Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication

Co-chairs:Hertzel Gerstein
Salim Yusuf

European co-chair: Rury Holman

Reference number:NCT00095654

The Diabetes REduction Assessment with ramipril and rosiglitazone Medication (DREAM) study is a large-scale, international, multi-centre, randomised, double-blind, controlled, 2x2 factorial design trial which aims to determine if treatment with an ACE inhibitor (ramipril) and/or a thiazolidinedione (rosiglitazone) can delay or prevent the development of type 2 diabetes (T2DM) in people with impaired glucose tolerance (IGT) or impaired fasting glucose (IFG). Recruitment commenced in July 2001 and ended in August 2003. A total of 5269 patients (4531 IGT and 738 IFG) have been recruited and will be followed for a minimum of three years with regular assessment to ascertain the occurrence of the primary outcome (new onset T2DM or all cause mortality) as well as predefined secondary outcomes. The study is co-ordinated by the Canadian Cardiovascular Collaboration (CCC) at McMaster University, Hamilton, Canada. European sites are managed by the EuroDREAM project office (see contact details below) at the Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, Oxford, UK

Results

DREAM shows drug therapy can prevent diabetes

The results of the trial were presented on Friday 15th September 2006 in Copenhagen, at the 42nd Annual Meeting of the European Association for the Study of Diabetes (EASD).

The international DREAM trial showed that a drug used to treat diabetes may significantly reduce the chances of developing the condition when taken by those most at risk.

This trial, involving 5,269 participants from 191 clinics in 21 countries, showed that taking the drug rosiglitazone reduced the chance of getting type 2 diabetes by 60 per cent among those at high risk.

The trial was co-ordinated by the Diabetes Trials Unit at Oxford University and the Canadian Cardiovascular Collaboration at McMaster University, Canada. The results have major implications for future health care.

The study included 5,269 people worldwide whose average age was 55 and whose glucose level was starting to rise but who did not have diabetes. Participants took rosiglitazone (a thiazolidinedione), ramipril (an angiotensin-converting enzyme inhibitor), or a placebo over a period of three years.

Among study participants taking rosiglitazone, only 12 per cent developed diabetes, compared to 26 percent who were taking the placebo. Rosiglitazone also normalized glucose levels in 51 percent of participants versus 30 percent of those taking a placebo. It benefited all participants, and particularly those who weighed the most.

Rosiglitazone is a thiazolidinedione drug that is currently used to treat diabetes. It works by helping the body respond to its own insulin and may also preserve the ability to make insulin. 

Ramipril, the other drug trialled, did not reduce the risk of diabetes, which affected 18 percent of participants on that drug and 20 percent on placebo. However, significantly more people taking ramipril (43 percent) than the placebo (38 percent) had normal glucose levels by the end of the study.

Type 2 diabetes develops when the body can no longer produce sufficient insulin to meet demand, often in people where insulin already works less well than normal (known as insulin resistance). Rising glucose levels, as seen in all the participants of the trial, are a warning sign. Type 2 diabetes is the more common of the two main types and accounts for 85–95 per cent of all people with diabetes. It is strongly associated with being overweight. More than five percent of all adults have a diagnosis of type 2 diabetes, and this rate is rising rapidly throughout the world, due in part to the increase in weight and reduction in physical activity in both developed and developing countries.

Those with type 2 diabetes require lifelong therapy to reduce their high risk of further complications such as blindness, kidney failure, amputations, heart attacks, strokes and premature death.

The European co-chair of the study was Professor Rury Holman, Director of the Diabetes Trial Unit within the Oxford Centre for Diabetes, Endocrinology and Metabolism (OCDEM), a clinical centre for diabetes research with Oxford University. He said: 'Preventing diabetes is far better than simply controlling it - especially considering the high risk of serious secondary health problems and the high cost of treating diabetes. Although modest dietary and physical activity changes can prevent type 2 diabetes in many people, additional strategies for high-risk individuals are also needed urgently. Our findings about rosiglitazone provide another opportunity to help tackle this growing health problem.'

The rosiglitazone results will be published in medical journal The Lancet. The ramipril results will be published in the New England Journal of Medicine.