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NCT01422876 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,405
- Enrollment target
NCT01422876: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01422876 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,405 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01422876, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,405 participants
- Enrollment target
Study Summary
This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.
Primary Outcome
Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.
Interventions
- DRUG BI 10773 high dose
- DRUG high dose FDC
- DRUG high dose FDC placebo
- DRUG low dose FDC placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,405 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-09 |
| Phase | Phase 3 |
What the finished NCT01422876 record still lists
NCT01422876 is an interventional study that assigns participants to a tested intervention. Its 1,405 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% higher).
The record links to 0 conditions, and to 4 interventions - of which BI 10773 high dose is the first listed.
NCT01422876 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01422876 about?
NCT01422876 is a clinical study titled "Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients". This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.
What is the current status of trial NCT01422876?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,405 participants. The study started on 2011-08. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01422876?
The interventions under investigation include: BI 10773 high dose (DRUG), high dose FDC (DRUG), high dose FDC placebo (DRUG), low dose FDC placebo (DRUG).
Who is sponsoring clinical trial NCT01422876?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01422876's enrollment target sits among peer trials
1,405 172nd of 2000 higher than 1,829 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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