00422
BG00521
BG00618
BG00724
BG008163
Not Hispanic or Latino
BG00051
BG00153
BG00262
BG00354
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
74
ParticipantsBG00374
ParticipantsBG00471
ParticipantsBG00572
ParticipantsBG00672
ParticipantsBG00773
ParticipantsBG008586
Title
Measurements
American Indian or Alaska Native
BG0000
BG0012
BG0021
BG0032
BG0042
BG0052
BG0063
BG0071
BG00813
Asian
BG00017
BG00127
BG00220
BG00319
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0009
BG0016
BG0027
BG00310
BG004
White
BG00049
BG00135
BG00245
BG00342
BG004
More than one race
BG0001
BG0014
BG0021
BG0031
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
73
ParticipantsBG00274
ParticipantsBG00374
ParticipantsBG00470
ParticipantsBG00571
ParticipantsBG00672
ParticipantsBG00773
ParticipantsBG008583
Title
Measurements
BG000780.3± 828.8
BG001740.8± 915.0
BG002695.4± 748.0
BG003801.4± 1132.3
BG004934.0± 1363.6
BG005646.2± 685.2
BG006785.0± 885.7
BG007684.4± 715.1
BG008757.9± 930.5
133
-0.066
(-0.184 to 0.051)
Other
OG001
OG003
The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
MMRM
<.0001
Mean Difference (Net)
-0.486
2-Sided
95
-0.660
-0.313
Least Squares Mean of "10 mg BI 690517" - Least Squares Mean of "Placebo to BI 690517".
Other
OG002
OG003
The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
MMRM
<.0001
Mean Difference (Net)
-0.421
2-Sided
95
-0.596
-0.246
Least Squares Mean of "20 mg BI 690517" - Least Squares Mean of "Placebo to BI 690517".
Other
OG000
OG001
OG002
OG003
A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod).
MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
MCPMod Emax model fit
Emax model fit assumption: 80% of the maximum effect is achieved at 10 mg.
0.0000
P-value was rounded to four decimal places.
Other
Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.
OG000
OG001
OG002
OG003
A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod).
MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
MCPMod linear model fit
Linear model fit assumption: No assumption is needed.
0.0000
P-value was rounded to four decimal places.
Other
Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.
OG000
OG001
OG002
OG003
A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod). MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
MCPMod exponential model fit
Exponential model fit assumption: 15% of the maximum effect is achieved at 10 mg.
0.0003
Other
Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.
OG001
10 mg BI 690517
This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).
OG002
20 mg BI 690517
This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).
OG003
Placebo to BI 690517
This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
Units
Counts
Participants
OG000128
OG001121
OG002121
OG003133
Title
Denominators
Categories
Title
Measurements
OG000-20.9(-29.9 to -10.8)
OG001-42.5(-49.4 to -34.6)
OG002-38.5(-46.0 to -30.0)
OG003-6.4(-16.8 to 5.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Median Difference (Net)
-15.5
2-Sided
95
-28.6
-0.0
Median of "3 mg BI 690517" - Median of "Placebo to BI 690517".
Other
OG001
OG003
Median Difference (Net)
-38.5
2-Sided
95
-48.3
-26.8
Median of "10 mg BI 690517" - Median of "Placebo to BI 690517".
Other
OG002
OG003
Median Difference (Net)
-34.3
2-Sided
95
-44.9
-21.8
Median of "20 mg BI 690517" - Median of "Placebo to BI 690517".
