Bristol-Myers Squibb Company and AstraZeneca today announced that the European Commission has approved ONGLYZA(R)(saxagliptin) for use as a combination therapy with insulin (with or without metformin) to improve blood sugar (glycaemic) control in adult patients with type 2 diabetes.
The approval was based on Phase 3b 24-week data submitted to the European Medicines Agency which showed that ONGLYZA 5 mg added to insulin (with or without metformin) significantly reduced blood sugar levels (glycosylated hemoglobin levels, or HbA1c) in adult patients with type 2 diabetes, compared to treatment with placebo added to insulin (with or without metformin). In the 28-week extension period of the study, ONGLYZA 5 mg added to insulin (with or without metformin) maintained reductions of HbA1c from 24 to 52 weeks compared to placebo. The proportion of patients who experienced at least one adverse side effect was similar between the two treatment groups.
The data from the 24-week trial were presented at the 71st American Diabetes Association Scientific Sessions in June 2011 and the data from the 28-week extension period were presented at the 47th European Association for the Study of Diabetes Annual Meeting in September 2011.
"Since many patients with type 2 diabetes eventually require insulin, it is important that anti-diabetic treatments can be used with insulin to help patients who are inadequately controlled on their current regimen to reach their treatment goals," said Brian Daniels, M.D., senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb.
"The European approval of ONGLYZA as combination therapy with insulin helps to advance treatment of type 2 diabetes, by offering physicians another option to help patients manage this chronic and progressive disease," said Howard Hutchinson, M.D., chief medical officer, AstraZeneca.