Trial · NCT01289990
Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes
NCT01289990, Phase 3, Completed, Boehringer Ingelheim; results first posted 2014-07-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes. Trials, record NCT01289990. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01289990
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes
- NCT number
- NCT01289990
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,705 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
BI 10773, Placebo, Placebo, Placebo, Placebo, Placebo, BI 10773, Placebo, Placebo, BI 10773, Placebo, Placebo, Placebo, BI 10773, BI 10773, BI 10773, Placebo, BI 10773, Placebo, Placebo, Placebo, Sitagliptin 100mg, BI 10773, Placebo, Placebo, Placebo, Placebo, Placebo, Placebo, Placebo
- First posted
- 2011-02-04
- Last updated
- 2014-07-15
- Other registries' IDs
- eudract:2010-022718-17
- Results first posted
- 2014-07-15
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | Baseline and 52 weeks | Change from baseline in HbA1c after 52 weeks |
| Primary | Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment | Baseline and 76 weeks | Change from baseline in HbA1c after 76 weeks |
| Secondary | HbA1c (%) Changes From Baseline After 76 Weeks of Treatment | Baseline and 76 weeks | Change from baseline in HbA1c (%) after 76 weeks using MMRM approach |
| Secondary | Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | Baseline and 52 weeks | Systolic blood pressure - change from baseline after 52 weeks of treatment |
| Secondary | Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | Baseline and 76 weeks | Systolic blood pressure - change from baseline after 76 weeks of treatment |
| Secondary | Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | Baseline and 52 weeks | Diastolic blood pressure - change from baseline after 52 weeks of treatment |
| Secondary | Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | Baseline and 76 weeks | Diastolic blood pressure - change from baseline after 76 weeks of treatment |
| Secondary | Body Weight (kg) Change From Baseline After 52 Weeks of Treatment | Baseline and 52 weeks | Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment |
| Secondary | Body Weight (kg) Change From Baseline After 76 Weeks of Treatment | Baseline and 76 weeks | Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment |
| Secondary | Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment | Baseline and 52 weeks | Waist circumference (cm) - change from baseline after 52 weeks of treatment |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | Baseline and 52 weeks | Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial.~(LOCF:Last observation carried forward) | % of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | HbA1c (%) Changes From Baseline After 76 Weeks of Treatment | Baseline and 76 weeks | Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial. (OC: Observed cases) | % of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | Baseline and 52 weeks | Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline systolic blood pressure assessment, irrespective of participation in the extension trial. (LOCF) | mmHg | LEAST_SQUARES_MEAN |
| PRIMARY | Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment | Baseline and 76 weeks | Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial. (LOCF) | % of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | Baseline and 76 weeks | Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline systolic blood pressure assessment, irrespective of participation in the extension trial -LOCF | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment | Baseline and 52 weeks | Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline diastolic blood pressure assessment, irrespective of participation in the extension trial -LOCF | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment | Baseline and 76 weeks | Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline diastolic blood pressure assessment, irrespective of participation in the extension trial -LOCF | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Body Weight (kg) Change From Baseline After 52 Weeks of Treatment | Baseline and 52 weeks | Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline body weight assessment, irrespective of participation in the extension trial. - LOCF | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Body Weight (kg) Change From Baseline After 76 Weeks of Treatment | Baseline and 76 weeks | Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline body weight assessment, irrespective of participation in the extension trial -LOCF | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment | Baseline and 52 weeks | Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline waist circumference assessment, irrespective of participation in the extension trial -LOCF | cm | LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group169
