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NCT01183013 · ClinicalTrials.gov registry record · Phase 3
30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 936
- Enrollment target
NCT01183013 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 936 participants.
The verdict
NCT01183013, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 936 participants
- Enrollment target
Study Summary
The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and linagliptin (5 mg, administered orally once daily). In addition, durability of treatment effect and safety under chronic treatment conditions will be investigated.
Interventions
- DRUG Pioglitazone 45 mg
- DRUG Pioglitazone 30 mg
- DRUG Pioglitazone 15 mg
- DRUG Linagliptin 5mg / Pioglitazone 45 mg FDC
- DRUG Linagliptin 5mg / Pioglitazone 30 mg FDC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 936 participants |
| Start Date | 2010-08 |
| Est. Completion | 2013-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01183013
The ClinicalTrials.gov registry entry for NCT01183013 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 936 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 Pioglitazone 45 mg is the first listed.
NCT01183013 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01183013 about?
NCT01183013 is a clinical study titled "30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks". The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and linagliptin (5 mg, adm...
What is the current status of trial NCT01183013?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 936 participants. The study started on 2010-08. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01183013?
The interventions under investigation include: Pioglitazone 45 mg (DRUG), Pioglitazone 30 mg (DRUG), Pioglitazone 15 mg (DRUG), Linagliptin 5mg / Pioglitazone 45 mg FDC (DRUG), Linagliptin 5mg / Pioglitazone 30 mg FDC (DRUG).
Who is sponsoring clinical trial NCT01183013?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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