Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
21/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.dtu.ox.ac.uk/index.html?maindoc=/4-T/

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

http://www.mcmaster.ca/

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes