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

Sponsor:	Gerstein, Hertzel, MD
Collaborators:	Canadian Institutes of Health Research (CIHR) Aventis Pharmaceuticals GlaxoSmithKline King Pharmaceuticals Wyeth
Information provided by:	Gerstein, Hertzel, MD
ClinicalTrials.gov Identifier:	NCT00095654

Purpose

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

Condition	Intervention	Phase
Impaired Glucose Tolerance Cardiovascular Disease Glucose Metabolism Disorders	Drug: Ramipril Drug: Rosiglitazone	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	The DREAM (Diabetes Reduction Assessment With Ramipril and Rosiglitazone Medication) Trial

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Metabolic Disorders

Drug Information available for: Ramipril Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by Gerstein, Hertzel, MD:

Primary Outcome Measures:

diabetes
death

Secondary Outcome Measures:

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

Estimated Enrollment:	5000
Study Start Date:	July 2001
Study Completion Date:	October 2006

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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095654

Sponsors and Collaborators

Gerstein, Hertzel, MD

Canadian Institutes of Health Research (CIHR)

Aventis Pharmaceuticals

GlaxoSmithKline

King Pharmaceuticals

Wyeth

Investigators

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

More Information

Publications:

DREAM Trial Investigators; Bosch J, Yusuf S, Gerstein HC, Pogue J, Sheridan P, Dagenais G, Diaz R, Avezum A, Lanas F, Probstfield J, Fodor G, Holman RR. Effect of ramipril on the incidence of diabetes. N Engl J Med. 2006 Oct 12;355(15):1551-62. Epub 2006 Sep 15.

DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators; Gerstein HC, Yusuf S, Bosch J, Pogue J, Sheridan P, Dinccag N, Hanefeld M, Hoogwerf B, Laakso M, Mohan V, Shaw J, Zinman B, Holman RR. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial. Lancet. 2006 Sep 23;368(9541):1096-105.

[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]

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

DREAM Trial Investigators; Dagenais GR, Gerstein HC, Holman R, Budaj A, Escalante A, Hedner T, Keltai M, Lonn E, McFarlane S, McQueen M, Teo K, Sheridan P, Bosch J, Pogue J, Yusuf S. Effects of ramipril and rosiglitazone on cardiovascular and renal outcomes in people with impaired glucose tolerance or impaired fasting glucose: results of the Diabetes REduction Assessment with ramipril and rosiglitazone Medication (DREAM) trial. Diabetes Care. 2008 May;31(5):1007-14. Epub 2008 Feb 11.

Study ID Numbers:	DREAM30Nov2002
Study First Received:	November 5, 2004
Last Updated:	November 9, 2009
ClinicalTrials.gov Identifier:	NCT00095654 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Gerstein, Hertzel, MD:

diabetes prevention
ramipril
rosiglitazone

impaired glucose tolerance
isolated impaired fasting glucose
Isolated Impaired Glucose Tolerance

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Glucose Intolerance
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Ramipril
Pharmacologic Actions

Protease Inhibitors
Hypoglycemic Agents
Hyperglycemia
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Glucose Metabolism Disorders
Rosiglitazone

ClinicalTrials.gov processed this record on November 20, 2009