BI 10773 add-on to Metformin in Patients With Type 2 Diab... | NCT00749190

ID	Type	Description	Link
EudraCT 2008-000641-54

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in HbA1c After 12 Weeks of Treatment	Change from baseline in HbA1c after 12 weeks of treatment. In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.	Baseline and 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change of FPG From Baseline After 12 Weeks of Treatment	Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis. In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.

Eligibility Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1245.10.10026 Boehringer Ingelheim Investigational Site		Chula Vista	California		United States
1245.10.10001 Boehringer Ingelheim Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35472672	Derived	Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
23940010

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
FG001	Empagliflozin 1 mg	Patients receive 1 mg Empagliflozin in tablets once daily.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
BG001	Empa 1 mg	Patients receive 1 mg Empagliflozin in tablets once daily.
BG002	Empa 5 mg	Patients receive 5 mg Empagliflozin in tablets once daily.
BG003	Empa 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
BG004	Empa 25 mg	Patients receive 25 mg Empagliflozin in tablets once daily.
BG005	Empa 50 mg	Patients receive 50 mg Empagliflozin in tablets once daily.
BG006	Sitag	Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
BG007	Total	Total of all reporting groups

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 HbA1c After 12 Weeks of Treatment

Change from baseline in HbA1c after 12 weeks of treatment.

In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.

Full analysis set (FAS) consisting of all randomized patients who were treated with at least one dose of study drug and has a baseline measurement of the primary endpoint. The imputation method used was a modified last observation carried forward (LOCF) approach which used linear interpolation, LOCF and worst observation carried forward (WOCF).

Posted

Mean

Standard Error

percentage of HbA1c

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
OG001	Empagliflozin 1 mg	Patients receive 1 mg Empagliflozin in tablets once daily.
OG002	Empagliflozin 5 mg	Patients receive 5 mg Empagliflozin in tablets once daily.
OG003	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
OG004	Empagliflozin 25 mg	Patients receive 25 mg Empagliflozin in tablets once daily.
OG005	Empagliflozin 50 mg	Patients receive 50 mg Empagliflozin in tablets once daily.
OG006	Sitagliptin OL	Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.

Units	Counts
Participants	OG00071 OG00171 OG00271 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.15± 0.08 OG001-0.09± 0.08 OG002-0.23± 0.08 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 OG001		ANCOVA	Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.	0.0226	P-values are regarded as descriptive, adjustment for multiple testing was not necessary.	Mean Difference (Final Values)	-0.24	Standard Error of the Mean	0.10	2-Sided	95	-0.44	-0.03			Difference calculated as empagliflozin 1 mg minus placebo	No	Superiority or Other

Secondary

Change of FPG From Baseline After 12 Weeks of Treatment

Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.

FAS using modified LOCF imputation method

Posted

Mean

Standard Error

mg/dL

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
OG001	Empagliflozin 1 mg	Patients receive 1 mg Empagliflozin in tablets once daily.
OG002	Empagliflozin 5 mg	Patients receive 5 mg Empagliflozin in tablets once daily.
OG003	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.

Secondary

Change of HbA1c From Baseline Over Time

Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.

FAS. Imputation method used was the classical LOCF (CLOCF) approach which uses always the last available value.

Posted

Mean

Standard Error

percentage of HbA1c

Baseline and weeks 4, 8 and 12

ID	Title	Description
OG000	Placebo	Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
OG001	Empagliflozin 1 mg	Patients receive 1 mg Empagliflozin in tablets once daily.
OG002	Empagliflozin 5 mg	Patients receive 5 mg Empagliflozin in tablets once daily.
OG003	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
OG004	Empagliflozin 25 mg

Secondary

Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment

Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%) based on logistic regression

FAS (CLOCF)

Posted

Number

percentage of participants

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
OG001	Empagliflozin 1 mg	Patients receive 1 mg Empagliflozin in tablets once daily.
OG002	Empagliflozin 5 mg	Patients receive 5 mg Empagliflozin in tablets once daily.
OG003	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
OG004	Empagliflozin 25 mg

Secondary

Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment

Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%) based on logistic regression

FAS (CLOCF)

Posted

Number

percentage of participants

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
OG001	Empagliflozin 1 mg	Patients receive 1 mg Empagliflozin in tablets once daily.
OG002	Empagliflozin 5 mg	Patients receive 5 mg Empagliflozin in tablets once daily.
OG003	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
OG004	Empagliflozin 25 mg

Secondary

Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)

Results for change of FPI from baseline at week 12 based on ANCOVA

FAS (CLOCF)

Posted

Mean

Standard Error

mU/L

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
OG001	Empagliflozin 1 mg	Patients receive 1 mg Empagliflozin in tablets once daily.
OG002	Empagliflozin 5 mg	Patients receive 5 mg Empagliflozin in tablets once daily.
OG003	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
OG004	Empagliflozin 25 mg	Patients receive 25 mg Empagliflozin in tablets once daily.

