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NCT01159600 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,504
- Enrollment target
NCT01159600: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01159600 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,504 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01159600, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,504 participants
- Enrollment target
Study Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.
Primary Outcome
Change from baseline in HbA1c after 24 weeks. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Interventions
- DRUG BI 10773
- DRUG Placebo identical to BI 10773 high dose
- DRUG Placebo identical to BI 10773 low dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,504 participants |
| Start Date | 2010-07 |
| Phase | Phase 3 |
What the finished NCT01159600 record still lists
NCT01159600 is an interventional study that assigns participants to a tested intervention. Its 1,504 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 (95% higher).
The record links to 0 conditions, and to 3 interventions - of which BI 10773 is the first listed.
NCT01159600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01159600 about?
NCT01159600 is a clinical study titled "Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes". The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.
What is the current status of trial NCT01159600?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,504 participants. The study started on 2010-07.
What interventions are being tested in trial NCT01159600?
The interventions under investigation include: BI 10773 (DRUG), Placebo identical to BI 10773 high dose (DRUG), Placebo identical to BI 10773 low dose (DRUG).
Who is sponsoring clinical trial NCT01159600?
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 NCT01159600's enrollment target sits among peer trials
1,504 157th of 2000 higher than 1,844 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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