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Impaired Glucose TolerancePhase 3NCT00095654

The DREAM (Diabetes Reduction Assessment With Ramipril and Rosiglitazone Medication) Trial

A Phase 3 study testing Ramipril and Rosiglitazone in people with Impaired Glucose Tolerance and Cardiovascular Disease, run by Gerstein, Hertzel, MD.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if ramipril and/or rosiglitazone prevent the onset of type 2 diabetes. Read more about this study

Who is it for?
Ages 30 years and olderHealthy volunteers can take part
What is being tested?
Ramipril and Rosiglitazone
How many people
5,000 participants
Where
No sites listed yet
Study dates
Jul 2001to Oct 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • impaired glucose tolerance (FPG < 7 mmol/L or 126 mg/dL AND 2 hr PG >= 7.8 mmol/L and < 11.1 mmol/L (140 mg/dL and < 200 mg/dL)or,
  • isolated impaired fasting glucose (FPG >= 6.1 mmol/L and < 7 mmol/L (FPG >= 95 mg/dL and < 126 mg/dL) AND 2 hr PG < 7.8 mmol/L (140 mg/dL).

Who cannot join

  • current use of an ACE-inhibitor (ACE-I) or thiazolidinedione(TZD)
  • known hypersensitivity to ACE-I
  • prior use of anti-diabetic medications (with the exception of during pregnancy)
  • use of systemic glucocorticoids or niacin
  • congestive heart failure or EF < 40%
  • existing cardiovascular disease (previous MI, stroke, angina, uncontrolled hypertension)
Show all 16Show fewer
  • diabetes
  • renal or hepatic disease
  • major illness
  • use of another experimental drug
  • pregnant or unwilling to use reliable contraception
  • major psychiatric disorder
  • diseases that affect glucose tolerance
  • unwillingness to be randomized or sign informed consent
  • known uncontrolled substance abuse
  • inability to communicate with research staff

About this study

The purpose of this study is to determine if ramipril and/or rosiglitazone prevent the onset of type 2 diabetes.

Read the detailed description

The DREAM trial is a large, international, multi-centre, randomized double-blind controlled trial. A total of at least 4000 participants with impaired glucose tolerance (IGT) and 1000 participants with isolated impaired fasting glucose (IIFG) will be recruited from major international centres over an 18 month period. They will be randomly allocated to either ramipril and/or rosiglitazone using a 2X2 factorial design and followed for at least 3 years after randomization. Participants will be assessed at regular intervals to ascertain the occurrence of the primary outcome (new onset diabetes mellitus or all cause mortality) and other secondary outcomes. A diagnosis of diabetes will be made if 2 consecutive plasma glucose levels exceed the diagnostic thresholds (i.e. a fasting plasma glucose >=7.0 mmol/l (126 mg/dl) or a 2 hr plasma glucose >=11.1 mmol/l (200 mg/dl)) within a 3 month period. Assuming an annual event rate of 5%, this sample size provides 90% power to detect a 22% reduction in the rate of the primary outcome.

Potential Significance of the Study: This study could provide new strategies for the prevention of type 2 diabetes as well as provide insight into the relationship between cardiovascular disease and diabetes.

Study Update: A total of 5269 participants were enrolled into the study. 4527 Participants had IGT and 739 participants had IIFG. The study is currently in the follow-up phase.

DREAM On

In order to determine whether or not the benefits observed during the active phase of the trial are sustained after cessation of active medication use, further follow-up of the DREAM cohort will be conducted in the passive DREAM ObservatioN (DREAM On) follow-up study.

DREAM On will assess approximately 1500 consenting DREAM participants without a diagnosis of diabetes at the end of the washout phase after a post-trial period of between 1 and 2 years to determine the effect of on-trial exposure to rosiglitazone and/or exposure to ramipril on: a) the primary outcome (incident diabetes or death); and b) regression or maintenance of normoglycemia. Participants will be free to take any medications that are indicated and may participate in other research studies, according to the judgment of their own physician.

Being tested
Ramipril, Rosiglitazone
Keywords
diabetes prevention, ramipril, rosiglitazone, impaired glucose tolerance, isolated impaired fasting glucose, Isolated Impaired Glucose Tolerance
Medical subject headings
Glucose Intolerance, Cardiovascular Diseases, Glucose Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RamiprilDrug

  • RosiglitazoneDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. diabetes

  2. death

Secondary outcomes (7)

  1. Myocardial infarction (MI)

  2. Stroke

  3. Congestive Heart Failure

  4. Angina

  5. Revascularization procedures

  6. Ventricular Arrhythmia

  7. Renal Events

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2004 (estimated)
  2. Study startJul 2001
  3. Study completionOct 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Enrolment
5,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00095654
Sponsor's protocol ID
DREAM30Nov2002
Status last verified
Nov 2009
First submitted
5 Nov 2004
Last updated
10 Nov 2009
Results posted
No

Publications

  • Gerstein HC, Yusuf S, Holman R, Bosch J, Pogue J; DREAM Trial Investigators. Rationale, design and recruitment characteristics of a large, simple international trial of diabetes prevention: the DREAM trial. Diabetologia. 2004 Sep;47(9):1519-27. doi: 10.1007/s00125-004-1485-5. Epub 2004 Aug 21.

    PubMed 15322749

  • DREAM Trial Investigators; Bosch J, Yusuf S, Gerstein HC, Pogue J, Sheridan P, Dagenais G, Diaz R, Avezum A, Lanas F, Probstfield J, Fodor G, Holman RR. Effect of ramipril on the incidence of diabetes. N Engl J Med. 2006 Oct 12;355(15):1551-62. doi: 10.1056/NEJMoa065061. Epub 2006 Sep 15.

    PubMed 16980380

  • DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators; Gerstein HC, Yusuf S, Bosch J, Pogue J, Sheridan P, Dinccag N, Hanefeld M, Hoogwerf B, Laakso M, Mohan V, Shaw J, Zinman B, Holman RR. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial. Lancet. 2006 Sep 23;368(9541):1096-105. doi: 10.1016/S0140-6736(06)69420-8.

    PubMed 16997664

  • Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.

    PubMed 38682786

  • DREAM Trial Investigators. Incidence of diabetes following ramipril or rosiglitazone withdrawal. Diabetes Care. 2011 Jun;34(6):1265-9. doi: 10.2337/dc10-1567. Epub 2011 Apr 22.

    PubMed 21515846

  • DREAM Trial Investigators; 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 May;31(5):1007-14. doi: 10.2337/dc07-1868. Epub 2008 Feb 11.

    PubMed 18268075

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ramipril and Rosiglitazone in people with Impaired Glucose Tolerance and Cardiovascular Disease, run by Gerstein, Hertzel, MD.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

diabetes. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00095654, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2009.

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