Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS)

• Research type

  Research Study

• Full title

  A Randomised, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycaemic Control on Mono or Dual Combination Oral Antihyperglycaemic Therapy

• IRAS ID

  14910

• Contact name

  Rury Holman

• Sponsor organisation

  Merck & Co.,Inc.

• Eudract number

  2008-006719-20

• Clinicaltrials.gov Identifier

  NCT00790205

• Research summary

  Patients with type 2 diabetes mellitus have high levels of glucose (sugar) in the blood that cause damage to the eyes, kidneys, nerves, and blood vessels and have a high risk of heart attacks and strokes (cardiovascular disease). It is important to determine the effect of medication used to lower blood sugar on cardiovascular health in individuals with diabetes. Merck & Co, Inc. is sponsoring TECOS to test the effect of sitagliptin on cardiovascular outcomes and safety. Sitagliptin is a prescription medicine used to lower blood sugar in adult patients with diabetes. TECOS will evaluate the effect of adding sitagliptin to standard treatment for diabetes. This is a multinational, randomised, double-blind, placebo-controlled trial, meaning that patients will be randomly assigned (like the toss of a coin) to sitagliptin or placebo (dummy drug) and neither the patient nor the study doctor will know which one is given. Patients at least 50 years old who have a history of cardiovascular disease and diabetes mellitus requiring 1-2 medications to control glucose levels will be randomly assigned to one of two treatment groups: ?½ Treatment Arm 1: Sitagliptin standard treatment ?½ Treatment Arm 2: Placebo (look-alike with no active ingredients) standard treatment This is a multicentre study which will include patients in Europe, Asia, Australia, and North and South America. It is anticipated that approximately 14,000 patients will be recruited worldwide, 1050 of those in the UK. Patients will be followed in the study for 4-6 years.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/87

• Date of REC Opinion

  28 Aug 2009

• REC opinion

  Further Information Favourable Opinion