The DREAM (Diabetes Reduction Assessment With Ramipril and Rosiglitazone Medication) Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 5,000
- Primary Endpoint
- diabetes
Study Overview
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 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.
Study Update: A total of 5269 participants were enrolled into the study. 4527 Participants had IGT and 739 participants had IIFG. The study is currently in the follow-up phase.
DREAM On
In order to determine whether or not the benefits observed during the active phase of the trial are sustained after cessation of active medication use, further follow-up of the DREAM cohort will be conducted in the passive DREAM ObservatioN (DREAM On) follow-up study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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)
- •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
Outcomes
Primary Outcomes
diabetes
death
Secondary Outcomes
- Congestive Heart Failure
- Revascularization procedures
- Myocardial infarction (MI)
- Stroke
- Renal Events
- Angina
- Ventricular Arrhythmia