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 β‐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 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/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.

What's new?

• The VERIFY study is the first study to assess the long‐term clinical benefits of early combination treatment with a dipeptidyl peptidase‐4 inhibitor (vildagliptin)‐metformin vs. standard‐of‐care metformin monotherapy in people newly diagnosed with Type 2 diabetes.

• This report describes the baseline characteristics of a newly diagnosed population with Type 2 diabetes from a diverse geographical and ethnic background, demonstrating a classic profile of presence of early insulin resistance associated with elevated BMI as a surrogate for obesity.

• The study anticipates generating unique evidence on the progression of β‐cell function, insulin resistance, early complications of diabetes, and effect on health status upon treatment with early vildagliptin‐metformin combination.