VERIFY Phase IV clinical study of vildagliptin plus metformin in type 2 diabetes published in The Lancet.- Novartis

Novartis announced the key results from the Phase IV clinical study VERIFY evaluating the long-term efficacy and safety of early combination treatment strategy with Eucras (vildagliptin) plus metformin compared to the traditional stepwise approach with metformin as initial therapy followed by vildagliptin, added at the time of metformin failure. VERIFY is a unique study designed to determine durability, over a pre-specified five-year follow-up of early use of combination therapy strategy with vildagliptin-metformin.

The study was conducted across 254 centers in 34 countries and involved 2001 treatment-na�ve diverse individuals recently diagnosed with T2DM (HbA1c between 6.5�7.5% [48�58 mmol/mol]). In the randomized, double-blind Phase IV study (ClinicalTrials.gov Identifier: NCT01528254), early combination therapy of vildagliptin (50 mg, twice daily) and metformin (individually, 1000�2000 mg, daily) met the primary endpoint with a statistically significant 49% reduction in the relative risk for time to initial treatment failure (HbA1c >= 7.0% twice, consecutively, 13 weeks apart), versus metformin alone (HR: 0.51, 95% CI [0.45, 0.58]; P<0�0001). the combination treatment strategy also showed a lower frequency of secondary failure when all patients were receiving combination therapy hr: 0.74 95 ci 0.63 0.86 p><0.0001). furthermore patients treated with early combination had consecutively lower hba1c levels below 6.0 6.5 or 7.0 for 5 years versus those receiving combination therapy only after metformin monotherapy failure.>

The overall safety and tolerability profile was similar between the treatment approaches, with no unexpected or new safety findings reported. The key study findings were presented at the European Association for the Study of Diabetes (EASD) Annual Meeting and published simultaneously in The Lancet.

See: "Glycaemic durability of an early combination therapy with vildagliptin and metformin versus sequential metformin monotherapy in newly diagnosed type 2 diabetes (VERIFY): a 5-year, multicentre, randomised, double-blind trial" David R Matthews et al. The Lancet September 18, 2019 DOI :https://doi.org/10.1016/S0140-6736(19)32131-2