Secondary

Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)

HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.

FAS (CLOCF)

Posted

Mean

Standard Error

mU/L x mmol/L

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
OG001	Empagliflozin 1 mg	Patients receive 1 mg Empagliflozin in tablets once daily.
OG002	Empagliflozin 5 mg	Patients receive 5 mg Empagliflozin in tablets once daily.
OG003	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
OG004	Empagliflozin 25 mg	Patients receive 25 mg Empagliflozin in tablets once daily.

Secondary

Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)

HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5), FPG in mg/dl. Results are based on ANCOVA.

FAS (CLOCF)

Posted

Mean

Standard Error

mU / mmol

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
OG001	Empagliflozin 1 mg	Patients receive 1 mg Empagliflozin in tablets once daily.
OG002	Empagliflozin 5 mg	Patients receive 5 mg Empagliflozin in tablets once daily.
OG003	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
OG004	Empagliflozin 25 mg

Secondary

Change of Body Weight After 12 Weeks of Treatment

Results for change of body weight after 12 weeks of treatment based on ANCOVA.

FAS (CLOCF)

Posted

Mean

Standard Error

Baseline and 12 weeks

ID	Title	Description
OG000	Placebo	Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
OG001	Empagliflozin 1 mg	Patients receive 1 mg Empagliflozin in tablets once daily.
OG002	Empagliflozin 5 mg	Patients receive 5 mg Empagliflozin in tablets once daily.
OG003	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
OG004	Empagliflozin 25 mg	Patients receive 25 mg Empagliflozin in tablets once daily.

Secondary

Trough Concentrations of Empagliflozin in Plasma

(Pre-dose) trough concentrations of Empagliflozin in plasma, within 30 minutes of dosing.

All patients who received at least one dose of Empagliflozin and have some Pharmacokinetic (PK) data.

Posted

Geometric Mean

Geometric Coefficient of Variation

nmol/L

Days 28, 56 and 84

ID	Title	Description
OG000	Empagliflozin 1 mg	Patients receive 1 mg Empagliflozin in tablets once daily.
OG001	Empagliflozin 5 mg	Patients receive 5 mg Empagliflozin in tablets once daily.
OG002	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
OG003	Empagliflozin 25 mg	Patients receive 25 mg Empagliflozin in tablets once daily.
OG004	Empagliflozin 50 mg

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.	2	71	4	71
EG001	Empagliflozin 1 mg	Patients receive 1 mg Empagliflozin in tablets once daily.	0	71	2	71
EG002	Empagliflozin 5 mg	Patients receive 5 mg Empagliflozin in tablets once daily.	3	71	2	71
EG003	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.	1	71	7	71
EG004	Empagliflozin 25 mg	Patients receive 25 mg Empagliflozin in tablets once daily.	2	70	4	70
EG005	Empagliflozin 50 mg	Patients receive 50 mg Empagliflozin in tablets once daily.	3	70	3	70
EG006	Sitagliptin OL	Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.	0	71	4	71

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MEDDRA 12.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG0031 affected71 at risk EG0040 affected70 at risk EG0050 affected70 at risk EG0060 affected71 at risk
Coronary artery disease	Cardiac disorders	MEDDRA 12.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Myocardial infarction	Cardiac disorders	MEDDRA 12.0	Systematic Assessment	EG0001 affected71 at risk EG0010 affected71 at risk EG0021 affected71 at risk EG003
Myocardial ischaemia	Cardiac disorders	MEDDRA 12.0	Systematic Assessment	EG0001 affected71 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Thyroid cyst	Endocrine disorders	MEDDRA 12.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected71 at risk EG0021 affected71 at risk EG003
Chest discomfort	General disorders	MEDDRA 12.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Chest pain	General disorders	MEDDRA 12.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MEDDRA 12.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Pneumonia	Infections and infestations	MEDDRA 12.0	Systematic Assessment	EG0001 affected71 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Pyelonephritis	Infections and infestations	MEDDRA 12.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MEDDRA 12.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 12.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected71 at risk EG0021 affected71 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MEDDRA 12.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected71 at risk EG0020 affected71 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Urinary tract infection	Infections and infestations	MEDDRA 12.0	Systematic Assessment		EG0002 affected71 at risk EG0012 affected71 at risk EG0021 affected71 at risk EG0033 affected71 at risk EG0044 affected70 at risk EG0051 affected70 at risk EG0062 affected71 at risk
Hypertension	Vascular disorders	MEDDRA 12.0	Systematic Assessment		EG0002 affected71 at risk EG0010 affected71 at risk EG0021 affected71 at risk EG003

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011719	Pyrazines