Alogliptin in patients with Type2 Diabetes and Acute Coronary Syndrome

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with Alogliptin in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome

• IRAS ID

  25074

• Contact name

  Adie Viljoen

• Sponsor organisation

  Takeda Global Research & Development Centre (Europe) Ltd.

• Eudract number

  2009-011222-34

• ISRCTN Number

  IRSCTN

• Research summary

  This study is a Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with Alogliptin in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome (ACS). The drug being tested in this study is called alogliptin. Alogliptin improves blood sugar control in people with type 2 diabetes by prolonging the beneficial effects of a substance (GLP-1) released from the gut following meals. The purpose of this study is to assess the safety of alogliptin when given together with standard medications used for care of type 2 diabetes and ACS on the cardiovascular system (i.e. the heart and blood vessels). Approximately 5400 participants at approximately 1000 sites worldwide will participate in the study. This international multi-centre trial will be conducted worldwide in over 40 countries. The overall duration of the study is dependent on the number of primary major adverse cardiac events (MACE); however, the maximum length of follow-up is expected to be approximately 4.75 years. The length of study participation for each participant will vary but is estimated to be a median of 2 years. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups- which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):* Alogliptin 25 mg (or, 12.5mg or 6.25 mg if the participant has moderate or severe renal impairment, respectively) * Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient The participant will be asked to take one tablet at the same time each day throughout the study. The sponsor of this study is Takeda Global Research and Development Centre (Europe) Ltd.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  09/H0709/63

• Date of REC Opinion

  16 Nov 2009

• REC opinion

  Further Information Favourable Opinion