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Research

Photo for DREAM On

DREAM On

Official Title

Diabetes REduction Assessment with ramipril and rosiglitazone Medication Ongoing evaluatioN

Status

Completed

Overview

To show that rosiglitazone substantially reduced the risk of diabetes and increased regression to normoglycemia in people with either impaired fasting glucose and/or impaired glucose tolerance. The 2 month washout suggested that there was durability of this effect after stopping rosiglitazone; however this may have been influenced by the long half-life of rosiglitazone. Clear evidence within the DREAM trial that rosiglitazone increased hip circumference and reduced the waist/hip ratio and ALT levels, and animal data suggesting that rosiglitazone may preserve beta cell mass and function suggests that the median 3 years of exposure to rosiglitazone in DREAM may have an even longer-term effect on the prevention of diabetes and its consequences. Such an effect would be detectable by further open follow-up of the DREAM cohort and will be assessed in the passive DREAM ON follow-up study. The DREAM trial also showed that ramipril clearly increased regression to normoglycemia by 17%, and reported a nonsignificant 9% reduction in diabetes incidence. Whether or not the effect on regression means that longer treatment and follow-up would detect an effect on diabetes prevention remains unknown. This possibility will also be assessed in the DREAM ON study.

Study Design

Passive follow-up

Primary Endpoint

a) Do DREAM trial participants without diabetes who were allocated to rosiglitazone for a median of 3 years during the active treatment phase have a significantly lower incidence of the primary outcome of diabetes or death compared to the group allocated to placebo (regardless of subsequent therapy) during the full follow-up period (i.e. the active treatment phase plus the passive observation phase)?

b) Do DREAM trial participants without diabetes who were allocated to ramipril for a median of 3 years during the active treatment phase have a significantly lower incidence of the primary outcome of diabetes or death compared to the group allocated to placebo (regardless of subsequent therapy) during the full follow-up period (i.e. the active treatment phase plus the passive observation phase)?

Number of Patients

1361

Number of Sites

49

Number of Countries

9

Study Period

2007–2008

Principal Investigator

Hertzel Gerstein

Program Manager

Jackie Bosch

Research Coordinator

Laura Joldersma

Collaborators

GSK, Aventis

Key Publications

  • DREAM On (Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication Ongoing Follow-up) Investigators, Gerstein HC, Mohan V, Avezum A, Bergenstal RM, Chiasson JL, Garrido M, MacKinnon I, Rao PV, Zinman B, Jung H, Joldersma L, Bosch J, Yusuf S. Long-term effect of rosiglitazone and/or ramipril on the incidence of diabetes. Diabetologia. 2011 Mar;54(3):487-95. doi: 10.1007/s00125-010-1985-4.