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

Aim To assess the long-term clinical benefits of early combination treatment with vildagliptin-metformin vs. standard-of-care, metformin monotherapy in the ongoing VERIFY study. Methods We randomized 2001 participants with multi-ethnic background, aged 18-70 years, having HbA(1c) levels 48-58 mmol/mol (6.5-7.5%) and BMI 22-40 kg/m(2). Baseline data included HbA(1c), fasting plasma glucose and homeostasis model beta-cell and insulin sensitivity. Standardized meal-tests, insulin secretion rate relative to glucose, and oral glucose insulin sensitivity were assessed in a subpopulation. Results Out 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/m(2). Baseline HbA(1c) 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 beta-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/m(2)/mmol/l and oral glucose insulin sensitivity was 353 +/- 57 ml/min/m(2). Conclusions Our 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.