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

NCT00095654

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Impaired Glucose Tolerance, Cardiovascular Disease, Glucose Metabolism Disorders
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)


- 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

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Impaired Glucose Tolerance, Cardiovascular Disease, Glucose Metabolism DisordersThe DREAM (Diabetes Reduction Assessment With Ramipril and Rosiglitazone Medication) Trial
NCT00095654
ALL GENDERS
30 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The DREAM (Diabetes Reduction Assessment With Ramipril and Rosiglitazone Medication) Trial
Official Title  ICMJE The DREAM (Diabetes Reduction Assessment With Ramipril and Rosiglitazone Medication) Trial
Brief Summary The purpose of this study is to determine if ramipril and/or rosiglitazone prevent the onset of type 2 diabetes.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Impaired Glucose Tolerance
  • Cardiovascular Disease
  • Glucose Metabolism Disorders
Intervention  ICMJE
  • Drug: Ramipril
  • Drug: Rosiglitazone
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
5000
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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)
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00095654
Other Study ID Numbers  ICMJE DREAM30Nov2002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Gerstein, Hertzel, MD
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Aventis Pharmaceuticals
  • GlaxoSmithKline
  • King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
  • Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Salim Yusuf, MDMcMaster University, FAX # 905-521-1166
Principal Investigator:Hertzel Gerstein, MDMcMaster University, FAX # 905-521-4967
PRS Account Gerstein, Hertzel, MD
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP