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This is a study in Chinese adults with type 2 diabetes. The study is open to people who take insulin but still have too high blood sugar levels. Participants may additionally be taking up to 2 other medicines for their diabetes. The purpose of this study is to find out whether empagliflozin taken together with insulin helps people with type 2 diabetes to better control their blood sugar.
The participants are in the study for about 7 months. During this time, they visit the study site about 8 times, 1 additional visit may be either a visit to the study site or a phone call. At the start of the study, participants are put into 3 groups by chance. Participants get either 10 mg empagliflozin tablets, or 25 mg empagliflozin tablets, or placebo tablets once a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine.
The doctors regularly take blood samples from the participants. The changes in blood sugar levels are compared between the groups. The doctors also check the general health of the participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin 10 mg | Experimental | 1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. |
|
| Empagliflozin 25 mg | Experimental | 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. |
|
| Placebo | Placebo Comparator | Matching placebo was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | Empagliflozin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 24 | A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including treatment, background therapy, and visit as fixed classification effects, baseline HbA1c and baseline estimated glomerular filtration rate (eGFR) as the linear covariates, treatment by visit interaction, and baseline HbA1c by visit interaction. | At baseline (Week 0) and at Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HbA1c<7.0% at Week 24 | Percentage of participants with glycosylated haemoglobin A1c (HbA1c) <7.0% at Week 24 is reported. | At Week 24 |
| Change in Body Weight From Baseline to Week 24 |
Not provided
Inclusion Criteria:
Age ≥18 years and ≤75 years old at Visit 1;
Chinese patient with diagnosis of Type 2 diabetes prior to Visit 1;
A stable treatment with premixed Insulin (≥ 20IU/day) or basal insulin (≥ 16 IU/day) for at least 12 weeks prior to enrolment with or without up to two OADs
HbA1c ≥7.5% and ≤11.0% at Visit 1;
Fasting C-peptide: >0.5 ng/mL (>166pmol/L) at Visit 1；
18.5 kg/m2 ≤ BMI ≤ 45 kg/m2 at Visit 1;
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial;
Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | 100034 | China | |||
| Peking University People's Hospital |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
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After the study is completed and the primary manuscript is accepted for publishing, researchers can use this 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".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to 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.
The data shared are the raw clinical study data sets
After 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.
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 both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
4 patients did not meet eligibility criteria but randomized and treated in this trial. The rest of the subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
This study was to determine the efficacy and safety of Empagliflozin added to insulin-treated type 2 diabetes patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. |
| FG001 | Empagliflozin 10 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 20, 2021 | Jan 17, 2023 |
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| Placebo |
| Drug |
Placebo |
|
Change in body weight from baseline to Week 24 is reported. A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline body weight, and its interaction with visit.
| At baseline (Week 0) and at Week 24 |
| Change From Baseline in Systolic Blood Pressure (SBP) at Week 24 | A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline SBP and its interaction with visit. | At baseline (Week 0) and at Week 24 |
| Change From Baseline in Diastolic Blood Pressure (DBP) at Week 24 | A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline DBP and its interaction with visit. | At baseline (Week 0) and at Week 24 |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline FPG and its interaction with visit. | At baseline (Week 0) and at Week 24 |
| Change From Baseline in 2-hour Post-prandial Glucose (PPG) at Week 24 | The Analysis of covariance (ANCOVA) model included treatment and background therapy as classification effects, baseline PPG and baseline Estimated glomerular filtration rate (eGFR) as the linear covariates. | At baseline (Week 0) and at Week 24 |
| Number of Participants With Confirmed Hypoglycaemic Events | Confirmed hypoglycemic events refer to the hypoglycaemic events with a plasma glucose value of ≤70 milligrams per deciliter (mg/dL) or where assistance was required. | From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. |
| Number of Participants With Adjudicated Diabetic Ketoacidosis (DKA) Events | The risk of DKA had to be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty in breathing, confusion, unusual fatigue or sleepiness. In case of a suspected DKA, the investigator was to ensure that appropriate tests were performed at the earliest opportunity according to 2017 China Type 2 diabetes mellitus (T2DM) guidelines. An independent external Clinical event committee (CEC) was established to adjudicate centrally and in a blinded fashion events suspected of DKA and certain hepatic events. DKA was investigated using both broad and narrow Boehringer Ingelheim customised MedDRA query (BIcMQs). | From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. |
