Aleglitazar Cardiac Function Study

• Research type

  Research Study

• Full title

  A SINGLE CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, CROSSOVER, PHASE II STUDY TO ASSESS THE EFFECT OF ALEGLITAZAR ON CARDIAC ENERGETICS AND FUNCTION IN PATIENTS WITH UNCOMPLICATED TYPE 2 DIABETES MELLITUS AND NO HISTORY OF CORONARY ARTERY DISEASE WHO ARE DRUG-NAÏVE OR TREATED WITH STABLE METFORMIN MONOTHERAPY

• IRAS ID

  105533

• Contact name

  Paul Leeson

• Sponsor organisation

  Hoffmann La-Roche Ltd

• Eudract number

  2012-001639-29

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study is being carried out to find out whether aleglitazar can improve cardiac energetics and function in patients with uncomplicated type 2 diabetes (T2D) that are otherwise free of coronary artery disease. This will be measured by Magnetic Resonance Spectroscopy (MRS) and Magnetic Resonance Imaging (MRI). This is a one site study run at the Department of Cardiovascular Medicine, John Radcliffe Hospital, Oxford which will recruit 28 patients with T2D and 10 age and sex matched non-diabetic control subjects. This is a double blind, randomised, crossover, placebo-controlled study. It is a 24 week study comprising of a 6 week treatment period (aleglitazar or placebo once daily) followed by a 6 week wash out period and then another 6 week treatment period where patients will receive the opposite drug to the one they had in the first treatment period. Non-diabetic controls will have 2 visits (at screening and baseline) and will not receive any drug. This is to assess the differences in the hearts of diabetic patients against those of non-diabetic patients. Recruitment is expected to take 18 months and patients should be aged 40 to 70 years.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  12/SC/0397

• Date of REC Opinion

  17 Aug 2012

• REC opinion

  Further Information Favourable Opinion