NCT00095654

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,000 (planned)
• Sponsor: Gerstein, Hertzel, MD · Individual
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

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. DREAM On will assess approximately 1500 consenting DREAM participants without a diagnosis of diabetes at the end of the washout phase after a post-trial period of between 1 and 2 years to determine the effect of on-trial exposure to rosiglitazone and/or exposure to ramipril on: a) the primary outcome (incident diabetes or death); and b) regression or maintenance of normoglycemia. Participants will be free to take any medications that are indicated and may participate in other research studies, according to the judgment of their own physician.

Conditions

• Impaired Glucose Tolerance
• Cardiovascular Disease
• Glucose Metabolism Disorders

Interventions

Type	Name	Description
DRUG	Ramipril
DRUG	Rosiglitazone

Timeline

• Start date: 2001-07-01
• Completion: 2006-10-01
• First posted: 2004-11-08
• Last updated: 2009-11-10