The European Commission has approved Bristol-Myers Squibb Company and AstraZeneca’s ONGLYZA (saxagliptin) for use as a combination therapy with insulin (with or without metformin) to improve blood sugar (glycemic) 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.
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, especially since so many type 2 patients end up using insulin treatment.
ONGLYZA is indicated in adult patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin, sulphonylurea, thiazolidinedione or insulin, when each treatment alone, with diet and exercise, does not provide adequate glycemic control. Sulphonylureas and insulin are known to cause hypoglycemia. Therefore, a lower dose of sulphonylurea or insulin may be required to reduce the risk of hypoglycemia when used in combination with ONGLYZA.
ONGLYZA should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. ONGLYZA is not a substitute for insulin in insulin-requiring patients.