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NCT01691989 · ClinicalTrials.gov registry record · Phase 3
A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin Therapy
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 197
- Enrollment target
- 20
- Study locations
NCT01691989 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Hoffmann-La Roche. The registered enrollment target is 197 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT01691989, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 197 participants
- Enrollment target
- 20
- Study locations
Study Summary
This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar compared with placebo when added to a sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or sulfonylurea plus metformin therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.
Conditions Studied
Interventions
- DRUG placebo
- DRUG aleglitazar
Study Locations (20)
Other
- - Buenos Aires
- - Caba
- - Rosario
- - Bogotá
- - Floridablanca
California
- - Chino
- - Los Angeles
- - San Diego
- - Santa Ana
Florida
- - Jacksonville
- - Kissimmee
- - St. Petersburg
Georgia
- - Atlanta
Indiana
- - Avon
Maryland
- - Bethesda
North Carolina
- - Durham
Pennsylvania
- - Morrisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2012-12 |
| Est. Completion | 2013-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01691989
The ClinicalTrials.gov registry entry for NCT01691989 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 197 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (96% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01691989 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01691989 about?
NCT01691989 is a clinical study titled "A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin Therapy". This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar compared with placebo when added to a sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with type 2 diabetes mellitus who are in...
What is the current status of trial NCT01691989?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 197 participants. The study started on 2012-12. Estimated completion is 2013-09.
What conditions does trial NCT01691989 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT01691989?
The interventions under investigation include: placebo (DRUG), aleglitazar (DRUG).
Who is sponsoring clinical trial NCT01691989?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01691989 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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