A Study of Aleglitazar in Patients With Type 2 Diabetes

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT00388518

Run by

Hoffmann-La Roche

People needed

332

Starts

2006-11-01

Expected to finish

2008-03-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — Palm Springs, California, United States
• Study site — San Diego, California, United States
• Study site — Chiefland, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Olive Branch, Mississippi, United States
• Study site — Hamilton, New Jersey, United States
• Study site — New Hyde Park, New York, United States
• Study site — Johnson City, Tennessee, United States
• Study site — Spokane, Washington, United States
• Study site — Athens, Greece
• Study site — Thessaloniki, Greece
• Study site — Hong Kong, Hong Kong
• Study site — Bologna, Italy
• Study site — Genova, Italy
• Study site — Naples, Italy
• Study site — Olbia, Italy
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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