Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Hertzel G Gerstein
ORCID ID
Contact details
McMaster University
1200 Main Street West
Room 3V38
Hamilton
L8N 3Z5
Canada
+1 905-521-2100 (73371)
gerstein@mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00095654
Protocol/serial number
MCT-41548
Study information
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)
Acronym
DREAM
Study hypothesis
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
The Research Ethics Board of McMaster University, Hamilton, Ontario gave approval on the 21st February 2001.
Study design
International multicentre randomised double-blind controlled 2 x 2 factorial trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Ramipril, rosiglitazone
Primary outcome measures
Diabetes mellitus or death (any cause) determined within 5 years.
Secondary outcome measures
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
Overall trial start date
01/10/2000
Overall trial end date
31/10/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
5000
Participant 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
Recruitment start date
01/10/2000
Recruitment end date
31/10/2006
Locations
Countries of recruitment
Canada
Trial participating centre
McMaster University
Hamilton
L8N 3Z5
Canada
Sponsor information
Organisation
McMaster University (Canada)
Sponsor details
Office of the Associate Dean
Research
McMaster University
Faculty of Health Sciences
1200 Main St. W.
Room HSC-3N8
Hamilton
L8N 3Z5
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-41548)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Sanofi-Aventis
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
King Pharmaceuticals
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Funder name
GlaxoSmithKline
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in:
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17209507
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18268075
3. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/20009095
Publication citations
-
Results
Scheen AJ, [DREAM study: prevention of type 2 diabetes with ramipril and/or rosiglitazone in persons with dysglycaemia but no cardiovascular desease]., Rev Med Liege, 2006, 61, 10, 728-732.
-
Results
, 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, 31, 5, 1007-1014, doi: 10.2337/dc07-1868.
-
Results
Hanley AJ, Zinman B, Sheridan P, Yusuf S, Gerstein HC, , Effect of Rosiglitazone and Ramipril on {beta}-cell function in people with impaired glucose tolerance or impaired fasting glucose: the DREAM trial., Diabetes Care, 2010, 33, 3, 608-613, doi: 10.2337/dc09-1579.