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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Monotherapy Compared With Placebo in Patients With Type 2 Diabetes Mellitus (T2D) Who Are Drug-Naïve to Anti-Hyperglycemic Therapy
This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Chino, California, United States
Los Angeles, California, United States
Santa Ana, California, United States
Thousand Oaks, California, United States
Upland, California, United States
West Hills, California, United States
Boynton Beach, Florida, United States
Cooper City, Florida, United States
Coral Gables, Florida, United States
Jacksonville, Florida, United States
Start Date
November 1, 2012
Primary Completion Date
September 1, 2013
Completion Date
September 1, 2013
Last Updated
August 11, 2016
196
ACTUAL participants
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