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Sanofi has announced data demonstrating Lyxumia ( Lixisenatide ), a once-daily investigational GLP-1 agonist, in combination with basal Insulin plus oral anti-diabetic agents, significantly reduced HbA1c ( glycated hemoglobin ) in people with type 2 diabetes who were either new to Insulin therapy ( as early as 12 weeks after initiation ) or already treated with Insulin ( for an average of 3.1 years ).

Both GetGoal Duo 1 and GetGoal-L studies achieved the primary efficacy endpoint of HbA1c improvement with an associated significant reduction in post-prandial glucose.

Efficacy and safety of once-daily Lixisenatide added on to titrated Glargine plus oral agents in type 2 diabetes: GetGoal Duo 1 study

GetGoal Duo 1 is a randomized, double-blind, multicenter study, assessing the efficacy and safety of Lixisenatide, compared to placebo, in combination with Insulin glargine and oral anti-diabetic agents, ( mostly Metformin ).

During the 12-week run-in phase, 898 insulin-naïve patients were treated with Insulin glargine, which was titrated to reach a target fasting plasma glucose ( FPG ) of 80-100 mg/dL.
After the run-in phase, 446 patients with HbA1c less than 7% ( despite controlled FPG levels ) received either once-daily Lixisenatide 20 microg or placebo for 24 weeks while Metformin and Insulin glargine titration were continued.

HbA1c decreased on average from 8.60% to 7.60% during the run-in period with Insulin glargine. The addition of Lixisenatide led to a further significant HbA1c decrease to a mean value of 6.96% after 24 weeks compared to 7.3% in patients receiving placebo ( p