Top-line results for SAVOR-TIMI-53 cardiovascular outcomes trial of ONGLYZA® (SAXAGLIPTIN)

AstraZeneca and Bristol-Myers Squibb announced today top-line results of the Phase IV SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of Onglyza ® (saxagliptin). In this study of adult patients with type 2 diabetes with either a history of established cardiovascular disease or multiple risk factors, Onglyza met the primary safety objective of non inferiority, and did not meet the primary efficacy objective of superiority, for a composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke, when added to a patient’s current standard of care (with or without other anti-diabetic therapies), as compared to placebo.

These preliminary SAVOR-TIMI-53 data are being analysed and the study results will be submitted to the European Society of Cardiology (ESC) for potential presentation at the ESC Congress in September.

About Onglyza® (saxagliptin)

Onglyza is indicated as an adjunct to diet and exercise to improve glycemic (blood sugar) control in adults with type 2 diabetes mellitus in multiple clinical settings. Onglyza should not be used for the treatment of patients with type 1 diabetes mellitus or diabetic ketoacidosis (increased levels of ketones in the blood or urine), as it would not be effective in these settings. Onglyza has not been studied in patients with a history of pancreatitis.

Onglyza is contraindicated in patients with a history of a serious hypersensitivity reaction to Onglyza (e.g., anaphylaxis, angioedema or exfoliative skin conditions). There have been post-marketing reports of acute pancreatitis and serious hypersensitivity reactions in patients taking Onglyza. If pancreatitis or a serious hypersensitivity reaction is suspected, promptly discontinue Onglyza and institute appropriate medical treatment. It is unknown whether patients with a history of pancreatitis are at an increased risk for development of pancreatitis while using Onglyza.

When Onglyza was used in combination with a sulfonylurea or with insulin (two medications known to cause hypoglycemia), the incidence of confirmed hypoglycemia was increased over that of placebo used in combination with a sulfonylurea or with insulin. Therefore, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia when used in combination with Onglyza.

As of June 2013, Onglyza has been submitted for regulatory review in 95 countries and is approved in 86 countries including those in the European Union, the United States, Canada, Mexico, India, Brazil and China.

About SAVOR

SAVOR-TIMI-53 was a randomized, double-blind, placebo-controlled trial that involved 16,500 patients in 25 countries with type 2 diabetes who had a history of established cardiovascular disease or multiple risk factors, with or without renal impairment. SAVOR was led by the academic research organizations TIMI Study Group and Hadassah University Medical Center and conducted at over 700 sites worldwide.