Inj Combo Diabetes Drug: Phase 3 Results Announced

Sanofi announced that the LixiLan-O Phase 3 clinical trial of the fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide met its primary objective in patients with type 2 diabetes treated with metformin.

The Phase 3 LixiLan clinical development program consists of the LixiLan-O and LixiLan-L trials. LixiLan-O investigated the efficacy and safety of a once-daily single injection of insulin glargine 100 units/mL and lixisenatide vs. treatment with either lixisenatide or insulin glargine 100 units/mL over a 30 week period in 1,170 patients whose type 2 diabetes was not adequately controlled on metformin alone or on metformin combined with a second oral anti-diabetic agent.

The fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide demonstrated statistically superior reduction in HbA1c (average blood glucose over the previous three months) compared with lixisenatide and compared with insulin glargine 100 units/mL. Overall, the fixed-ratio combination had a safety profile reflecting those of lixisenatide and insulin glargine.

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The ongoing LixiLan-L study investigates the efficacy and safety of a once-daily single injection of the fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide vs. treatment with insulin glargine 100 units/mL over a 30-week period in 736 patients whose type 2 diabetes was not adequately controlled at screening on a basal insulin with or without oral anti-diabetic drugs.

Insulin glargine is a long acting insulin. Lixisenatide is a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA).

For more information visit Sanofi.com.