Diabetes REduction Approaches with ramipril and rosiglitazone Medications

ISRCTN	ISRCTN61497824
DOI	https://doi.org/10.1186/ISRCTN61497824
ClinicalTrials.gov (NCT)	NCT00095654
Protocol serial number	MCT-41548
Sponsor	McMaster University (Canada)
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-41548), Sanofi-Aventis, King Pharmaceuticals, GlaxoSmithKline

Submission date: 26/09/2005
Registration date: 26/09/2005
Last edited: 21/12/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Hertzel G Gerstein
Scientific

McMaster University
1200 Main Street West
Room 3V38
Hamilton
L8N 3Z5
Canada

Phone	+1 905-521-2100 (73371)
Email	gerstein@mcmaster.ca

Study information

Primary study design	Interventional
Study design	International multicentre randomised double-blind controlled 2 x 2 factorial trial
Secondary study design	Randomised controlled trial
Scientific title	A large, international, multi-centre, randomised double-blind controlled trial designed to determine if treatment with either ramipril and/or rosiglitazone will prevent or reduce the incidence of diabetes in people with impaired glucose tolerance (IGT) or impaired fasting glucose (IFG)
Study acronym	DREAM
Study objectives	Does the addition of either ramipril (up to 15 mg/day) or rosiglitazone (8 mg/day) prevent the composite outcome of either type 2 diabetes or all-cause mortality in non-diabetic people with impaired glucose tolerance (IGT) or impaired fasting glucose (IFG)?
Ethics approval(s)	The Research Ethics Board of McMaster University, Hamilton, Ontario gave approval on the 21st February 2001.
Health condition(s) or problem(s) studied	Impaired glucose tolerance (IGT) and isolated impaired fasting glucose (IFG)
Intervention	Group 1: ramipril titrated to 15 mg/day or highest tolerated dose for a minimum of 3 and up to 5 years Group 2: placebo titrated to 15 mg/day or highest tolerated dose for a minimum of 3 and up to 5 years Group 3: rosiglitazone titrated to 8 mg Group 4: placebo titrated to 8 mg Trial details received: 12 Sept 2005
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Ramipril, rosiglitazone
Primary outcome measure(s)	Diabetes mellitus or death (any cause) determined within 5 years.
Key secondary outcome measure(s)	1. Q wave MI 2. Non-Q wave MI 3. MI and no electrocardiogram (ECG) change 4. Ischaemic stroke 5. Haemorrhagic stroke 6. Uncertain stroke 7. Cardiovascular (CV) death 8. Heart failure 9. CV revascularisation 10. Angina 11. Ventricular tachyarrhythmia 12. Creatinine clearance 13. Albuminuria progression determined within 5 years
Completion date	31/10/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	5000
Key inclusion criteria	1. Women and men of any ethnic background and age greater than or equal to 30 years 2. A fasting plasma glucose value less than 7 mmol/l and a two-hour plasma glucose 7.8 - 11.0 mmol/l after a 75 g oral glucose tolerance test (OGTT) or fasting plasma glucose 6.1 - 6.9 mmol/l and a two-hour plasma glucose less than 7.8 mmol/l
Key exclusion criteria	1. Current use of an angiotensive converting enzyme (ACE) inhibitor, thiazolidinedione 2. Known hypersensitivity to ACE inhibitors or use of systemic glucocorticoids or niacin 3. Cardiovascular disease (previous myocardial infarction (MI), stroke, angina, congestive heart failure or previous coronary or peripheral angioplasty or bypass, or uncontrolled hypertension) 4. Previous diagnosis of diabetes, renal or hepatic disease, disease that affects glucose tolerance or major psychiatric disorder
Date of first enrolment	01/10/2000
Date of final enrolment	31/10/2006

Locations

Countries of recruitment

Canada

Study participating centre

McMaster University

Hamilton
L8N 3Z5
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2006		Yes	No
Results article	results	01/05/2008		Yes	No
Results article	results	01/03/2010		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes