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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 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 983 participants.
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.
Interventions
- DRUG Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 983 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01649297
The ClinicalTrials.gov registry entry for NCT01649297 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 983 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Placebo is the first listed.
NCT01649297 reports 0 study locations.
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.
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