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NCT01649297 · ClinicalTrials.gov registry record · Phase 2
A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 983
- Enrollment target
NCT01649297: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT01649297 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 983 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (639% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01649297, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 983 participants
- Enrollment target
Study Summary
The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.
Primary Outcome
Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication. Means provided are the adjusted means.
Interventions
- DRUG Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 983 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT01649297 record still lists
NCT01649297 is an interventional study that assigns participants to a tested intervention. The registered 983 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (639% higher).
The record links to 0 conditions, and to 1 intervention - of which Placebo is the first listed.
NCT01649297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01649297 about?
NCT01649297 is a clinical study titled "A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy". The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This r...
What is the current status of trial NCT01649297?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 983 participants. The study started on 2012-10. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01649297?
The interventions under investigation include: Placebo (DRUG).
Who is sponsoring clinical trial NCT01649297?
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 NCT01649297's enrollment target sits among peer trials
983 27th of 2000 higher than 1,974 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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