Sanofi's GetGoal Phase III study of experimental drug Lyxumia (lixisenatide) met its primary efficacy endpoint when used as an additional therapy to basal insulin (in association with or without metformin).
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Lixisenatide, a glucagon-like peptide-1 agonist (GLP-1), is in development for the treatment of patients with type 2 diabetes mellitus.
The study showed reduction in HbA1c versus placebo for patients who were suffering from type 2 diabetes without increasing their risk of hypoglycemia.
Further, the patients treated with lixisenatide had improved postprandial plasma glucose after a test meal.
Patients in the lixisenatide arm of the study also reported a reduction in body weight.
Sanofi Global Diabetes Division senior vice president Pierre Chancel said these positive efficacy and safety results are another important milestone in the GetGoal clinical trial program and show the potential value of adding Lyxumia (lixisenatide) to basal insulin to improve glycemic control.
"The findings from this and previous studies reinforce a continuing positive trend demonstrating the potential of lixisenatide to improve the lives of people with type 2 diabetes," Chancel said.
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