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news.Roche has decided to terminate the investigation of aleglitazar following regular safety review of Phase III trial in patients with a recent acute coronary syndrome event and type 2 diabetes.
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Based on the recommendation by the independent Data and Safety Monitoring Board to halt the trial due to safety concerns and lack of efficacy, the company decided to halt AleCardio trial and all other trials involving aleglitazar.
Roche global product development head and chief medical officer Hal Barron said patients’ safety is the first priority.
"Roche is working with investigators to support the management of patients and their transition from aleglitazar treatment to other blood sugar control therapies," Barron added.
"We are disappointed by this outcome as we hoped that aleglitazar would provide significant benefit for patients with type 2 diabetes who are at risk of cardiovascular disease."
The company plans to further analyze the data from the study that evaluated the efficacy and safety of aleglitazar to understand the findings.