Baseline characteristics in the VERIFY study: a randomized trial assessing the durability of glycaemic control with early vildagliptin-metformin combination in newly diagnosed Type 2 diabetes.

Abstract

AimTo assess the long‐term clinical benefits of early combination treatment with vildagliptin‐metformin vs. standard‐of‐care, metformin monotherapy in the ongoing VERIFY study.MethodsWe randomized 2001 participants with multi‐ethnic background, aged 18–70 years, having HbA1c levels 48–58 mmol/mol (6.5–7.5%) and BMI 22–40 kg/m2. Baseline data included HbA1c, fasting plasma glucose and homeostasis model β‐cell and insulin sensitivity. Standardized meal‐tests, insulin secretion rate relative to glucose, and oral glucose insulin sensitivity were assessed in a subpopulation.ResultsOut of 4524 screened, data were collected from the 2001 eligible participants (53% women) across Europe (52.4%), Latin America (26.8%), Asia (17.2%), South Africa (3.1%) and Australia (0.5%). The median (interquartile range) disease duration was 3.4 (0.9, 10.2) months; mean (±SD) age 54.3±9.4 years; weight 85.5±17.5 kg and BMI 31.1±4.7 kg/m2. Baseline HbA1c was 52±3 mmol/mol (6.9±0.3%), fasting plasma glucose 7.5±1.5 mmol/l and the median (interquartile range) of fasting insulin was 109 (75–160) mU/l. Homeostasis model β‐cell and insulin sensitivity values were 84% (60, 116) and 46% (31, 68), respectively. In those undertaking meal‐tests, insulin secretion rate relative to glucose was 28±12 pmol/min/m2/mmol/l and oral glucose insulin sensitivity was 353±57 ml/min/m2.ConclusionsOur current, multi‐ethnic, newly diagnosed VERIFY population reflects a characteristic presence of early insulin resistance in participants with increased demand for insulin associated with obesity. The VERIFY study will provide unique evidence in characterizing therapeutic intervention in a diverse population with hyperglycaemia, focusing on durability of early glycaemic control.