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NCT01306214 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 566
- Enrollment target
NCT01306214: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01306214 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 566 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01306214, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 566 participants
- Enrollment target
Study Summary
This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.
Primary Outcome
The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.
Interventions
- DRUG Placebo
- DRUG BI 10773
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 566 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
What the finished NCT01306214 record still lists
NCT01306214 is an interventional study that assigns participants to a tested intervention. The registered 566 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01306214 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01306214 about?
NCT01306214 is a clinical study titled "Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus". This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potentia...
What is the current status of trial NCT01306214?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 566 participants. The study started on 2011-02. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01306214?
The interventions under investigation include: Placebo (DRUG), BI 10773 (DRUG).
Who is sponsoring clinical trial NCT01306214?
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 NCT01306214's enrollment target sits among peer trials
566 667th of 2000 higher than 1,334 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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