Study of Early Combination Treatment Demonstrates Positive Results for Type 2 Diabetes

A recent clinical study demonstrated positive long-term benefits of the early intervention combination treatment of metformin plus vildagliptin (Galvus, Norvartis), a dipeptidyl peptidase-4 [DPP-4] inhibitor, for type 2 diabetes (T2D).

Novartis announced the key results from the Phase IV clinical study VERIFY today at the European Association for the Study of Diabetes (EASD) Annual Meeting. Results also were published in The Lancet.

A randomized, double-blind clinical study, VERIFY evaluated the long-term efficacy and safety of early combination treatment strategy with metformin plus vildagliptin (dipeptidyl peptidase-4 [DPP-4] inhibitor) compared to the traditional stepwise approach with metformin as initial therapy followed by vildagliptin, added at the time of metformin failure. The study sought to determine durability, over a prespecified 5-year follow-up of early use of combination therapy strategy with vildagliptin-metformin. VERIFY was conducted across 254 centers in 34 countries and involved 2001 treatment-naïve diverse individuals recently diagnosed with T2D (HbA1c between 6.5—7.5% [48–58 mmol/mol]).

In the study, 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). Additionally, 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.

Additional predefined secondary analyses of the VERIFY study results are ongoing and data will be disclosed over the coming months at international and local medical congresses and in scientific journals, according to Novartis.

Reference

Positive results from Novartis five-year VERIFY study in type 2 diabetes demonstrate long-term clinical benefits of early combination treatment with Galvus® and metformin [news release]. Basel, Switzerland; September 18, 2019: Novartis website. https://www.novartis.com/news/media-releases/positive-results-from-novartis-five-year-verify-study-type-2-diabetes-demonstrate-long-term-clinical-benefits-early-combination-treatment-galvus-and-metformin. Accessed September 18, 2019.