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

Condition(s) targeted: Impaired Glucose Tolerance; Cardiovascular Disease; Glucose Metabolism Disorders

Intervention: Ramipril (Drug); Rosiglitazone (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Gerstein, Hertzel, MD

Official(s) and/or principal investigator(s):
Salim Yusuf, MD, Principal Investigator, Affiliation: McMaster University, FAX # 905-521-1166
Hertzel Gerstein, MD, Principal Investigator, Affiliation: McMaster University, FAX # 905-521-4967

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

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

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

Primary outcome:

diabetes

death

Secondary outcome:

Myocardial infarction (MI)

Stroke

Congestive Heart Failure

Angina

Revascularization procedures

Ventricular Arrhythmia

Renal Events

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.

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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

Related publications:

[No authors listed] Rationale, design and recruitment characteristics of a large, simple international trial of diabetes prevention: the DREAM trial. Diabetologia. 2004 Aug 21 [Epub ahead of print]

Starting date: July 2001
Ending date: October 2006
Last updated: November 29, 2006