Trial · NCT01167881
Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes
NCT01167881, Phase 3, Completed, Boehringer Ingelheim; results first posted 2014-08-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes. Trials, record NCT01167881. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01167881
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes
- NCT number
- NCT01167881
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,549 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- BI 10773, Glimepiride, Placebo, Placebo
- First posted
- 2010-07-22
- Last updated
- 2016-09-02
- Other registries' IDs
- eudract:2009-016244-39
- Results first posted
- 2014-08-08
- Limitations and caveats
- It should be noted that not all patients were followed up for 4 years with regard to the frequencies of adverse events presented up to 4 years.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment. | Baseline and 104 weeks | |
| Secondary | The Change in Body Weight From Baseline After 104 Weeks of Treatment. | baseline and 104 weeks | |
| Secondary | The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment. | baseline and 104 weeks | |
| Secondary | The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment. | baseline and 104 weeks | |
| Secondary | The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment. | baseline and 104 weeks | |
| Secondary | The Change From Baseline in HbA1c After 52 Weeks of Treatment. | baseline and 52 weeks | |
| Secondary | The Change in Body Weight From Baseline After 52 Weeks of Treatment. | baseline and 52 weeks | |
| Secondary | The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment. | baseline and 52 weeks | |
| Secondary | The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment. | baseline and 52 weeks | |
| Secondary | The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment. | baseline and 52 weeks |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | The Change in Body Weight From Baseline After 104 Weeks of Treatment. | baseline and 104 weeks | FAS (LOCF) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values. | kilograms | MEAN |
| PRIMARY | The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment. | Baseline and 104 weeks | FAS (LOCF) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.~. | percentage of HbA1c | MEAN |
| SECONDARY | The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment. | baseline and 104 weeks | Treated set, all patients treated with at least one dose of randomised study drug. | participants | NUMBER |
| SECONDARY | The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment. | baseline and 104 weeks | FAS (LOCF-H) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.~. | mmHg | MEAN |
| SECONDARY | The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment. | baseline and 104 weeks | FAS (LOCF-H) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values. | mmHg | MEAN |
| SECONDARY | The Change From Baseline in HbA1c After 52 Weeks of Treatment. | baseline and 52 weeks | FAS (LOCF) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values. | percentage of HbA1c | MEAN |
| SECONDARY | The Change in Body Weight From Baseline After 52 Weeks of Treatment. | baseline and 52 weeks | FAS (LOCF) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values. | kilograms | MEAN |
| SECONDARY | The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment. | baseline and 52 weeks | Treated set, all patients treated with at least one dose of randomised study drug. | participants | NUMBER |
| SECONDARY | The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment. | baseline and 52 weeks | FAS (LOCF-H) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values. | mmHg | MEAN |
| SECONDARY | The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment. | baseline and 52 weeks | FAS (LOCF-H) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values. | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Change in Body Weight From Baseline After 104 Weeks of Treatment. | Empaglifozin 25 mg | -3.11 | Standard Error 0.13 | kilograms | |
| The Change in Body Weight From Baseline After 104 Weeks of Treatment. | Glimepiride | 1.33 | Standard Error 0.13 | kilograms | |
| The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment. | Empaglifozin 25 mg | -0.66 | Standard Error 0.03 | percentage of HbA1c | |
| The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment. | Glimepiride | -0.55 | Standard Error 0.03 | percentage of HbA1c | |
| The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment. | Empaglifozin 25 mg | 19 | participants | ||
| The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment. | Glimepiride | 189 | participants | ||
| The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment. | Empaglifozin 25 mg | -3.1 | Standard Error 0.5 | mmHg | |
| The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment. | Glimepiride | 2.5 | Standard Error 0.5 | mmHg | |
| The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment. | Empaglifozin 25 mg | -1.8 | Standard Error 0.3 | mmHg | |
| The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment. | Glimepiride | 0.9 | Standard Error 0.3 | mmHg |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Empaglifozin 25 mg | 769 | |
| Overall Study | STARTED | Glimepiride | 780 | |
| Overall Study | Completed After 2 Years Treatment | Empaglifozin 25 mg | 95 | |
| Overall Study | Completed After 2 Years Treatment | Glimepiride | 127 | |
| Overall Study | Completed After 4 Years Treatment | Empaglifozin 25 mg | 515 | |
| Overall Study | Completed After 4 Years Treatment | Glimepiride | 462 | |
| Overall Study | COMPLETED | Empaglifozin 25 mg | 610 | |
| Overall Study | COMPLETED | Glimepiride | 589 | |
| Overall Study | NOT COMPLETED | Empaglifozin 25 mg | 159 | |
| Overall Study | NOT COMPLETED | Glimepiride | 191 |
Source ClinicalTrials.gov
Adverse events630
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 | Empa 25mg | 137 | 765 | |
| other | Urinary tract infection | Infections and infestations | Glimepiride | 121 | 780 | |
| other | Nasopharyngitis | Infections and infestations | Empa 25mg | 90 | 765 | |
| other | Nasopharyngitis | Infections and infestations | Glimepiride | 106 | 780 | |
| other | Upper respiratory tract infection | Infections and infestations | Empa 25mg | 103 | 765 | |
| other | Upper respiratory tract infection | Infections and infestations | Glimepiride | 97 | 780 | |
| other | Influenza | Infections and infestations | Empa 25mg | 71 | 765 | |
| other | Influenza | Infections and infestations | Glimepiride | 73 | 780 | |
| other | Bronchitis | Infections and infestations | Empa 25mg | 34 | 765 | |
| other | Bronchitis | Infections and infestations | Glimepiride | 64 | 780 |
1 to 10 of 630Source ClinicalTrials.gov
See all 630 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Empa 25mg | ||
| Total, all-cause mortality | Glimepiride | ||
| Total, other adverse events | Empa 25mg | 580 | 765 |
| Total, other adverse events | Glimepiride | 637 | 780 |
| Total, serious adverse events | Empa 25mg | 161 | 765 |
| Total, serious adverse events | Glimepiride | 153 | 780 |
Source ClinicalTrials.gov
Papers5
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Empaglifozin 25 mg vs Glimepiride: The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment. | Trial comparisons |
| Empaglifozin 25 mg vs Glimepiride: The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment. | Trial comparisons |
| Empa 25mg vs Glimepiride: serious adverse events | Trial comparisons |
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/NCT01167881
GET https://conductscience.org/api/trials/v1/NCT01167881/events?page=2