Other
OG001
Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG002
Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG003
Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Units
Counts
Participants
OG00065
OG00161
OG00259
OG00369
Title
Denominators
Categories
Title
Measurements
OG000-0.254(-0.441 to -0.068)
OG001-0.496(-0.693 to -0.299)
OG002-0.455(-0.666 to -0.245)
OG003-0.027(-0.208 to 0.155)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
MMRM
0.0867
Mean Difference (Net)
-0.227
2-Sided
95
-0.488
0.033
Least Squares Mean of "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" - Least Squares Mean of "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
OG003
The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
MMRM
0.0007
Mean Difference (Net)
-0.469
2-Sided
95
-0.737
-0.201
Least Squares Mean of "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" - Least Squares Mean of "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG002
OG003
The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
MMRM
0.0027
Mean Difference (Net)
-0.429
2-Sided
95
-0.707
-0.151
Least Squares Mean of "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 6905177" - Least Squares Mean of "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG002
Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG003
Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Units
Counts
Participants
OG00065
OG00161
OG00259
OG00369
Title
Denominators
Categories
Title
Measurements
OG000-22.4(-35.6 to -6.5)
OG001-39.1(-50.0 to -25.8)
OG002-36.6(-48.6 to -21.7)
OG003-2.6(-18.8 to 16.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Median Difference (Net)
-20.3
2-Sided
95
-38.6
3.4
Median of "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" - median of "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
OG003
Median Difference (Net)
-37.4
2-Sided
95
-52.2
-18.2
Median of "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" - median of "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517"
Other
OG002
OG003
Median Difference (Net)
-34.9
2-Sided
95
-50.7
-14.0
Median of "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 6905177" - median of "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG002
Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG003
Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.
Units
Counts
Participants
OG00063
OG00160
OG00262
OG00364
Title
Denominators
Categories
Title
Measurements
OG000-0.210(-0.366 to -0.055)
OG001-0.614(-0.783 to -0.445)
OG002-0.516(-0.675 to -0.357)
OG003-0.112(-0.264 to 0.040)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
MMRM
0.3737
Mean Difference (Net)
-0.098
2-Sided
95
-0.316
0.119
Least Squares Mean of "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" - Least Squares Mean of "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG001
OG003
The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
MMRM
<.0001
Mean Difference (Net)
-0.502
2-Sided
95
-0.730
-0.275
Least Squares Mean of "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" - Least Squares Mean of "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG002
OG003
The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
MMRM
0.0004
Mean Difference (Net)
-0.404
2-Sided
95
-0.625
-0.184
Least Squares Mean of "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" - Least Squares Mean of "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG001
Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG002
Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG003
Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.
Units
Counts
Participants
OG00063
OG00160
OG00262
OG00364
Title
Denominators
Categories
Title
Measurements
OG000-19.0(-30.6 to -5.4)
OG001-45.9(-54.3 to -35.9)
OG002-40.3(-49.1 to -30.0)
OG003-10.6(-23.2 to 4.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Median Difference (Net)
-9.4
2-Sided
95
-27.1
12.7
Median of "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" - median of "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG001
OG003
Median Difference (Net)
-39.5
2-Sided
95
-51.8
-24.0
Median of "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" - median of "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG002
OG003
Median Difference (Net)
-33.2
2-Sided
95
-46.5
-16.8
Median of "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" - median of "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
10 mg BI 690517
This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).
OG002
20 mg BI 690517
This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).
OG003
Placebo to BI 690517
This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
Units
Counts
Participants
OG000128
OG001121
OG002121
OG003133
Title
Denominators
Categories
Title
Measurements
OG00040
OG00173
OG00266
OG00324
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0136
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.08
2-Sided
95
1.16
3.72
Odds ratio of "3 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
7.02
2-Sided
95
3.94
12.49
Odds ratio of "10 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
5.48
2-Sided
95
3.09
9.71
Odds ratio of "20 mg BI 690517" vs. "Placebo to BI 690517".
Other
10 mg BI 690517
This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).
OG002
20 mg BI 690517
This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).
OG003
Placebo to BI 690517
This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
Units
Counts
Participants
OG000128
OG001121
OG002121
OG003133
Title
Denominators
Categories
Title
Measurements
OG00040
OG00162
OG00257
OG00323
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0111
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.15
2-Sided
95
1.19
3.88
Odds ratio of "3 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
6.33
2-Sided
95
3.49
11.49
Odds ratio of "10 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
5.21
2-Sided
95
2.88
9.44
Odds ratio of "20 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG001
10 mg BI 690517
This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).
OG002
20 mg BI 690517
This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).
OG003
Placebo to BI 690517
This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
Units
Counts
Participants
OG000128
OG001121
OG002121
OG003133
Title
Denominators
Categories
Title
Measurements
OG00045
OG00167
OG00273
OG00331
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0348
P-value was rounded to four decimal places.
Odds Ratio (OR)
1.80
2-Sided
95
1.04
3.09
Odds ratio of "3 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
4.12
2-Sided
95
2.40
7.08
Odds ratio of "10 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
5.02
2-Sided
95
2.91
8.67
Odds ratio of "20 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG002
20 mg BI 690517
This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).
