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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

s from baseline HbA1c versus placebo was met and a range of responses observed from -0.36% (95% CI:0.00 to -0.70, P=0.048) with 50 micrograms aleglitazar, to -1.35% (95% CI: -0.99 to -1.70, p<0.0001) with the 600 microgram dose. Notably, the once daily 150 microgram aleglitazar dose (currently in clinical trials) demonstrated numerically comparable reductions from baseline HbA1c to those observed with pioglitazone (-0.85%, 95% CI: -0.50 to -1.20, P<0.0001 vs.-0.71%, 95% CI: -0.36 to -1.06, P<0.0001).

The study's secondary clinical endpoints were changed from baseline in fasting plasma glucose and lipid profiles. Notably, significant dose-dependent reductions versus placebo were observed with aleglitazar for fasting plasma glucose (-1.0 mmol/L with 50 micrograms to -3.3 mmol/L with 600 micrograms), triglycerides (-27.8% with 50 micrograms to -51.6% with 600 micrograms), and LDL-C (-9.1% with 50 micrograms to -25.9% with 600 micrograms), as well as a significant dose-dependent increase in HDL-C (8.2% with 50 micrograms to 22.9% with 300 micrograms). Importantly, treatment with the once daily 150 micrograms aleglitazar

dose produced a numerically superior effect on triglycerides, HDL-C, and LDL-C when compared with 45 mg pioglitazone.

Known PPAR-alpha (creatinine increase) and gamma-related effects (edema, haemodilution, and weight gain) were seen in a dose-dependent manner of which the incidence of edema for the 150 microgram aleglitazar dose was similar to placebo and numerically less than with pioglitazone, and body weight gain was numerically less than with pioglitazone.

About Aleglitazar

Aleglitazar is an innovative treatment designed to reduce the incidence and impact of cardiovascular mortality, non-fatal myocardial infarction and stroke in patients with a recent ACS and type 2 diabetes.

It is a rationally designed molecule providing balanced dual PPAR a
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SOURCE Roche
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