The Swiss pharmaceutical company Roche pulled the plug on a phase III clinical trial and all other trials involving the diabetes drug aleglitazar “due to safety signals and lack of efficacy.”
The company made the decision based on the recommendation of an independent Data and Safety Monitoring Board, which conducted a safety review of the AleCardio phase III trial. The trial evaluated the efficacy and safety of aleglitazar in patients with a recent acute coronary syndrome event and type 2 diabetes.
Aleglitazar, a peroxisome proliferator-activated receptor agonist that affects glucose and fat control, was shown in a 2009 phase II trial to be safe and effective. Aleglitazar reduced baseline HbA1c levels compared with placebo in a dose-dependent manner. Researchers reported no MI or stroke events but added that the “study was too small to make definitive conclusions.”
Last year Basel-based Roche terminated another phase III study for dalcetrapib, a cholesteryl ester transfer protein inhibitor, due to “lack of clinically meaningful efficacy.” The trial was designed to evaluate the safety and efficacy of dalcetrapib when it was added to standard care in patients with stable coronary heart disease after acute coronary syndrome. Roche chose to discontinue all six trials in the dal-HEART program.
Roche said analysts would look into AleCardio trial data and make the findings available at a medical meeting.