OG003
Placebo to BI 690517
This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
Units
Counts
Participants
OG000124
OG001107
OG002106
OG003127
Title
Denominators
Categories
Title
Measurements
OG00040
OG00162
OG00257
OG00323
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0111
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.15
2-Sided
95
1.19
3.88
Odds ratio of "3 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
6.33
2-Sided
95
3.49
11.49
Odds ratio of "10 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
5.21
2-Sided
95
2.88
9.44
Odds ratio of "20 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG001
Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG002
Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG003
Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Units
Counts
Participants
OG00065
OG00161
OG00259
OG00369
Title
Denominators
Categories
Title
Measurements
OG00019
OG00131
OG00230
OG00310
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0419
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.44
2-Sided
95
1.03
5.74
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
6.09
2-Sided
95
2.64
14.08
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
6.13
2-Sided
95
2.64
14.25
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG002
Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG003
Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Units
Counts
Participants
OG00065
OG00161
OG00259
OG00369
Title
Denominators
Categories
Title
Measurements
OG00019
OG00128
OG00225
OG0039
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0195
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.88
2-Sided
95
1.19
7.02
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
6.38
2-Sided
95
2.65
15.35
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0001
P-value was rounded to four decimal places.
Odds Ratio (OR)
6.39
2-Sided
95
2.60
15.67
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG002
Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG003
Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Units
Counts
Participants
OG00065
OG00161
OG00259
OG00369
Title
Denominators
Categories
Title
Measurements
OG00022
OG00131
OG00232
OG00314
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0767
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.03
2-Sided
95
0.93
4.42
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0003
P-value was rounded to four decimal places.
Odds Ratio (OR)
4.11
2-Sided
95
1.89
8.91
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0001
P-value was rounded to four decimal places.
Odds Ratio (OR)
4.69
2-Sided
95
2.15
10.24
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG002
Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG003
Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Units
Counts
Participants
OG00061
OG00156
OG00250
OG00366
Title
Denominators
Categories
Title
Measurements
OG00019
OG00128
OG00225
OG0039
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0195
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.88
2-Sided
95
1.19
7.02
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
6.38
2-Sided
95
2.65
15.35
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0001
P-value was rounded to four decimal places.
Odds Ratio (OR)
6.39
2-Sided
95
2.60
15.67
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG002
Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG003
Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.
Units
Counts
Participants
OG00063
OG00160
OG00262
OG00364
Title
Denominators
Categories
Title
Measurements
OG00021
OG00142
OG00236
OG00314
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.1398
P-value was rounded to four decimal places.
Odds Ratio (OR)
1.82
2-Sided
95
0.82
4.04
Odds ratio of "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
8.42
2-Sided
95
3.73
19.02
Odds ratio of "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0001
Odds Ratio (OR)
4.98
2-Sided
95
2.28
10.90
Odds ratio of "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
P-value was rounded to four decimal places.
OG001
Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG002
Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG003
Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.
Units
Counts
Participants
OG00063
OG00160
OG00262
OG00364
Title
Denominators
Categories
Title
Measurements
OG00021
OG00134
OG00232
OG00314
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.1884
P-value was rounded to four decimal places.
Odds Ratio (OR)
1.71
2-Sided
95
0.77
3.79
Odds ratio of "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
6.80
2-Sided
95
2.94
15.72
Odds ratio of "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0003
P-value was rounded to four decimal places.
Odds Ratio (OR)
4.46
2-Sided
95
2.00
9.94
Odds ratio of "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG001
Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG002
Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG003
Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.
Units
Counts
Participants
OG00063
OG00160
OG00262
OG00364
Title
Denominators
Categories
Title
Measurements
OG00023
OG00136
OG00241
OG00317
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.2140
P-value was rounded to four decimal places.
Odds Ratio (OR)
1.62
2-Sided
95
0.76
3.46
Odds ratio of "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0003
P-value was rounded to four decimal places.
Odds Ratio (OR)
4.13
2-Sided
95
1.93
8.85
Odds ratio of "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
5.43
2-Sided
95
2.52
11.71
Odds ratio of "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG002
Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG003
Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.
