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Trial Summaries

DREAM Trial Underway

Study Purpose:
The DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) trial is a new international clinical trial to prevent type 2 diabetes mellitus. DREAM will determine if two drugs, ramipril and rosiglitazone, used alone or together can prevent the development of type 2 diabetes mellitus in patients with impaired glucose (blood sugar) tolerance. The only therapies known to reduce the risk of diabetes in individuals with impaired glucose tolerance are weight loss and exercise. No definitive trials have been done to evaluate drug prevention of diabetes mellitus. Preliminary findings suggest that ramipril and/or rosiglitazone may prevent the development of diabetes in high-risk groups.

Ramipril is a type of drug called an angiotensin converting enzyme (ACE) inhibitor that is approved for the therapy of high blood pressure and heart failure in the United States and many other countries. Recently, ramipril was proved to prevent heart attacks and strokes in high-risk people with and without high blood pressure in a study (HOPE) of more than 9,000 patients who were followed for 4.5 years. Ramipril is widely used in clinical practice and has been prescribed for several million individuals worldwide.

Rosiglitazone is a new type of drug called an “insulin sensitizer” which helps your body use the insulin it produces more effectively. It has been approved for the therapy of type 2 diabetes in the United States and many other countries, and to date more than 1.5 million patients with diabetes have been treated with rosiglitazone in the United States alone.

Study Subjects & Method of Recruitment
DREAM will enroll adults with impaired glucose tolerance, which is defined as normal fasting blood glucose with excessive blood glucose concentration (blood glucose value between 140 and 199 mg/dl) two hours after a standard 75-gram oral dose of glucose. Worldwide, about 4,000 participants will be recruited on four continents, in 20 countries, and in about 145 centers. Between 200 and 300 subjects will be recruited in the Columbia-Cornell Clinical Trials Network, many of them first-degree relatives of patients with diabetes or patients who had temporary diabetes mellitus during pregnancy. Recruitment began in August 2001 and will last about 18 months. The minimum follow-up duration will be 3 years.

Study Procedures
Individuals with increased risk of developing diabetes in the future will have a screening oral glucose tolerance test. Patients who show glucose intolerance and other entry criteria will have a few baseline tests and then be randomized to ramipril or placebo and rosiglitazone or placebo. All patients will be treated in an organized diet and exercise program. The study will last for 4.5 years. At each Follow-up visit, physical exams will be done and interval histories obtained. At approximately one half of the visits some blood work will be done (such as, liver enzymes, blood potassium, blood glucose, hemoglobin A1c, depending upon the visit). Every two years the oral glucose tolerance test will be repeated. If a participant develops diabetes mellitus, he or she will be referred promptly to his or her primary physician for treatment.

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