Results of an investigational Phase 3b clinical study, presented by Bristol-Myers Squibb Company and AstraZeneca at the 47th European Association for the Study of Diabetes (EASD), have shown that adding ONGLYZA (saxagliptin) 5 mg to ongoing insulin therapy (with or without metformin) maintained reductions of blood sugar levels (glycosylated hemoglobin levels, or HbA1c) in adult patients with type 2 diabetes.
In the 52-week analysis, which is an extension of a 24-week trial presented at the 71st American Diabetes Association (ADA) Scientific Sessions in San Diego, change from baseline in HbA1c in patients taking ONGLYZA 5 mg added to insulin (with or without metformin) was -0.75% compared to -0.38% for those taking placebo added to insulin (with or without metformin). There was also a greater increase from baseline mean daily insulin dose in patients who received placebo compared to patients who received ONGLYZA 5 mg (with or without metformin). It is unknown whether increased insulin doses by patients in the placebo group could have affected the magnitude of differences seen between the two treatment groups in the efficacy analyses.
The proportion of patients in each treatment group who experienced at least one adverse event over the 52-week treatment period was similar. The most common events included hypoglycemia, urinary tract infection, nasopharyngitis, upper respiratory tract infection, headache and bronchitis.