Saxagliptin Assessment of Vascular Outcomes in Type 2 Diabetes

• Research type

  Research Study

• Full title

  SAVOR - Saxagliptin Assessment of Vascular Oucomes Recorded in Patients with Diabetes Mellitus. A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients with Type 2 Diabetes.

• IRAS ID

  43139

• Contact name

  Kausik Ray

• Sponsor organisation

  AstraZeneca

• Eudract number

  2009-017358-10

• ISRCTN Number

  N/A

• Research summary

  Type 2 diabetes Mellitus (T2DM) is characterised by loss of sensitivity to insulin or failure of the beta calls in the pancreas to produce insulin, consequently sugar levels rise (hyperglycaemia) and end organ damage can occur (kidney, eyes, heart and skin) as a result of changes to the blood vessels. Cardiovascular disease is the leading cause of death in patients with type 2 diabetes - more than 60% of all patients die of CV disease and an even greater percentage have serious CV related complications. This study hopes to understand whether saxagliptin is better than placebo at reducing the incidence of Cardiovascular (CV) events (Cardiovascular death, Myocardial Infarction or Ischaemic Stroke) in patients with T2DM. The study will involve 12000 patients (at least 279 from the UK) in approximately 700 centres around the world. T2DM patients with the relevant eligibility criteria will receive either saxagliptin or placebo added onto their background anti diabetic medication. Once randomised they will be seen for a study visit every 6 months to record any CV events and to check for safety, record changes to other medications, check compliance to the study medication, receive more study drug supply and talk to the site staff about dietary and lifestyle advise that could help their diabetes control. In addition, between visits, the site will contact the patient by telephone. As the study is an Endpoint study, the study will finish when the required amount of Endpoints have been recorded. The anticipated duration of the study is approximately 5 years, with a recruitment period of approximately 2 years. The study is sponsored by AstraZeneca in collaboration with Bristol-Myers Squibb and is being done in partnership with the TIMI group (Thrombolysis in Myocardial Infarction) and Hadassah Medical Centre.

• REC name

  London - South East Research Ethics Committee

• REC reference

  10/H1102/23

• Date of REC Opinion

  24 May 2010

• REC opinion

  Further Information Favourable Opinion