Units
Counts
Participants
OG00063
OG00151
OG00256
OG00361
Title
Denominators
Categories
Title
Measurements
OG00021
OG00134
OG00232
OG00314
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.1884
P-value was rounded to four decimal places.
Odds Ratio (OR)
1.71
2-Sided
95
0.77
3.79
Odds ratio of "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
6.80
2-Sided
95
2.94
15.72
Odds ratio of "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0003
P-value was rounded to four decimal places.
Odds Ratio (OR)
4.46
2-Sided
95
2.00
9.94
Odds ratio of "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG001
10 mg BI 690517
This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).
OG002
20 mg BI 690517
This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).
OG003
Placebo to BI 690517
This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
Units
Counts
Participants
OG000128
OG001121
OG002121
OG003133
Title
Denominators
Categories
Title
Measurements
OG00068
OG00182
OG00281
OG00346
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0024
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.18
2-Sided
95
1.32
3.61
Odds ratio of "3 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
4.05
2-Sided
95
2.39
6.86
Odds ratio of "10 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
3.87
2-Sided
95
2.29
6.55
Odds ratio of "20 mg BI 690517" vs. "Placebo to BI 690517".
Other
10 mg BI 690517
This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).
OG002
20 mg BI 690517
This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).
OG003
Placebo to BI 690517
This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
Units
Counts
Participants
OG000128
OG001121
OG002121
OG003133
Title
Denominators
Categories
Title
Measurements
OG00067
OG00171
OG00270
OG00344
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0019
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.26
2-Sided
95
1.35
3.77
Odds ratio of "3 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
3.81
2-Sided
95
2.20
6.59
Odds ratio of "10 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
3.67
2-Sided
95
2.12
6.35
Odds ratio of "20 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG001
10 mg BI 690517
This arm includes patients who received during the Treatment Period 10 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 10 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" in the Participant Flow).
OG002
20 mg BI 690517
This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).
OG003
Placebo to BI 690517
This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
Units
Counts
Participants
OG000128
OG001121
OG002121
OG003133
Title
Denominators
Categories
Title
Measurements
OG00067
OG00187
OG00285
OG00353
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0418
P-value was rounded to four decimal places.
Odds Ratio (OR)
1.67
2-Sided
95
1.02
2.74
Odds ratio of "3 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
3.91
2-Sided
95
2.30
6.65
Odds ratio of "10 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
3.58
2-Sided
95
2.11
6.05
Odds ratio of "20 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG002
20 mg BI 690517
This arm includes patients who received during the Treatment Period 20 milligram (mg) of BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" in the Participant Flow) and patients who received during the Treatment period 20 mg BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" in the Participant Flow).
OG003
Placebo to BI 690517
This arm includes patients who received during the Treatment Period Placebo to BI 690517 + 10 mg Empagliflozin (i.e. arm "Treatment period: 10 mg empagliflozin + Placebo to BI 690517" in the Participant Flow) and patients who received during the Treatment period Placebo to BI 690517 + Placebo matching Empagliflozin 10 mg (i.e. arm "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517" in the Participant Flow).
Units
Counts
Participants
OG000124
OG001107
OG002106
OG003127
Title
Denominators
Categories
Title
Measurements
OG00067
OG00171
OG00270
OG00344
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0019
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.26
2-Sided
95
1.35
3.77
Odds ratio of "3 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
3.81
2-Sided
95
2.20
6.59
Odds ratio of "10 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
3.67
2-Sided
95
2.12
6.35
Odds ratio of "20 mg BI 690517" vs. "Placebo to BI 690517".
Other
OG001
Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG002
Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG003
Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Units
Counts
Participants
OG00065
OG00161
OG00259
OG00369
Title
Denominators
Categories
Title
Measurements
OG00033
OG00135
OG00239
OG00322
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0285
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.20
2-Sided
95
1.09
4.45
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0038
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.90
2-Sided
95
1.41
5.96
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0002
P-value was rounded to four decimal places.
Odds Ratio (OR)
4.15
2-Sided
95
1.97
8.72
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG002
Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG003
Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Units
Counts
Participants
OG00065
OG00161
OG00259
OG00369
Title
Denominators
Categories
Title
Measurements
OG00032
OG00132
OG00232
OG00320
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0116
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.56
2-Sided
95
1.23
5.31
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0032
P-value was rounded to four decimal places.
