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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 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 332 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00388518
The ClinicalTrials.gov registry entry for NCT00388518 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 332 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00388518 reports 0 study locations.
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.
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