Diabetes Mellitus Type 2 Clinical Trial
Official title:
A Randomized, Double-blind Study to Investigate the Effect of Aleglitazar on Glycemic Control in Patients With Type 2 Diabetes Mellitus.
Verified date | November 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 332 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Greece, Hong Kong, Italy, Mexico, Romania, Russian Federation, Serbia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Absolute change from baseline in Hemoglobin A1c (HbA1c) | 16 weeks | No | |
Secondary | Absolute change from baseline in Fasting Plasma Glucose (FPG), HbA1c response rate, insulin sensitivity, beta cell function and cardiovascular markers. | 16 weeks | No | |
Secondary | Adverse Events (AEs), laboratory parameters. | Throughout study | No |
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