Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced results up to 76-weeks from a Phase 3 study of ONGLYZA(TM) (saxagliptin) as initial combination therapy with metformin, which produced long-term glycemic improvement (as measured by glycosylated hemoglobin level (HbA1c)) in treatment-naive adults with type 2 diabetes mellitus inadequately controlled on diet and exercise compared to treatment with an investigational 10 mg dose of saxagliptin or metformin alone. The study results also demonstrated that a higher number of patients were able to achieve the American Diabetes Association recommended HbA1c target of less than 7% with ONGLYZA and metformin as initial combination therapy, compared to monotherapy of either treatment at week 76. The initial combination of ONGLYZA and metformin, with or without pioglitazone rescue therapy, had similar adverse event (AE) rates compared to treatment with investigational saxagliptin or metformin alone. Results were presented at the 70th American Diabetes Association (ADA) Annual Scientific Sessions.
"As type 2 diabetes is a disease that needs to be actively managed, effective treatment options are needed to help improve blood sugar levels," said Andreas Pfutzner, MD, Chief Executive Officer, Institute for Clinical Research and Development, Mainz, Germany. "These data show that at 76 weeks, ONGLYZA and metformin when given as an initial treatment provided improved HbA1c levels for adult patients with type 2 diabetes."
ONGLYZA has been submitted for regulatory review in more than 58 countries and is approved in 43 countries, including the United States, Canada, Mexico, 30 EU countries, Chile, India, Brazil, Argentina and Switzerland. ONGLYZA was approved by the FDA in July 2009 and is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults for the treatment of type 2 diabetes mellitus. ONGLYZA once daily used in combination with commonly prescribed oral anti-diabetic medications - metformin, glyburide (a sulfonylurea) or a thiazolidinedione (TZD), (pioglitazone or rosiglitazone) - or as a monotherapy statistically significantly reduced HbA1c levels. ONGLYZA should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine). ONGLYZA (saxagliptin) has not been studied in combination with insulin.
ASTRAZENECA and BRISTOL-MYERS SQUIBB