The purpose of this study is to determine if ramipril and/or rosiglitazone prevent the onset of type 2 diabetes.

Condition	Treatment or Intervention	Phase
Impaired Glucose Tolerance Cardiovascular Disease Glucose Metabolism Disorders	Drug: Ramipril  Drug: Rosiglitazone	Phase III

Further Study Details: 

Primary Outcomes: diabetes; death
Secondary Outcomes: Myocardial infarction (MI); Stroke; Congestive Heart Failure; Angina; Revascularization procedures; Ventricular Arrhythmia; Renal Events
Expected Total Enrollment:  5000

The DREAM trial is a large, international, multi-centre, randomized double-blind controlled trial. A total of at least 4000 participants with impaired glucose tolerance (IGT) and 1000 participants with isolated impaired fasting glucose (IIFG) 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: This study could provide new strategies for the prevention of type 2 diabetes as well as provide insight into the relationship between cardiovascular disease and diabetes.

Ages Eligible for Study:  30 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• impaired glucose tolerance or isolated impaired fasting glucose

Exclusion Criteria:

• current use of an ACE-inhibitor (ACE-I) or thiazide diuretic (TZD)
• known hypersensitivity to ACE-I
• prior use of anti-diabetic medications (with the exception of during pregnancy)
• use of systemic glucocorticoids or niacin
• congestive heart failure or EF < 40%
• existing cardiovascular disease (previous MI, stroke, angina, uncontrolled hypertension)
• diabetes
• renal or hepatic disease
• major illness
• use of another experimental drug
• pregnant or unwilling to use reliable contraception
• major psychiatric disorder
• diseases that affect glucose tolerance
• unwillingness to be randomized or sign informed consent
• known uncontrolled substance abuse
• inability to communicate with research staff

Study chairs or principal investigators

Salim Yusuf, MD,  Principal Investigator,  McMaster University   
Hertzel Gerstein, MD,  Principal Investigator,  McMaster University   

Study ID Numbers:  DREAM30Nov2002
Record last reviewed:  November 2004
Last Updated:  November 5, 2004
Record first received:  November 5, 2004
ClinicalTrials.gov Identifier:  NCT00095654
Health Authority: United States: Food and Drug Administration; Canada: Therapeutic Products Directorate (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08