| Beijing |
| 100044 |
| China |
| Peking University Third Hospital | Beijing | 100191 | China |
| Beijing Pinggu Hospital | Beijing | 101200 | China |
| The Second Hospital of Jilin University | Changchun | 130041 | China |
| The third xiangya hospital of Central South University | Changsha | 410013 | China |
| The First Hospital, Chongqing Medical University | Chongqing | 400042 | China |
| Chongqing Three Gorges Central Hospital | Chongqing | 404000 | China |
| Third Affiliated Hospital of Guangzhou Medical University | Guangzhou | 510150 | China |
| The Second Affiliated Hospital of Nanjing Medical University | Hangzhou | 210011 | China |
| The Affiliated Hospital of Hangzhou Normal University | Hangzhou | 310015 | China |
| Anhui Provincial Hospital | Hefei | 230001 | China |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | 471000 | China |
| Jiangxi Provincial People's Hospital | Nanchang | 330006 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | 330006 | China |
| The Second Affiliated Hospital to Nanchang University | Nanchang | 330006 | China |
| The affiliated hospital of medicalcollege qingdao university | Qingdao | 266005 | China |
| Tongren hospital, Shanghai Jiaotong University School of Medicine | Shanghai | 200051 | China |
| Centre Hospital of Putuo District, Shanghai | Shanghai | 200062 | China |
| Shanghai Fifth People's Hospital affiliated to Fudan University | Shanghai | 200240 | China |
| Shengjing Hospital of China Medical University | Shenyang | 110072 | China |
| Suzhou Municipal Hospital | Suzhou | 215002 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | 215006 | China |
| Tianjin Medical University Chu Hisen-I Memorial Hospital | Tianjin | 300070 | China |
1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. |
| FG002 | Empagliflozin 25 mg | 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. |
| BG001 | Empagliflozin 10 mg | 1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. |
| BG002 | Empagliflozin 25 mg | 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Glycosylated haemoglobin A1c (HbA1c) | Mean | Standard Deviation | Percentage of glycosylated hemoglobin |
| |||||||||||||||
| Time since diagnosis of diabetes | Mean | Standard Deviation | Years |
| |||||||||||||||
| Background antidiabetic treatment | Count of Participants | Participants |
| ||||||||||||||||
| Type of insulin | Count of Participants | Participants |
|
| 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 Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 24 | A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including treatment, background therapy, and visit as fixed classification effects, baseline HbA1c and baseline estimated glomerular filtration rate (eGFR) as the linear covariates, treatment by visit interaction, and baseline HbA1c by visit interaction. | Modified Intention-to-Treat (mITT) set: The mITT set consisted of all randomised patients who were treated with at least one dose of the study drug and had a baseline HbA1c assessment and at least one on-treatment glycosylated haemoglobin A1c (HbA1c) value. The assignment of patients to treatment groups were based on the planned randomised study drug at the time of randomisation. | Posted | Least Squares Mean | Standard Error | Percentage of glycosylated hemoglobin | At baseline (Week 0) and at Week 24 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HbA1c<7.0% at Week 24 | Percentage of participants with glycosylated haemoglobin A1c (HbA1c) <7.0% at Week 24 is reported. | Modified Intention-to-Treat (mITT) set: The mITT set consisted of all randomised patients who were treated with at least one dose of the study drug and had a baseline HbA1c assessment and at least one on-treatment glycosylated haemoglobin A1c (HbA1c) value. The assignment of patients to treatment groups were based on the planned randomised study drug at the time of randomisation. | Posted | Number | Percentage of participants | At Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Body Weight From Baseline to Week 24 | Change in body weight from baseline to Week 24 is reported. A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline body weight, and its interaction with visit. | Modified Intention-to-Treat (mITT) set: The mITT set consisted of all randomised patients who were treated with at least one dose of the study drug and had a baseline HbA1c assessment and at least one on-treatment glycosylated haemoglobin A1c (HbA1c) value. The assignment of patients to treatment groups were based on the planned randomised study drug at the time of randomisation. | Posted | Least Squares Mean | Standard Error | Kilogram | At baseline (Week 0) and at Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) at Week 24 | A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline SBP and its interaction with visit. | Modified Intention-to-Treat (mITT) set: The mITT set consisted of all randomised patients who were treated with at least one dose of the study drug and had a baseline HbA1c assessment and at least one on-treatment glycosylated haemoglobin A1c (HbA1c) value. The assignment of patients to treatment groups were based on the planned randomised study drug at the time of randomisation. | Posted | Least Squares Mean | Standard Error | Millimetre of mercury (mmHg) | At baseline (Week 0) and at Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Diastolic Blood Pressure (DBP) at Week 24 | A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline DBP and its interaction with visit. | Modified Intention-to-Treat (mITT) set: The mITT set consisted of all randomised patients who were treated with at least one dose of the study drug and had a