Early Prevention of Diabetes Complications in people with Hyperglycaemia in Europe

To assess the effect of treatment with sitagliptine, metformin or the combination of sitagliptin with metformin, plus lifestyle intervention (diet and exercise), compared to lifestyle intervention alone, for at least 3 years, and up to 5 years, on different microvascular parameters (retinal, renal and neurological), as defined by the primary and secondary endpoints, in adults with non-diabetic hyperglycaemia (IGT, IFG or IFG plus IGT). Secondary objectives are: to identify among people with hyperglycaemia who are most likely to develop early diabetic complication; to find out which of the early diabetic complications can be best prevented by interventions applied in this study; to determine the extent to which the compliance to the interventions affect the rate of early diabetic complications; to evaluate the effects of the different regimes applied in this study on quality of life and neuropsychological functions; to assess the efficacy of treatment with sitagliptine, metformin or the combination of sitagliptin with metformin plus lifestyle interventions in comparison to lifestyle intervention alone with regard to surrogate parameters of vascular function and structure, and novel biomarkers of microvascular damage in adults with non-diabetic hyperglycaemia (IGT, IFG or IFG plus IGT); to determine the safety of, sitagliptine metformin and the combination of sitagliptin with metformin plus lifestyle intervention in adults with non-diabetic hyperglycaemia (IGT, IFG or IFG plus IGT) with regard to severe adverse effects and clinically important events. The study design is a multicentre, randomised, controlled (four parallel groups), open-label, phase-3b, clinical trial with prospective blinded outcome evaluation (PROBE). Group 1: Lifestyle intervention + two placebo tablets a day Group 2: Lifestyle intervention + two Metformin tablet 850 mg per day Group 3:Lifestyle intervention + two tablets of Sitagliptin 50 mg a day Group 4: Lifestyle intervention + two tablets of a fixed-dose combination of Sitagliptin 50mg with Metformin 850mg a day