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| [ ...Back to search results ] | [ Print-friendly version ] |
| Diabetes REduction Approaches with ramipril and rosiglitazone Medications |
| ISRCTN | ISRCTN61497824 |
| ClinicalTrials.gov identifier | NCT00095654 |
| Public title | Diabetes REduction Approaches with ramipril and rosiglitazone Medications |
| 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 |
| Serial number at source | MCT-41548 |
| 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)? |
| Lay summary | |
| 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 |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Impaired glucose tolerance (IGT) and isolated impaired fasting glucose (IFG) |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/10/2000 |
| Anticipated end date | 31/10/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 5000 |
| Interventions |
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 |
| Primary outcome measure(s) | Diabetes mellitus or death (any cause) determined within 5 years. |
| 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 |
| Sources of funding |
1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-41548)
2. Sanofi-Aventis 3. King Pharmaceuticals 4. GlaxoSmithKline |
| Trial website | http://www.dtu.ox.ac.uk/index.html?maindoc=/4-T/ |
| Publications |
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 |
| Contact name | Dr Hertzel G Gerstein |
| Address |
McMaster University
1200 Main Street West Room 3V38 |
| City/town | Hamilton |
| Zip/Postcode | L8N 3Z5 |
| Country | Canada |
| Tel | +1 905-521-2100 (73371) |
| Fax | +1 905-521-4967 |
| gerstein@mcmaster.ca | |
| Sponsor | McMaster University (Canada) |
| Address |
Office of the Associate Dean
Research McMaster University Faculty of Health Sciences 1200 Main St. W., Room HSC-3N8 |
| City/town | Hamilton |
| Zip/Postcode | L8N 3Z5 |
| Country | Canada |
| Sponsor website: | http://www.mcmaster.ca/ |
| Date applied | 26/09/2005 |
| Last edited | 21/12/2009 |
| Date ISRCTN assigned | 26/09/2005 |
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