Overview

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