Early Prevention of Diabetes Complications in people with Hyperglycaemia in Europe
Coordinator: Jaakko TUOMILEHTO
Project Number: 279074
EC contribution: € 5,999,996,00
Project website: http://www.epredice.eu/
The current approach of T2D treatment only uses the most efficacious agents after the failure of the less effective ones.
Aims: to investigate the efficacy of an early, intensive and multifactorial treatment for the prevention of diabetic complications in people with hyperglycemia currently under lifestyle intervention. To investigate if it is possible to detect groups at higher risk of developing complications at an earlier stage and, up to what extent, more intensive treatment could be prioritized to such a group.
Study Population: Patients 45 to 74 years old with hyperglycaemia (fasting blood glucose>100 mg/dl or 2h postchallenge blood glucose>140 mg/dl) and without clinical evidence of microvacular or macrovascular complications at the time of recruitment (n=3008).
Methods: Multicentre, randomised, controlled (four parallel groups), open-label, phase-3b, clinical trial with prospective blinded outcome evaluation (PROBE)
Interventions: Standard lifestyle intervention, metformin 1000mg/day, Vildagliptin 100mg/day and Liraglutide 1.2 mg/day. First phase: 3-month run-in period to evaluate drug tolerability. Second phase: treatment and follow-up during 36 months. Endpoints: retinal changes and progression of diabetic retinopathy; renal function impairment, microalbuminuria and albumin/creatinin ratio; cardiovascular autonomic neuropathy and diabetic autonomous neuropathy. A combined endpoint (score 0-4), of the single endpoints.
Expected results: To show whether early intensive multifactorial pharmacotherapy targeting glycaemia can help in reaching the key indicators of good diabetes care. To characterize for the first time those individuals who will develop early complications. To identify which complication appear in the first place and the cumulative frequency of various complications. To provide data on cost-effectiveness to guide clinical decisions.To explore new screening and diagnostic technologies to be included in usual clinical practice