Phase 3 Study of Lyxumia in Combination with Lantus for Type 2 Diabetes

Sanofi announced positive results from its Phase 3, GetGoal Duo 1 study of Lyxumia (lixisenatide) in combination with Lantus (insulin glargine; Sanofi) for the treatment of patients with type 2 diabetes uncontrolled on oral antidiabetics (mainly metformin). GetGoal Duo 1 was a randomized, double-blind, placebo-controlled study. Patients received insulin glargine for a 12-week run-in period, followed by randomized Lyxumia or placebo for 24 weeks.

The study achieved its primary efficacy endpoint of significantly reducing HbA1c compared to placebo (P<0.0001), to a mean value of 6.96% after 24 weeks with a significantly higher percentage of patients achieving target HbA1c<7 with lixisenatide vs. placebo (56.3% vs. 38.5%, respectively, P=0.0001). Lixisenatide also significantly improved two-hour post-prandial glucose with a mean difference of -3.16mmol/L (P<0.0001) vs. placebo.

Lyxumia is a glucagon-like peptide-1 (GLP-1) agonist.

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