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NCT01422876 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,405
- Enrollment target
NCT01422876 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,405 participants.
The verdict
NCT01422876, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,405 participants
- Enrollment target
Study Summary
This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.
Interventions
- DRUG BI 10773 high dose
- DRUG high dose FDC
- DRUG high dose FDC placebo
- DRUG low dose FDC placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,405 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01422876
The ClinicalTrials.gov registry entry for NCT01422876 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,405 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 4 interventions - of which BI 10773 high dose is the first listed.
NCT01422876 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01422876 about?
NCT01422876 is a clinical study titled "Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients". This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.
What is the current status of trial NCT01422876?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,405 participants. The study started on 2011-08. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01422876?
The interventions under investigation include: BI 10773 high dose (DRUG), high dose FDC (DRUG), high dose FDC placebo (DRUG), low dose FDC placebo (DRUG).
Who is sponsoring clinical trial NCT01422876?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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