Saxagliptin Improved Key Measures of Glucose Control When Added to a Sulphonylurea or Thiazolidinedione in People with Inadequately Controlled Type 2 Diabetes

Saxagliptin, an investigational selective inhibitor with extended binding to the dipeptidyl peptidase-4 (DPP-4) enzyme, is being developed jointly by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes.

“A large number of people with type 2 diabetes have difficulty managing their disease and remain uncontrolled on present therapies,” said Professor Anthony Barnett, University of Birmingham and Heart of England NHS Foundation Trust. “Given the growing number of people with diabetes around the world, it is important to investigate new therapeutic options as we fight this chronic disease.”

The companies submitted a New Drug Application to the U.S. Food & Drug Administration (FDA) on 30 June, which was officially filed by the FDA, and a Marketing Authorization Application to the European Medicines Agency (EMEA) on 1 July, which has been accepted for review by the Agency. The submissions are based on data from a comprehensive clinical trial programme conducted in addition to standard therapies, as well as in treatment-naïve patients as a monotherapy. The clinical trial programme included studies that evaluated the drug at up to 80 times the proposed usual clinical dose of 5 mg, once daily. The six core Phase III trials assessing the safety and efficacy of saxagliptin involved more than 4,000 patients, including 3,000 who were treated with saxagliptin.

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