Onglyza (BMS/AstraZeneca) plus Insulin is EMA approved for Type 2 Diabetes

The European Medicines Agency (EMA) has approved Onglyza (saxagliptin)from BMS/AstraZeneca 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 IIIb 24-week data submitted to EMA 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,Onglyza5 mg added to insulin (with or without metformin) maintained reductions of HbA1c from 24 to 52 weeks compared to placebo.