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

Tracking Information

First Received Date ^ICMJE

November 5, 2004

Last Updated Date

November 9, 2009

Start Date ^ICMJE

July 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

diabetes
death

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00095654 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Myocardial infarction (MI)
Stroke
Congestive Heart Failure
Angina
Revascularization procedures
Ventricular Arrhythmia
Renal Events

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Impaired Glucose Tolerance
Cardiovascular Disease
Glucose Metabolism Disorders

Intervention ^ICMJE

Drug: Ramipril
Drug: Rosiglitazone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

5000

Completion Date

October 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00095654

Responsible Party

Study ID Numbers ^ICMJE

DREAM30Nov2002

Study Sponsor ^ICMJE

Gerstein, Hertzel, MD

Collaborators ^ICMJE

Canadian Institutes of Health Research (CIHR)
Aventis Pharmaceuticals
GlaxoSmithKline
King Pharmaceuticals
Wyeth

Investigators ^ICMJE

Principal Investigator:	Salim Yusuf, MD	McMaster University, FAX # 905-521-1166
Principal Investigator:	Hertzel Gerstein, MD	McMaster University, FAX # 905-521-4967

Information Provided By

Gerstein, Hertzel, MD

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP