The primary efficacy endpoint was the time from randomisation to initial treatment failure, defined as HbA1c measurement of at least 53 mmol/mol (7·0%) at two consecutive scheduled visits, 13 weeks apart from randomisation through period 1.
According to a commentary, the VERIFY trial is the largest, long-term prospective trial testing the effects of early combination treatment on glycaemic durability, and provides reassurance that combination treatment with metformin and vildagliptin is well tolerated, safe, and effective. It notes the finding that early combination treatment reduced the probability of initial treatment failure is expected when combining medications with additive anti-hyperglycaemic effects such as metformin, which increases insulin sensitivity, and vildagliptin, which enhances β-cell function. It adds that whether early combination treatment strategy should be applied to all patients with type 2 diabetes requires further consideration. Moreover, combination treatment can potentially increase the risk of side-effects and is more costly, thus further studies are needed to confirm that early combination treatment halts the progression of diabetes, as in this study, 40% of patients on metformin monotherapy had no treatment failure within 5 years, so initiation of dual treatment at diagnosis would expose such patients to unnecessary overtreatment.