completed

The objective of the DREAM ON study was 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 two-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 three 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 was assessed in the DREAM ON study.

A) Do DREAM trial participants without diabetes, who were allocated to rosiglitazone for a median of three 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 three 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)?

 

Study Type

Interventional - Drug

Study Design

Passive follow-up

NO. of Countries

9

NO. of Sites

49

NO. of Participants

1316

Study Period

2007-2008

Sponsor

PHRI

Back To Top