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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
Author(s) -
Matthews D. R.,
Paldánius P. M.,
Proot P.,
Foley J. E.,
Stumvoll M.,
Del Prato S.
Publication year - 2019
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/dme.13886
Subject(s) - medicine , interquartile range , vildagliptin , metformin , insulin , type 2 diabetes , population , diabetes mellitus , endocrinology , glucose homeostasis , gastroenterology , insulin resistance , environmental health
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.