Phase 3 Studies of Lyxumia in Combination with Basal Insulin and Oral Anti-Diabetics for Type 2 Diabetes

Sanofi announced data demonstrating Lyxumia (lixisenatide) in combination with basal insulin plus oral anti-diabetic agents (OADs) significantly reduced HbA1c in people with type 2 diabetes who were either new to insulin therapy or already treated with insulin. Both trials, GetGoal Duo 1 and GetGoal-L, achieved the primary efficacy endpoint of HbA1c improvement with an associated significant reduction in post-prandial glucose (PPG).

GetGoal Duo 1 was a randomized, double-blind, multicenter study assessing the efficacy and safety of lixisenatide compared to placebo in combination with Lantus (insulin glargine; Sanofi) and OADs, mostly metformin (Glucophage; Bristol-Myers Squibb). During the 12-week run-in phase, 898 insulin-naive patients were treated with Lantus, which was titrated to reach a target fasting plasma glucose (FPG) of 80-100mg/dL. After the run-in phase, 446 patients with HbA1c >7% (despite controlled FPG levels) received either once-daily lixisenatide 20mcg or placebo for 24 weeks while metformin and Lantus titration were continued. HbA1c decreased on average from 8.6% to 7.6% during the run-in period with Lantus. 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<0.0001). A significantly higher percentage of patients achieved target HbA1c <7% with lixisenatide compared to placebo (56.3% vs. 38.5%, respectively, P=0.0001). Associated with HbA1c reduction, lixisenatide also significantly improved 2-hour PPG, after a standardized breakfast, with a mean difference of -3.16mmol/L (P<0.0001) compared to placebo.

GetGoal-L was a 24-week randomized, double-blind, multicenter, placebo-controlled study of 495 people with type 2 diabetes insufficiently controlled on basal insulin with or without Glucophage. In the lixisenatide arm, mean HbA1c was significantly reduced from baseline compared to placebo (-0.74% vs. -0.38%, P=0.0002) along with a significant decrease in mean 2-hour PPG (-5.54mmol/L vs. -1.72 mmol/L, P<0.0001) after a standardized breakfast.

Lixisenatide is a glucagon-like peptide-1 agonist (GLP-1) which suppresses glucagon secretion from pancreatic alpha cells and stimulates insulin secretion by pancreatic beta cells.

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