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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

- SYNCHRONY Study Published in The Lancet Supports Cardio-Protective Potential of Aleglitazar -

NUTLEY, N.J., June 9 /PRNewswire/ -- Roche today announced it will start Phase III clinical investigations for aleglitazar, its innovative PPAR co-agonist R1439 which is uniquely designed to reduce cardiovascular morbidity and mortality in high risk patients with type 2 diabetes. This decision is supported by data from the Phase II SYNCHRONY study published today in The Lancet(1) and announced at the American Diabetes Association meeting in New Orleans. The Phase III program is anticipated to start in the second half of 2009.

SYNCHRONY, a placebo-controlled dose ranging study in type 2 diabetes patients, showed that aleglitazar had a balanced synergistic effect on both lipid and glucose control with a good safety and tolerability profile in patients with type 2 diabetes.

Cardiovascular disease is currently the leading cause of death among those with type 2 diabetes, accounting for half of all deaths.(2) Despite guidelines recommending that cardiovascular risk in this patient group should be reduced by controlling factors such as dyslipidemia, blood pressure, body weight and hyperglycemia,(3,4) the majority of patients still do not achieve their treatment goals leaving them vulnerable to both initial and residual cardiovascular events.(3,5) Significantly, one in ten patients with an acute myocardial infarction died within a year.(6)

"Roche is confident that aleglitazar has the potential to reduce cardiovascular morbidity and mortality in this high-risk patient group and is therefore committed to pursuing its rapid development," said Jean-Jacques Garaud, Global Head of Development Pharmaceuticals Division of Roche.

The focused Phase III outcomes trial will investigate whether once daily 150 micrograms aleglitazar reduces the incidence of cardiovascular mortality, non-f
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SOURCE Roche
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