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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

< 7.0 percent) versus placebo at week 24 with a pronounced post-prandial glucose and fasting plasma glucose effect, and was well tolerated.

Key Findings:

  • Lixisenatide once daily significantly improved A1C versus placebo (LS mean difference -0.9%)
  • Significantly more lixisenatide patients achieved A1C less than or equal to 6.5 percent (17.8%) and <7.0 percent (35.6%) versus placebo (1.3% and 5.2%; p<0.0001)
  • Lixisenatide significantly improved two-hour  post-prandial  glucose, glucose excursion and average  7-point  self-measured  plasma  glucose  (SMPG)  over  placebo  (LS  mean  +/-  SE change from baseline: 7.96 +/- 0.598 vs. -0.14 +/- 0.563, p<0.0001; -7.09 +/- 0.576 vs. 0.14 +/- 0.542, p<0.0001; -1.91 +/- 0.272 vs. -0.56 +/- 0.271, p<0.0001, respectively)
  • Lixisenatide  was  well  tolerated  and  86  percent  of  patients  in  the  lixisenatide  group completed the study versus 92 percent on placebo
  • Nine placebo patients (5.7%) and ten lixisenatide patients  (6.5%) experienced a serious treatment emergent adverse event and more lixisenatide patients (14 [9.1%]) discontinued participation in the study due to treatment emergent adverse events than placebo patients (5 [3.2%]), mainly due to gastrointestinal adverse events
  • As expected in an insulin +/- sulfonylurea-treated population, the percentage of patients with symptomatic hypoglycemia was higher with lixisenatide (42.9%) versus placebo (23.6%); the rate decreased to 31.8 percent versus 28.3 percent in those not receiving sulfonylurea
  • There were no cases of severe hypoglycemia

    • "Cardioprotective Effect of the GLP-1 Receptor Agonist Lixisenatide on Ischemia- Reperfusion-Induced Injury in the Isolated Rat Heart" [ABSTRACT 0968-P]In this pre-clinical study, data showed that lixisenatide on
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