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DREAM (Diabetes Reduction Assessment with ramipril and rosiglitazone Medication)

Diabetes is a major and growing health problem worldwide. The DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) Trial is designed to determine if treatment with either ramipril and/or rosiglitazone will prevent or reduce the incidence of diabetes in people with impaired glucose tolerance (IGT). As these two interventions have very different mechanisms of action, the effects are likely to be independent and potentially complementary.

Ramipril has direct effects on the renin-angiotensin-kallikrein system. It may prevent diabetes through effects on the beta cell, and by vascular and metabolic effects on muscle (partially mediated by nitric oxide) that may amplify the effects of insulin. Ramipril's effects on insulin sensitivity therefore appear to be indirect. Rosiglitazone's effect appears to be mediated directly through improved insulin sensitivity and a possible beta cell cytoprotective effect; it does not appear to directly affect the renin-angiotensin-kallikrein system.

The DREAM trial is a large, international, multi-centre, randomized double-blind controlled trial. A total of at least 4000 participants with IGT will be recruited from major international centres over an 18 month period. They will be randomly allocated to either ramipril and/or rosiglitazone using a 2X2 factorial design and followed for at least 3 years after randomization. Participants will be assessed at regular intervals to ascertain the occurrence of the primary outcome (new onset diabetes mellitus or all cause mortality) and other secondary outcomes. A diagnosis of diabetes will be made if 2 consecutive plasma glucose levels exceed the diagnostic thresholds (i.e. a fasting plasma glucose >=7.0 mmol/l (126 mg/dl) or a 2 hr plasma glucose >11.1 mmol/l (200 mg/dl) within a 3 month period. Assuming an annual event rate of 5%, this sample size provides 90% power to detect a 22% reduction in the rate of the primary outcome.

Potential Significance of the Study

Diabetes is clearly a key risk factor for serious health outcomes. This study could provide a potential new strategy for the prevention of type 2 DM as well as provide insights into the relationship between CV disease and DM.

Study Time-table:

Recruitment phase: June 2001-Dec 2002
Follow-up phase: Until Dec. 2005
Study End: Spring 2006

Country Participation: 20 countries (the number of sites/country is in parenthesis)

Argentina (10)
Australia (14)
Bermuda (1)
Brazil (6)
Canada (50)
China (?)
Finland (3)
Germany (6)
Hungary (?)
India (3)
Italy (2)
Mexico (?)
Netherlands (4)
Norway (6)
Poland (4)
Slovakia (1)
Spain (4)
Sweden (2)
Taiwan (?)
Turkey (1)
UK (6)
USA (12)
Number of Centres: 150
Number of Participants: 4000

Study Staff:

Dr. Hertzel Gerstein – Co Principal Investigator
Dr. Salim Yusuf – Co Principle Investigator
 
Ms. Jackie Bosch – Project Manager
Ms. Karen Kimura – Study Coordinator
Ms. Kim Warren – Research/Recruitment Assistant
Ms. Susan Dawkins – Administrative Assistant
Ms. Lori Robinson – Data Management Assistant
Ms. Lisa MacRae – Data Management Assistant

Contact information:

For additional information about the DREAM Trial or to find a DREAM Centre near you please
contact us via:
E-mail: dream@ccc.mcmaster.ca
Phone # (905)-527-4322 ext 44512
FAX # (905)-526-0612

Study Sponsors:

Canadian Institutes of Health Research
Aventis Pharma
Glaxo-Smith Kline
King Pharmaceuticals
Wyeth Ayerst