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Positive Results for Investigational Compound Lyxumia® (Lixisenatide) Presented at American Diabetes Association's 71st Annual Scientific Sessions
Date:6/24/2011

6 kg/m2 and mean A1C 8.0 percent.

Key Findings:

  • Lixisenatide once daily achieved its primary endpoint of  non-inferiority in A1C reduction versus exenatide twice daily (LS mean +/- SE change from baseline: -0.79 +/- 0.05 vs. -0.96 +/- 0.05)
  • Improvements in mean fasting plasma glucose – measurement of blood glucose levels when a patient is fasting – (LS mean +/- SE change from baseline: -22.0 +/- 2.1 vs. -26.1 +/- 2.1) and the percentage of patients achieving the study target A1C < 7.0 percent (48.5% vs. 49.8%) were comparable between groups
  • Mean body weight significantly decreased from baseline in the lixisenatide group compared to the exenatide group (94.5 to 91.7 kg with lixisenatide vs. 96.7 to 92.9 kg with exenatide)
  • The proportion of patients with serious adverse events was generally comparable between groups
  • Discontinuations due to adverse events (mainly gastrointestinal events including nausea, diarrhea and vomiting) were 33 (10.4%) in the lixisenatide group and 41 (13.0%) in the exenatide group
  • Significantly fewer patients experienced symptomatic hypoglycemia with lixisenatide (2.5% vs. 7.9%, p<0.05), with 6-fold fewer hypoglycemic events (8 vs. 48) versus exenatide
  • More lixisenatide patients tolerated the target dose of 20 microgram per day and completed the trial versus the exenatide 10 mcg target dose (93% vs. 83%)

  • "Lixisenatide  Significantly  Improves  Glycemic  Control  in  Asian  Patients   with  Type  2 Diabetes Insufficiently Controlled on Basal Insulin +/- Sulfonylurea" [ABSTRACT 0278-OR]Data from the GetGoal-L Asia trial, showed in  Asian patients with type 2 diabetes insufficiently controlled by basal insulin +/- sulfonylurea, that lixisenatide once daily significantly improved glycemic control (as  measured by the number of patients reaching  a target A1C < 6.5 percent or
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