Diabetes REduction Approaches with ramipril and rosiglitazone Medications
| ISRCTN | ISRCTN61497824 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61497824 |
| ClinicalTrials.gov number | NCT00095654 |
| Secondary identifying numbers | MCT-41548 |
- 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
Scientific
McMaster University
1200 Main Street West
Room 3V38
Hamilton
L8N 3Z5
Canada
| Phone | +1 905-521-2100 (73371) |
|---|---|
| gerstein@mcmaster.ca |
Study information
| Study design | International multicentre randomised double-blind controlled 2 x 2 factorial trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ramipril, rosiglitazone |
| Primary outcome measure | 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 study start date | 01/10/2000 |
| Completion date | 31/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
L8N 3Z5
Canada
Sponsor information
McMaster University (Canada)
University/education
University/education
Office of the Associate Dean
Research
McMaster University
Faculty of Health Sciences
1200 Main St. W., Room HSC-3N8
Hamilton
L8N 3Z5
Canada
| Website | http://www.mcmaster.ca/ |
|---|---|
"ROR" |
https://ror.org/02fa3aq29 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-41548)
No information available
Sanofi-Aventis
No information available
King Pharmaceuticals
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- King Pharmaceuticals, Inc.
- Location
- United States of America
GlaxoSmithKline
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- GlaxoSmithKline plc., GSK plc., GSK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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 |
