Sanofi Diabetes Drug Meets Primary Endpoint in Phase 3 Trial
Sanofi’s LixiLan met the primary endpoint in a pivotal Phase 3 trial showing a greater drop in average blood glucose in diabetes patients when combined with Lantus (insulin glargine).
The fixed-dose combination of GLP-1 agonist Lyxumia (lixisenatide) and Lantus showed superior reduction in HbA1c compared with insulin alone.
The Lixilan-L trial, which began in 2014, monitored for 30 weeks 736 people whose type 2 diabetes was not adequately controlled on basal insulin. Treatment with metformin, if previously taken, was continued throughout the study. The company says it will release full results of the trial at a future scientific forum.
Sanofi had announced in July that the LixiLan-O Phase 3 study met its primary endpoint in reducing HbA1c in 1,170 people whose metformin treatments alone were not fully effective.
Together, the clinical trials show potential for new tools for diabetes patients to better manage blood sugar levels, the company says.
Another combination treatment for type 2 diabetes patients, Eli Lilly’s and Boehringer Ingelheim’s Glyxambi, was approved in February as the first to bring together two different methods within the same medication to reduce glucose. — Victoria Pelham