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New Diabetes Compound AVE0010 Showed Clear Dose Response Results With Once-A-Day Injection in Phase IIb Study
Date:6/7/2008

Results Presented at the ADA's Annual Scientific Sessions

SAN FRANCISCO, June 7 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the results of the dose-finding study for its new injectable diabetes compound AVE0010, a GLP-1 agonist, were presented at the American Diabetes Association's (ADA) 68th Annual Scientific Sessions meeting in San Francisco, California.

The study found that AVE0010 was well tolerated and significantly improved glycemic control versus placebo in type 2 diabetes patients inadequately controlled with metformin alone. The once daily regimen demonstrated a clear dose response with a similar HbA1c reduction to twice daily regimen. AVE0010 was also found to be associated with weight loss and reductions in postprandial glucose.

"The results of the once daily AVE0010 regimen are very promising and this new GLP-1 agonist has a potential to become an important addition to the treatment armamentarium for type 2 diabetes," said Robert Ratner, from the MedStar Research Institute Washington DC, Principal Investigator of the dose-finding study.

About the Study

The dose-finding study involved 542 type 2 diabetes patients inadequately controlled on metformin monotherapy (1.6-1.9 g/day). In this double-blind study, patients were randomized to receive for 13 weeks, either AVE0010 subcutaneously at the doses of 5, 10, 20 and 30 micron(g) once daily or twice daily, or placebo. The primary endpoint was change in HbA1c from baseline. Secondary endpoints included weight change and 2-hour post-prandial plasma glucose (PPG).

Baseline characteristics were similar among groups in terms of mean age (56 +/-9 years), diabetes duration (6.6 +/-5 years), HbA1c (7.5 +/-0.6%) and Body Mass Index (31.9 +/-4 kg/m2). Despite mildly elevated baseline HbA1c, the results of the study demonstrated a highly statistically significant dose response with a net decrease in mean HbA1c from baseline subtracted from placebo f
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