Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095654
Status:
COMPLETED
Last Update Posted:
2009-11-10
First Post:
2004-11-05
Brief Title:
The DREAM Diabetes Reduction Assessment With Ramipril and Rosiglitazone Medication Trial
Sponsor:
Gerstein Hertzel MD
Organization:
Gerstein Hertzel MD
Study Overview
Official Title:
The DREAM Diabetes Reduction Assessment With Ramipril and Rosiglitazone Medication Trial
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if ramipril andor 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 andor 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 ie a fasting plasma glucose 70 mmoll 126 mgdl or a 2 hr plasma glucose 111 mmoll 200 mgdl 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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None