Sanofi, a global healthcare leader, announced that the LixiLan-L phase III clinical trial met its primary endpoint in patients with type 2 diabetes treated with insulin glargine with or without metformin.
The fixed-ratio combination of insulin glargine 100 units/ml and lixisenatide, a GLP-1 receptor agonist, demonstrated statistically superior reduction in HbA1c (average blood glucose over the previous three months) compared with insulin glargine 100 units/ml. Overall, the fixed-ratio combination had a safety profile reflecting those of insulin glargine 100 units/ml and lixisenatide.
"This study examined an important possible use of this investigational medicine," said Richard M Bergenstal MD, executive director, International Diabetes Center at Park Nicollet, Minneapolis, Minnesota, US.
"The result highlights that this could provide a treatment option for the roughly fifty per cent of patients who are no longer able to remain at their HbA1c target, despite basal insulin treatment."
LixiLan-L investigated the efficacy and safety of the fixed-ratio combination of insulin glargine 100 units/ml and lixisenatide versus 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 basal insulin, alone or combined with one to two oral anti-diabetic agents. Treatment with metformin, if previously taken, was continued throughout the study.
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