Odds Ratio (OR)
3.08
2-Sided
95
1.46
6.52
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0004
P-value was rounded to four decimal places.
Odds Ratio (OR)
4.07
2-Sided
95
1.86
8.91
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG002
Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG003
Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Units
Counts
Participants
OG00065
OG00161
OG00259
OG00369
Title
Denominators
Categories
Title
Measurements
OG00028
OG00141
OG00241
OG00325
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.4092
P-value was rounded to four decimal places.
Odds Ratio (OR)
1.34
2-Sided
95
0.67
2.69
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0005
P-value was rounded to four decimal places.
Odds Ratio (OR)
3.66
2-Sided
95
1.77
7.58
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0002
P-value was rounded to four decimal places.
Odds Ratio (OR)
4.04
2-Sided
95
1.92
8.49
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG002
Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG003
Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.
Units
Counts
Participants
OG00063
OG00160
OG00262
OG00364
Title
Denominators
Categories
Title
Measurements
OG00035
OG00147
OG00242
OG00324
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0348
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.16
2-Sided
95
1.06
4.43
Odds ratio of "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0000
P-value was rounded to four decimal places.
Odds Ratio (OR)
6.08
2-Sided
95
2.73
13.57
Odds ratio of "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0007
P-value was rounded to four decimal places.
Odds Ratio (OR)
3.58
2-Sided
95
1.71
7.52
Odds ratio of "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG001
Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG002
Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG003
Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.
Units
Counts
Participants
OG00063
OG00160
OG00262
OG00364
Title
Denominators
Categories
Title
Measurements
OG00035
OG00139
OG00238
OG00324
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0578
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.01
2-Sided
95
0.98
4.14
Odds ratio of "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0001
P-value was rounded to four decimal places.
Odds Ratio (OR)
5.12
2-Sided
95
2.23
11.78
Odds ratio of "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0022
P-value was rounded to four decimal places.
Odds Ratio (OR)
3.32
2-Sided
95
1.54
7.16
Odds ratio of "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG001
Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG002
Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG003
Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.
Units
Counts
Participants
OG00063
OG00160
OG00262
OG00364
Title
Denominators
Categories
Title
Measurements
OG00039
OG00146
OG00244
OG00328
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0342
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.17
2-Sided
95
1.06
4.44
Odds ratio of "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0003
P-value was rounded to four decimal places.
Odds Ratio (OR)
4.23
2-Sided
95
1.93
9.24
Odds ratio of "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0023
P-value was rounded to four decimal places.
Odds Ratio (OR)
3.19
2-Sided
95
1.52
6.73
Odds ratio of "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG001
Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG002
Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
OG003
Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517
This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks.
Units
Counts
Participants
OG00061
OG00156
OG00250
OG00366
Title
Denominators
Categories
Title
Measurements
OG00032
OG00132
OG00232
OG00320
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0116
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.56
2-Sided
95
1.23
5.31
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0032
P-value was rounded to four decimal places.
Odds Ratio (OR)
3.08
2-Sided
95
1.46
6.52
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0004
P-value was rounded to four decimal places.
Odds Ratio (OR)
4.07
2-Sided
95
1.86
8.91
Odds ratio of "Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517" vs. "Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517".
Other
Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG002
Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks.
OG003
Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517
This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks.
Units
Counts
Participants
OG00063
OG00151
OG00256
OG00361
Title
Denominators
Categories
Title
Measurements
OG00035
OG00139
OG00238
OG00324
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0578
P-value was rounded to four decimal places.
Odds Ratio (OR)
2.01
2-Sided
95
0.98
4.14
Odds ratio of "Treatment period: 10 mg empagliflozin + 3 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG001
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0001
P-value was rounded to four decimal places.
Odds Ratio (OR)
5.12
2-Sided
95
2.23
11.78
Odds ratio of "Treatment period: 10 mg empagliflozin + 10 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".
Other
OG002
OG003
The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.
Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.
Regression, Logistic
0.0022
P-value was rounded to four decimal places.
Odds Ratio (OR)
3.32
2-Sided
95
1.54
7.16
Odds ratio of "Treatment period: 10 mg empagliflozin + 20 mg BI 690517" vs. "Treatment period: 10 mg empagliflozin + Placebo to BI 690517".