Late-Stage Study of Diabetes Combo Meets Primary Endpoint, Sanofi Says

The combination involves long-acting insulin and a GLP-1 receptor agonist.

Sanofi announced today it has met the primary endpoint in a phase 3 clinical trial that evaluated a combination its insulin glargine Lantus, its long-acting product that recently came off patent, and Lyxumia (lixisenatide), a prandial GLP-1 receptor agonist that will be resubmitted to FDA this quarter.

The trial, called LixiLan-O, involved 1170 patients whose type 2 diabetes mellitus (T2DM) was not adequately controlled on metformin alone or on metformin with a second oral anti-diabetic agent.

Study participants received metformin and a fixed-ratio combination of 100 units/mL of insulin glargine (Lantus) plus lixisenatide, versus metformin and lixisenatide, or metformin and 100 units/mL of insulin glargine. T2DM patients took therapy for 30 weeks in a once-daily injection.

Patients taking metformin plus the combination therapy “demonstrated statistically superior reduction” in glycated hemoglobin over the previous 3 months, and the fixed-ratio combination “had a safety profile reflecting those of lixisenatide and insulin glargine 100 units/mL,” according to a statement from Sanofi.

“Meeting the primary objective of this important phase 3 study highlights the potential clinical value of this investigational therapeutic option,” said Elias Zerhouni, MD, president of Global Research and Development at Sanofi. “We look forward to advancing the LixiLan program and bringing this combination of insulin glargine and lixisenatide to patients.”

According to the company’s statement, full results will be presented at a future scientific meeting.