1. Early combination therapy with vildagliptin and metformin is associated with improved glycemic durability in the setting of newly diagnosed type 2 diabetes.
Evidence Rating Level: 1 (Excellent)
Early glycemic control in type 2 diabetes is associated with glycemic durability and a reduced risk of developing related complications. The early introduction of combination therapy with two or more agents may achieve early, optimized glycemic control. Despite some support for early combination therapy for greater reduction in hemoglobin A1C (HbA1C) compared to metformin monotherapy, there is limited evidence to support the early initiation of such a strategy for maintaining glycemic control. The Vildagliptin Efficacy in combination with metfoRmIn For earlY treatment of type 2 diabetes (VERIFY) study, a randomized double-blind trial, compared early combination therapy with metformin (stable daily dose of 1000 mg, 1500 mg, or 2000 mg) and dipeptidyl peptidase-4 inhibitor vildagliptin 50 mg twice daily with metformin monotherapy and placebo. If the initial treatment did not allow for the maintenance of a HbA1C level below 7.0%, patients in the monotherapy group received vildagliptin twice daily instead of placebo as part of study period 2. The primary endpoint was time from randomization to initial treatment failure, defined as an HbA1C of at least 7.0% on two consecutive visits, 13 weeks apart. Overall, 81.3% and 78.5% of early combination therapy and metformin monotherapy patients completed the 5-year study, respectively. Researchers found that the incidence of initial treatment failure in the first study period was 43.6% and 62.1% in the combination and monotherapy groups, respectively. The median time to treatment failure was also significantly decreased in the combination group at 61.9 months (IQR 29.9 months – not reached) compared to the monotherapy group at 36.1 months (IQR 15.3 months – not reached) (HR 0.51, 95% CI 0.45 to 0.58, p<0.0001). Both treatments were well-tolerated, with minimal safety issues and no treatment-related mortality events. The findings of this study therefore suggest that early combination therapy with vildagliptin and metformin provides more substantial and long-standing glycemic control compared to current standard of care with metformin monotherapy for newly diagnosed type 2 diabetes mellitus.
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