Lixisenatide Provides Significant Glucose Control in Clinical Trials


In late-stage clinical trials, Sanofi-Aventis’ new experimental drug Lixisenatide has demonstrated significant improvement in glucose control in patients with Type 2 Diabetes. The results of the trial were presented at the 46th Annual Meeting of the European Association for the Study of Diabetes in Stockholm, Sweden.

Lixisenatide Injections Lowered Post-Prandial Glucose and Achieved Normal A1C Levels

Lixisenatide is a once-daily injected medication that acts as a GLP-1 receptor agonist which helps lower glucose levels. A similar medication is Byetta, marketed by Amylin Pharmaceuticals.

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The 12-week Phase III trial enrolled a total of 361 patients with Type 2 Diabetes who were not currently receiving a glucose-lowering therapy. The patients were randomized to receive either Lixisenatide in a two-step titration, Lixisenatide in a one-step titration, or a placebo.

Two-hour postprandial (after eating) blood glucose levels were decreased in both groups receiving Lixisenatide. A decrease in body weight was also observed. Lixisenatide significantly reduced A1C levels in both titration groups over those that received the placebo. Almost 32% of those receiving the two-step titration achieved an A1C less than or equal to 6.5% - the target for glucose control. Just over 25% of the participants receiving the one-step titration reached the target, while less than 7% of the placebo group obtained glucose control.

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Sanofi-Aventis also stated that the medication had an acceptable safety profile in clinical trials of patients with Type 2 Diabetes. Only one serious adverse event occurred that required treatment. Nausea was the most frequent compliant and symptomatic hypoglycemia occurred in 1.7% of patients.

The next results of the GetGoal phase III program are expected to be released in the second quarter of 2011. Future trials will also combine Lixisenatide with Lantus (insulin glargine), also made by Sanofi-Aventis says lead investigator Dr. John E. Gerich of the University of Rochester School of Medicine.