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NCT00388518 · ClinicalTrials.gov registry record · Phase 2
A Study of Aleglitazar in Patients With Type 2 Diabetes
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 332
- Enrollment target
NCT00388518: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT00388518 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 332 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (150% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00388518, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 332 participants
- Enrollment target
Study Summary
This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Interventions
- DRUG Placebo
- DRUG Actos
- DRUG aleglitazar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 332 participants |
| Start Date | 2006-11 |
| Est. Completion | 2008-03 |
| Phase | Phase 2 |
What the finished NCT00388518 record still lists
NCT00388518 is an interventional study that assigns participants to a tested intervention. The registered 332 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (150% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00388518 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00388518 about?
NCT00388518 is a clinical study titled "A Study of Aleglitazar in Patients With Type 2 Diabetes". This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active comparator, or placebo. Alegli...
What is the current status of trial NCT00388518?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 332 participants. The study started on 2006-11. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00388518?
The interventions under investigation include: Placebo (DRUG), Actos (DRUG), aleglitazar (DRUG).
Who is sponsoring clinical trial NCT00388518?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00388518's enrollment target sits among peer trials
332 144th of 2000 higher than 1,856 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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