Early Diabetes Intervention Trial (EDIT)
EDIT is a six-year, prospective, randomized, placebo-controlled study in subjects with two consecutive fasting plasma glucose levels in the range 5.5-7.7 mmol/L (100-139 mg/dl). Nine UK clinical centers have recruited 631 subjects. The primary aim of the trial is to determine whether deterioration in glycemic tolerance towards diabetes can be delayed or prevented using the alpha-glucosidase inhibitor acarbose or the biguanide metformin, in a 2 x 2 factorial design. Three-year interim results have been presented in abstract form200. No significant effect has yet been seen on diabetes incidence, though both drug groups were said to have lower rates than the placebo group, but data were not presented for comparison. Small improvements in insulin sensitivity and beta-cell function, triglyceride levels and glucose levels were seen in both groups. Weight, HbA1c and lipid profiles were not improved. The study will continue for three more years.
The NEPI ANtidiabetes StudY (NANSY)
The Network for Pharmacoepidemiology in Scandinavia is beginning a random-ized-placebo controlled study of the sulfonylurea glimepiride (Amaryl) at a dose of 1 mg a day among persons with IGT271. Subjects will be men and women of European ancestry living in Sweden and Norway who are 40-70 years of age with an initial fasting blood glucose >5.6 mmol/l (100 mg/dl) and the mean of initial and subsequent tests >5.6 and <6.1 mmol/l (whole blood, <110 mg/dl) . All participants will receive initial advice about diet and physical activity, although no special lifestyle program is included. Randomization began in February 2000 and recruitment will last about two years. Participants will be followed for five years or until diabetes develops, when they will be placed on open label glimepiride. It is planned that 1112 participants per group (2224 total) will be enrolled, which will allow the detection of a 33% reduction in diabetes incidence. Results are expected in 2007.
Diabetes REduction Assessment with Ramipril and Rosiglitazone Medication (DREAM)
The DREAM trial is an international, multicenter, double-blind RCT aimed at recruiting at least 4000 participants with IGT. Participants will be randomly allocated to either ramipril and/or rosiglitazone using a 2 x 2 factorial design and followed for at least three years. Ramipril, an ACE-I, was suggested to reduce diabetes incidence in the Heart Outcomes Prevention Evaluation (HOPE) Study225 in a subset analysis. DREAM will attempt to replicate these findings in a more homogeneous subset of subjects with IGT. The use of rosiglitazone, a second-generation thiazolidinedione insulin-sensitizing agent, is predicated on the positive preliminary results using troglitazone reviewed previously. Randomization began in 2000 and the trial will follow subjects for three years after randomization.
Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research (Navigator)
The Navigator Trial is industry-sponsored and will test the prevention of type 2 diabetes using two novel agents in a 2 x 2 factorial design with placebo. Nateglinide is an amino acid derivative that reduces post-prandial glycemia when taken immediately before meals272. Valsartan is an angiotensin-II receptor blocker, indicated for high blood pressure and heart failure273. The goal is to determine whether restoration of early phase insulin secretion and improvements in insulin sensitivity can arrest decline to type 2 diabetes and prevent cardiovascular disease. The study will be conducted in 600-800 centers in 30 countries, and will recruit 7500 subjects who have IGT and either a history of cardiovascular disease (if aged 50 or older) or one or more cardiovascular risk factors (if aged 55 or older). Diabetes incidence will be examined at three years (phase 1) and CVD prevention at five or six years (phase 2). Recruitment began in 2001 and the trial is expected to continue until 2006-2007.
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Diabetes is a disease that affects the way your body uses food. Normally, your body converts sugars, starches and other foods into a form of sugar called glucose. Your body uses glucose for fuel. The cells receive the glucose through the bloodstream. They then use insulin a hormone made by the pancreas to absorb the glucose, convert it into energy, and either use it or store it for later use. Learn more...