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 metformin plus vildagliptin (dipeptidyl peptidase-4 [DPP-4] inhibitor).
The treatment was compared to the traditional stepwise approach with metformin as initial therapy followed by vildagliptin, added at the time of metformin failure.
In the Phase IV 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). 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 initial findings from the VERIFY study uniquely demonstrate that early intervention with a combination therapy strategy provides greater and durable long-term benefits for patients. The currently recommended initial monotherapy approach with later treatment intensification in type 2 diabetes management is now shown to be an inferior strategy,” said Professor David Matthews, EASD President and Emeritus Professor of Diabetic Medicine, University of Oxford, UK.
The overall safety and tolerability profile were similar between the treatment approaches, with no unexpected or new safety findings reported.