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NCT01719003 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,413
- Enrollment target
NCT01719003: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01719003 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,413 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01719003, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,413 participants
- Enrollment target
Study Summary
This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.
Primary Outcome
Change from baseline in HbA1c (%) after 24 weeks of treatment. "Baseline" refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means
Interventions
- DRUG Metformin 500 mg bid
- DRUG Metformin 1000 mg bid
- DRUG Empagliflozin low dose qd
- DRUG Empagliflozin high dose qd
- DRUG Empagliflozin low dose bid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,413 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT01719003 record still lists
NCT01719003 is an interventional study that assigns participants to a tested intervention. Its 1,413 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 (83% higher).
The record links to 0 conditions, and to 5 interventions - of which Metformin 500 mg bid is the first listed.
NCT01719003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01719003 about?
NCT01719003 is a clinical study titled "Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes". This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus...
What is the current status of trial NCT01719003?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,413 participants. The study started on 2012-10. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01719003?
The interventions under investigation include: Metformin 500 mg bid (DRUG), Metformin 1000 mg bid (DRUG), Empagliflozin low dose qd (DRUG), Empagliflozin high dose qd (DRUG), Empagliflozin low dose bid (DRUG).
Who is sponsoring clinical trial NCT01719003?
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 NCT01719003's enrollment target sits among peer trials
1,413 170th of 2000 higher than 1,831 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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