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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 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,413 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01719003
The ClinicalTrials.gov registry entry for NCT01719003 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,413 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 5 interventions - of which Metformin 500 mg bid is the first listed.
NCT01719003 reports 0 study locations.
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.
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