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Roche to Commence Phase III Trials with Innovative Treatment Designed to Lower Cardiovascular Risk in Diabetes Patients with Recent Heart Attack
Date:6/9/2009

atal myocardial infarction and stroke in patients with type 2 diabetes. The approach in this selected high-risk patient population will be unique as no drug has been demonstrated to reduce cardiovascular risk in type 2 diabetes patients following an ACS event.

Professor Robert Henry, SYNCHRONY Clinical Investigator and Chief VA Endocrinology & Metabolism and Professor of Medicine in Residence at the University of California at San Diego, commented: "The favorable balance in the safety and efficacy profile of aleglitazar seen in the SYNCHRONY study represents encouraging short-term clinical data for this agent and provides good evidence to enter Phase III investigation."

With the decision to move into Phase III, aleglitazar is Roche's third Phase III clinical trial program in the area of metabolism. The new Phase III study is a cardiovascular outcomes trial designed to assess the potential of once-daily 150 micrograms aleglitazar to reduce cardiovascular mortality, non-fatal myocardial infarction and stroke in type 2 diabetes patients with a recent ACS.

About the SYNCHRONY Study

SYNCHRONY was a multicenter, randomized, double-blind, placebo-controlled dose ranging study among 332 type 2 diabetes patients (either drug-naive or pre-treated with less than or equal to 2 oral agents). Designed to determine the glucose-lowering and lipid-modifying effects, and safety profile of aleglitazar, the study confirmed the favorable safety and efficacy profile of the once daily 150 microgram aleglitazar dose and supported commencement of the Phase III clinical investigation.

Patients underwent a single-blind 4- to 5-week placebo run-in period, then were randomized to receive 16 weeks treatment with either aleglitazar at one of four once daily doses (50, 150, 300 or 600 micrograms), placebo or 45 mg pioglitazone.

The primary endpoint of dose-dependent reduction
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SOURCE Roche
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