Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Hoffmann-La Roche |
---|---|
Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00388518 |
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.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Drug: aleglitazar Drug: Actos Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind Study to Investigate the Effect of Aleglitazar on Glycemic Control in Patients With Type 2 Diabetes Mellitus. |
Enrollment: | 332 |
Study Completion Date: | March 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
|
2: Experimental |
Drug: aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
|
3: Experimental |
Drug: aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
|
4: Experimental |
Drug: aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
|
5: Active Comparator |
Drug: Actos
45mg po daily
|
6: Placebo Comparator |
Drug: Placebo
po daily
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | BM17864 |
Study First Received: | October 16, 2006 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00388518 |
Health Authority: | United States: Food and Drug Administration |
Metabolic Diseases Pioglitazone Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |