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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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Beverly Hills, California, United States
Palm Springs, California, United States
San Diego, California, United States
Chiefland, Florida, United States
Hollywood, Florida, United States
West Palm Beach, Florida, United States
Augusta, Georgia, United States
Idaho Falls, Idaho, United States
Start Date
November 1, 2006
Primary Completion Date
March 1, 2008
Completion Date
March 1, 2008
Last Updated
November 2, 2016
332
ACTUAL participants
Actos
DRUG
Placebo
DRUG
aleglitazar
DRUG
Lead Sponsor
Hoffmann-La Roche
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03821636