Lyxumia(Sanofi-Aventis) positive in GET-GOAL DUO study in Type 2 Diabetes

Lyxumia(lixisenatide) from Sanofi-Aventis, a GLP-1 agonist, in combination with Lantus (insulin glargine) achieved its primary efficacy endpoint of significantly reducing HbA1c, with a significant improvement in post-prandial glucose, in the GetGoal Duo 1 study in patients with Type 2 Diabetes. This randomized, double-blind, placebo-controlled study included a 12-week run-in period with insulin glargine initiated and titrated to reach a target fasting plasma glucose of 80-100 mg/dL followed by a 24-week randomized period where 446 patients with HbA1c >7% - despite controlled fasting plasma glucose - received either lixisenatide once-daily or placebo while insulin glargine and metformin were continued. 88% of patients in the lixisenatide arm reached and remained on the 20 �g maintenance dose. During the run-in period, HbA1c decreased on average from 8.60% to 7.60%. After randomization the addition of lixisenatide led to a further significantly greater HbA1c decrease compared with placebo (p<0.0001) to a mean value of 6.96% after 24 weeks with a significantly higher percentage of patients achieving target hba1c><7.0% with lixisenatide vs. placebo (56.3% vs. 38.5%, respectively, p="0.0001)." lixisenatide also significantly improved 2-h post-prandial glucose with a mean difference of -3.16 mmol l (p><0.0001) vs placebo. the mean difference in change in body weight between the lixisenatide and placebo groups was -0.89 kg (p="0.0012).">