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Research

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DREAM

Official Title

The DREAM (Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication) Trial

Status

Completed

Overview

To evaluate whether ramipril and/or rosiglitazone prevent the onset of type 2 diabetes in people with prediabetes and without cardiovascular disease. The trial found no clear benefit for ramipril and a large reduction in incident diabetes with rosiglitazone. Ramipril did not reduce the incidence of CV and renal events; Rosiglitazone reduced the incidence of renal events, had an overall neutral effect on CV events and increased the incidence of heart failure. Based on the trial results rosiglitazone is suggested as a possible therapy to reduce the risk for diabetes in some countries.

Study Design

Randomized, double-blind, placebo control, factorial assignment, efficacy study.

Primary Endpoint

The primary outcome was the composite newly diagnosed diabetes or death. The secondary endpoints include: the composite of CV events (myocardial infarction (MI), stroke, congestive heart failure, angina, revascularization procedures, and ventricular arrhythmia) and renal Events. All primary and secondary outcomes were adjudicated.

Number of Patients

5269

Number of Sites

191

Number of Countries

21

Study Period

2002–2006

Principal Investigator

Hertzel Gerstein

Program Manager

Not Applicable

Research Coordinator

Jackie Bosch

Collaborators

GSK, Aventis

Key Publications

  • DREAM Trial Investigators, Gerstein HC, Yusuf S, Bosch J, Pogue J, Sheridan P, Dinccag N, Hanefeld M, Hoogwerf B, Laakso M, Mohan V, Shaw J, Zinman B, Holman RR. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial. Lancet 2006;368:1096-105.
  • DREAM Trial Investigators, Bosch J, Yusuf S, Gerstein HC, Pogue J, Sheridan P, Dagenais G, Diaz R, Avezum A, Lanas F, Probstfield J, Fodor G, Holman RR. Effect of ramipril on the incidence of diabetes. N Engl J Med. 2006;355:1551-62. Epub 2006 Sep 15.
  • DREAM Trial Investigators, Dagenais GR, Gerstein HC, Holman R, Budaj A, Escalante A, Hedner T, Keltai M, Lonn E, McFarlane S, McQueen M, Teo K, Sheridan P, Bosch J, Pogue J, Yusuf S. Effects of ramipril and rosiglitazone on cardiovascular and renal outcomes in people with impaired glucose tolerance or impaired fasting glucose: results of the Diabetes REduction Assessment with ramipril and rosiglitazone Medication (DREAM) trial. Diabetes Care. 2008;31:1007-14. Epub 2008 Feb 11.