A Study of Aleglitazar in Patients With Type 2 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/3/2016 |
| Start Date: | November 2006 |
| End Date: | March 2008 |
A Randomized, Double-blind Study to Investigate the Effect of Aleglitazar on Glycemic Control in Patients With Type 2 Diabetes Mellitus.
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.
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.
Inclusion Criteria:
- adult patients, 18-75 years of age;
- type 2 diabetes, diagnosed >=1 month of screening;
- either drug-naive, or pretreated with a maximum of 2 oral antihyperglycemic agents at
submaximal doses;
- HbA1c <=10.0% at screening, and 7.0-10.0% at pre-randomisation visit.
Exclusion Criteria:
- type 1 diabetes;
- currently or previously treated with insulin, a thiazolidinedione, or a dual
Peroxisome Proliferator Activated Receptor (PPAR) agonist;
- clinically significant cardiovascular disease;
- Congestive Heart Failure (CHF) New York Heart Association (NYHA) 3-4.
We found this trial at
18
sites
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