baseline HbA1c assessment and at least one on-treatment glycosylated haemoglobin A1c (HbA1c) value. The assignment of patients to treatment groups were based on the planned randomised study drug at the time of randomisation. | Posted | Least Squares Mean | Standard Error | Millimetre of mercury (mmHg) | At baseline (Week 0) and at Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline FPG and its interaction with visit. | Modified Intention-to-Treat (mITT) set: The mITT set consisted of all randomised patients who were treated with at least one dose of the study drug and had a baseline HbA1c assessment and at least one on-treatment glycosylated haemoglobin A1c (HbA1c) value. The assignment of patients to treatment groups were based on the planned randomised study drug at the time of randomisation. | Posted | Least Squares Mean | Standard Error | Milligrams per deciliter (mg/dL) | At baseline (Week 0) and at Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 2-hour Post-prandial Glucose (PPG) at Week 24 | The Analysis of covariance (ANCOVA) model included treatment and background therapy as classification effects, baseline PPG and baseline Estimated glomerular filtration rate (eGFR) as the linear covariates. | Modified Intention-to-Treat (mITT) set: The mITT set consisted of all randomised patients who were treated with at least one dose of the study drug and had a baseline HbA1c assessment and at least one on-treatment glycosylated haemoglobin A1c (HbA1c) value. The assignment of patients to treatment groups were based on the planned randomised study drug at the time of randomisation. | Posted | Least Squares Mean | Standard Error | Milligrams per deciliter (mg/dL) | At baseline (Week 0) and at Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Confirmed Hypoglycaemic Events | Confirmed hypoglycemic events refer to the hypoglycaemic events with a plasma glucose value of ≤70 milligrams per deciliter (mg/dL) or where assistance was required. | Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period. | Posted | Count of Participants | Participants | From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adjudicated Diabetic Ketoacidosis (DKA) Events | The risk of DKA had to be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty in breathing, confusion, unusual fatigue or sleepiness. In case of a suspected DKA, the investigator was to ensure that appropriate tests were performed at the earliest opportunity according to 2017 China Type 2 diabetes mellitus (T2DM) guidelines. An independent external Clinical event committee (CEC) was established to adjudicate centrally and in a blinded fashion events suspected of DKA and certain hepatic events. DKA was investigated using both broad and narrow Boehringer Ingelheim customised MedDRA query (BIcMQs). | Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period. | Posted | Count of Participants | Participants | From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days. |
|
For Run-in period group: from first dose of open label placebo till end of run-in period, up to 2 weeks. For the other groups: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days.
Treated set (TS): The TS consisted of all patients who were randomised and treated with at least one dose of the study drug. The assignment of patients to treatment groups were based on the actual first study drug intake in the double-blind treatment period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. | 0 | 73 | 6 | 73 | 39 | 73 |
| EG001 | Empagliflozin 10 mg | 1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. | 0 | 73 | 10 | 73 | 27 | 73 |
| EG002 | Empagliflozin 25 mg | 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. | 0 | 73 | 7 | 73 | 27 | 73 |
| EG003 | Run-in Period | Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablet orally once daily. This group includes all participants who participated the run-in period. | 0 | 219 | 2 | 219 | 46 | 219 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Complicated appendicitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Benign anorectal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 12, 2021 | Jan 17, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C570240 | empagliflozin |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Insulin only |
|
| Pre-mixed |
|
| Mixed model repeated measures |
| < 0.0001 |
| Adjusted mean |
| -0.98 |
| 2-Sided |
| 95 |
| -1.26 |
| -0.70 |
| Other |
A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included "baseline value for the corresponding endpoint" and its interaction with visit as additional covariates. |
1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks.
Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.
|
|
|
| Empagliflozin 25 mg |
1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. |
|
|
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| Empagliflozin 25 mg |
1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. |
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| Empagliflozin 25 mg |
1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. |
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| Empagliflozin 25 mg |
1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. |
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| OG002 |
| Empagliflozin 25 mg |
1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. |
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1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. |
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1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. |
| OG002 | Empagliflozin 25 mg | 1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks. Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily. |
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