Status:
COMPLETED
The DREAM (Diabetes Reduction Assessment With Ramipril and Rosiglitazone Medication) Trial
Lead Sponsor:
Gerstein, Hertzel, MD
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Aventis Pharmaceuticals
Conditions:
Impaired Glucose Tolerance
Cardiovascular Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if ramipril and/or rosiglitazone prevent the onset of type 2 diabetes.
Detailed Description
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 wit...
Eligibility Criteria
Inclusion
- impaired glucose tolerance (FPG \< 7 mmol/L or 126 mg/dL AND 2 hr PG \>= 7.8 mmol/L and \< 11.1 mmol/L (140 mg/dL and \< 200 mg/dL)or,
- isolated impaired fasting glucose (FPG \>= 6.1 mmol/L and \< 7 mmol/L (FPG \>= 95 mg/dL and \< 126 mg/dL) AND 2 hr PG \< 7.8 mmol/L (140 mg/dL).
Exclusion
- current use of an ACE-inhibitor (ACE-I) or thiazolidinedione(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
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT00095654
Start Date
July 1 2001
End Date
October 1 2006
Last Update
November 10 2009
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