Dapagliflozin in subjects with Type II diabetes and hypertension

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects with Type 2 Diabetes with Inadequately Controlled Hypertension treated with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) and an Additional Antihypertensive Medication

• IRAS ID

  66160

• Contact name

  Anthony Barnett

• Sponsor organisation

  Bristol Myers Squibb International Corporation

• Eudract number

  2010-019798-13

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  A significant number of patients with type 2 diabetes have blood pressure that is above the target range, and modest lowering of blood pressure could be beneficial in reducing long-term complications. Previous studies of dapagliflozin completed have been designed to monitor blood pressure as a safety parameter rather than as an efficacy parameter, i.e. to see if dapagliflozin can assist in lowering blood pressure.This trial is designed to evaluate the effects of dapagliflozin on blood pressure when used in subjects with type 2 diabetes who have inadequately controlled hypertension while taking an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) and an additional antihypertensive medication. There will be 2 groups of patients involved in the trial - 1 group will take dapagliflozin and the other will take placebo in addition to the diabetes, ACEI or ARB and additional antihypertensive medication mentioned above.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  10/H0408/104

• Date of REC Opinion

  4 Mar 2011

• REC opinion

  Further Information Favourable Opinion