Bristol-Myers Squibb ( BMS ) and AstraZeneca have announced top line results of the phase 4 SAVOR-TIMI-53 ( Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus ) clinical trial of Saxagliptin ( Onglyza ). 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.

Onglyza is indicated as an adjunct to diet and exercise to improve glycemic 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 hypoglycaemia ), 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.

Source: AstraZeneca and Bristol-Myers Squibb, 2013

XagenaMedicine2013