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

NCT00095654 | Completed Phase 3

• 1 other identifier: DREAM30Nov2002
• Study Type: interventional
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Impaired Glucose Tolerance; Cardiovascular Disease; Glucose Metabolism Disorders

Keywords

diabetes prevention; ramipril; rosiglitazone; impaired glucose tolerance; isolated impaired fasting glucose; Isolated Impaired Glucose Tolerance

Outcome Measures

Primary Outcomes (2)

• diabetes

• death

Secondary Outcomes (7)

• Myocardial infarction (MI)

• Stroke

• Congestive Heart Failure

• Angina

• Revascularization procedures

Interventions

Ramipril DRUG

Rosiglitazone DRUG

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Gerstein, Hertzel, MD: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Aventis Pharmaceuticals: collaborator
• GlaxoSmithKline: collaborator
• King Pharmaceuticals is now a wholly owned subsidiary of Pfizer: collaborator
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Related Publications (6)

• Gerstein HC, Yusuf S, Holman R, Bosch J, Pogue J; DREAM Trial Investigators. Rationale, design and recruitment characteristics of a large, simple international trial of diabetes prevention: the DREAM trial. Diabetologia. 2004 Sep;47(9):1519-27. doi: 10.1007/s00125-004-1485-5. Epub 2004 Aug 21.

  PMID: 15322749 BACKGROUND

• 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. doi: 10.1056/NEJMoa065061. Epub 2006 Sep 15.

  PMID: 16980380 RESULT

• 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. doi: 10.1016/S0140-6736(06)69420-8.

  PMID: 16997664 RESULT

• Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.

  PMID: 38682786 DERIVED

• DREAM Trial Investigators. Incidence of diabetes following ramipril or rosiglitazone withdrawal. Diabetes Care. 2011 Jun;34(6):1265-9. doi: 10.2337/dc10-1567. Epub 2011 Apr 22.

  PMID: 21515846 DERIVED

• 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. doi: 10.2337/dc07-1868. Epub 2008 Feb 11.

  PMID: 18268075 DERIVED

MeSH Terms

Conditions

Glucose Intolerance; Cardiovascular Diseases; Glucose Metabolism Disorders

Interventions

Ramipril; Rosiglitazone

Condition Hierarchy (Ancestors)

Hyperglycemia; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Salim Yusuf, MD

  McMaster University, FAX # 905-521-1166

  PRINCIPAL INVESTIGATOR

• Hertzel Gerstein, MD

  McMaster University, FAX # 905-521-4967

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: November 5, 2004
• First Posted: November 8, 2004
• Study Start: July 1, 2001
• Study Completion: October 1, 2006
• Last Updated: November 10, 2009

Record last verified: 2009-11