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NCT01177813 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 986
- Enrollment target
NCT01177813: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01177813 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 986 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01177813, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 986 participants
- Enrollment target
Study Summary
The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.
Primary Outcome
The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.
Interventions
- DRUG BI 10773
- DRUG Placebo identical to BI10773 high dose
- DRUG BI 10773 open label
- DRUG Placebo identical to BI10773 low dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 986 participants |
| Start Date | 2010-07 |
| Phase | Phase 3 |
What the finished NCT01177813 record still lists
NCT01177813 is an interventional study that assigns participants to a tested intervention. The registered 986 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% higher).
The record links to 0 conditions, and to 4 interventions - of which BI 10773 is the first listed.
NCT01177813 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01177813 about?
NCT01177813 is a clinical study titled "Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes". The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy an...
What is the current status of trial NCT01177813?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 986 participants. The study started on 2010-07.
What interventions are being tested in trial NCT01177813?
The interventions under investigation include: BI 10773 (DRUG), Placebo identical to BI10773 high dose (DRUG), BI 10773 open label (DRUG), Placebo identical to BI10773 low dose (DRUG).
Who is sponsoring clinical trial NCT01177813?
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 NCT01177813's enrollment target sits among peer trials
986 320th of 2000 higher than 1,681 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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