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | BI 10773 Low (Drug Naive) | -0.70 | Standard Error 0.05 | % of HbA1c | |
| Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | BI 10773 High (Drug Naive) | -0.82 | Standard Error 0.05 | % of HbA1c | |
| Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | Placebo (Drug Naive) | 0.09 | Standard Error 0.05 | % of HbA1c | |
| Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | Sitagliptin 100mg (Drug Naive) | -0.58 | Standard Error 0.05 | % of HbA1c | |
| Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | BI 10773 Low (Pioglitazone) | -0.63 | Standard Error 0.07 | % of HbA1c | |
| Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | BI 10773 High (Pioglitazone) | -0.71 | Standard Error 0.07 | % of HbA1c | |
| Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | Placebo (Pioglitazone) | -0.03 | Standard Error 0.07 | % of HbA1c | |
| Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | BI 10773 Low (Metformin) | -0.69 | Standard Error 0.05 | % of HbA1c | |
| Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | BI 10773 High (Metformin) | -0.76 | Standard Error 0.05 | % of HbA1c | |
| Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment | Placebo (Metformin) | -0.07 | Standard Error 0.05 | % of HbA1c |
1 to 10 of 169Source ClinicalTrials.gov
See all 169 results by groupParticipant flow39
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Empagliflozin 10 mg (Drug Naive) | 224 | |
| Overall Study | STARTED | Empagliflozin 25 mg (Drug Naive) | 224 | |
| Overall Study | STARTED | Placebo (Drug Naive) | 228 | |
| Overall Study | STARTED | Sitagliptin 100mg (Drug Naive) | 223 | |
| Overall Study | STARTED | Empagliflozin 10 mg (Pioglitazone) | 165 | |
| Overall Study | STARTED | Empagliflozin 25 mg (Pioglitazone) | 168 | |
| Overall Study | STARTED | Placebo (Pioglitazone) | 166 | |
| Overall Study | STARTED | Empagliflozin 10 mg (Metformin) | 217 | |
| Overall Study | STARTED | Empagliflozin 25 mg (Metformin) | 214 | |
| Overall Study | STARTED | Placebo (Metformin) | 207 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 participant flowAdverse events3,627
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Urinary tract infection | Infections and infestations | Empagliflozin 10 mg (Drug Naive) | 21 | 229 | |
| other | Urinary tract infection | Infections and infestations | Empagliflozin 25 mg (Drug Naive) | 20 | 224 | |
| other | Urinary tract infection | Infections and infestations | Placebo (Drug Naive) | 13 | 223 | |
| other | Urinary tract infection | Infections and infestations | Sitagliptin 100mg (Drug Naive) | 18 | 223 | |
| other | Urinary tract infection | Infections and infestations | Empagliflozin 10 mg (Pioglitazone) | 33 | 165 | |
| other | Urinary tract infection | Infections and infestations | Empagliflozin 25 mg (Pioglitazone) | 29 | 165 | |
| other | Urinary tract infection | Infections and infestations | Placebo (Pioglitazone) | 33 | 168 | |
| other | Urinary tract infection | Infections and infestations | Empagliflozin 10 mg (Metformin) | 23 | 206 | |
| other | Urinary tract infection | Infections and infestations | Empagliflozin 25 mg (Metformin) | 25 | 217 | |
| other | Urinary tract infection | Infections and infestations | Placebo (Metformin) | 18 | 214 |
1 to 10 of 3,627Source ClinicalTrials.gov
See all 3,627 adverse eventsAdverse event totals39
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Empagliflozin 10 mg (Drug Naive) | ||
| Total, all-cause mortality | Empagliflozin 25 mg (Drug Naive) | ||
| Total, all-cause mortality | Placebo (Drug Naive) | ||
| Total, all-cause mortality | Sitagliptin 100mg (Drug Naive) | ||
| Total, all-cause mortality | Empagliflozin 10 mg (Pioglitazone) | ||
| Total, all-cause mortality | Empagliflozin 25 mg (Pioglitazone) | ||
| Total, all-cause mortality | Placebo (Pioglitazone) | ||
| Total, all-cause mortality | Empagliflozin 10 mg (Metformin) | ||
| Total, all-cause mortality | Empagliflozin 25 mg (Metformin) | ||
| Total, all-cause mortality | Placebo (Metformin) |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01289990
GET https://conductscience.org/api/trials/v1/NCT01289990/results?page=2