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

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Aventis Pharmaceuticals
GlaxoSmithKline
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Gerstein, Hertzel, MD
ClinicalTrials.gov Identifier:
NCT00095654
First received: November 5, 2004
Last updated: November 9, 2009
Last verified: November 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: The DREAM (Diabetes Reduction Assessment With Ramipril and Rosiglitazone Medication) Trial

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00095654     History of Changes
Other Study ID Numbers: DREAM30Nov2002
Study First Received: November 5, 2004
Last Updated: November 9, 2009
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:
Cardiovascular Diseases
Glucose Intolerance
Metabolic Diseases
Glucose Metabolism Disorders
Hyperglycemia
Ramipril
Rosiglitazone
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014