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Sanofi Reports Positive Results from Diabetes Drug Study
- Publisher：
- Publication：2011/4/18
Sanofi-Aventis has reported positive results from the Phase III study evaluating lixisenatide, a once-daily GLP-1 receptor agonist under development for people with type 2 diabetes.
The study achieved its primary efficacy objective of significant HbA1c reduction and improved glycemic control from baseline versus placebo.
The top-line results also revealed that people treated with lixisenatide had a significant decrease in body weight.
The randomised, double-blind, placebo-controlled study was one of nine in the Phase III clinical programme with a 24-week main treatment period.
The study evaluated the efficacy and safety of lixisenatide as an add-on therapy for people with type 2 diabetes whose condition was inadequately controlled by sulfonylureas, with or without metformin.
The study enrolled 859 patients who were randomised to receive either lixisenatide or placebo.
Both groups received a step-wise increase in dose, up to a maintenance dose of 20µg daily.
Lixisenatide is in development for the treatment of patients with type 2 diabetes mellitus. It was in-licensed from Denmark-based Zealand Pharma .
Source: pharmaceutical-technology