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Sanofi Announces Positive Phase 3 Data for Once-Daily Lixisenatide for Type 2 Diabetes
Date:6/22/2013

-- change was -0.77% with lixisenatide plus standard of care compared with -0.29% with placebo plus standard of care (p<0.0001). The reduction in BHG exposure between lixisenatide plus standard of care and placebo plus standard of care were similar (adjusted LS mean change for AUC24h -234 mg/dl*h vs. -198 mg/dl*h [NS]), but PPG exposure was reduced more with lixisenatide plus standard of care compared with placebo plus standard of care (adjusted LS mean change -378 mg/dl*h vs. -180 mg/dl *h, p<0.0001).

The three Phase 3 studies included in this analysis were part of the GetGoal clinical program and included GetGoal-L, GetGoal-L Asia and GetGoal Duo1. The most common adverse events were nausea, vomiting, diarrhea and symptomatic hypoglycemia which are detailed in the following chart. GetGoal-L

GetGoal-L Asia

GetGoal Duo1Lixisenatide

Placebo

Lixisenatide

Placebo

Lixisenatide

PlaceboDiarrhea

7.3%

5.4%

6.5%

2.5%

6.7%

3.1%Nausea

26.2%

8.4%

39.6%

4.5%

27.4%

4.9%Vomiting

8.2%

0.6%

18.2%

1.9%

9.4%

1.3%Symptomatic

Hypoglycemia

27.7%

21.6%

32.6%

47.2%*

28.3%

21.6%*

22.4%

13.4%Severe

Hypoglycemia

1.2%

0%

-

-

0.4%

0%* Sulfonylurea added to lixisenatide plus basal insulin

"Sanofi is committed to addressing the needs of the 26 million people in the U.S. who are living with diabetes," said Dennis Urbaniak, Vice President and Head of U.S. Diabetes Patient Centered Unit, Sanofi US. "We are encouraged by these results that suggest the potential for lixisenatide to be the first once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes in
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SOURCE Sanofi
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