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

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gerstein, Hertzel, MD
• Collaborators: Aventis Pharmaceuticals; Canadian Institutes of Health Research (CIHR); GlaxoSmithKline; King Pharmaceuticals is now a wholly owned subsidiary of Pfizer; Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Ramipril; Rosiglitazone

Criteria

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)

• 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