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NCT01398267 · ClinicalTrials.gov registry record · Phase 1
A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT01398267: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT01398267 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01398267, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the effect of aleglitazar on renal function, the renin-angiotensin system and the pharmacokinetics of lisinopril in patients with type 2 diabetes mellitus treated with lisinopril. Patients on a stable dose of lisinopril (20 mg daily orally) for 2 weeks will be randomized to receive either aleglitazar (150 mcg orally daily) or placebo in addition to lisinopril for 4 weeks.
Interventions
- DRUG placebo
- DRUG aleglitazar
- DRUG lisinopril
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
What the finished NCT01398267 record still lists
NCT01398267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01398267 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01398267 about?
NCT01398267 is a clinical study titled "A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril". This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the effect of aleglitazar on renal function, the renin-angiotensin system and the pharmacokinetics of lisinopril in patients with type 2 diabetes mellitus treated with lisinopril. Patients on a stable dose of lisin...
What is the current status of trial NCT01398267?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2011-08. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01398267?
The interventions under investigation include: placebo (DRUG), aleglitazar (DRUG), lisinopril (DRUG).
Who is sponsoring clinical trial NCT01398267?
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 NCT01398267's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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