A Study of Aleglitazar in Patients With Type 2 Diabetes

Phase 2 Completed 332 enrolled Hoffmann-La Roche

RandomizedParallel-groupDouble-blindTreatment

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 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.

Timeline

Start: 2006-11
Primary completion: 2008-03
Completion: 2008-03

Outcome

Met primary endpoint

paper Aleglitazar significantly reduced baseline HbA(1c) versus placebo in a dose-dependent manner, from -0.36% (95% CI 0.00 to -0.70, p=0.048) PMID 19515415 ↗

Publications

Henry RR, Lincoff AM, Mudaliar S, Rabbia M, Chognot C, Herz M. Effect of the dual peroxisome proliferator-activated receptor-alpha/gamma agonist aleglitazar on risk of cardiovascular disease in patients with type 2 diabetes (SYNCHRONY): a phase II, randomised, dose-ranging study. Lancet. 2009 Jul 11;374(9684):126-35. doi: 10.1016/S0140-6736(09)60870-9. Epub 2009 Jun 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Pioglitazone	Small molecule	45 mg	Oral
Subject	aleglitazar	Small molecule	50 ug	Oral
Subject	aleglitazar	Small molecule	150 ug	Oral
Subject	aleglitazar	Small molecule	300 ug	Oral
Subject	aleglitazar	Small molecule	600 ug	Oral