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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: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01183013 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 936 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.
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 |
What the finished NCT01183013 record still lists
NCT01183013 is an interventional study that assigns participants to a tested intervention. The registered 936 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% higher).
The record links to 0 conditions, and to 5 interventions - of which Pioglitazone 45 mg is the first listed.
NCT01183013 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01183013's enrollment target sits among peer trials
936 338th of 2000 higher than 1,663 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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