Status:
COMPLETED
A Study of Aleglitazar in Patients With Type 2 Diabetes
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT00388518
Start Date
November 1 2006
End Date
March 1 2008
Last Update
November 2 2016
Active Locations (55)
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1
Phoenix, Arizona, United States, 85006
2
Phoenix, Arizona, United States, 85029
3
Beverly Hills, California, United States, 90211
4
Palm Springs, California, United States, 92262