Novartis’s 5 year long clinical study on type 2 diabetes treatment gets positive results

Early combination treatment strategy with vildagliptin and metformin was superior to the standard of care in newly diagnosed type 2 diabetes patients. The landmark VERIFY study is the first to investigate the long-term clinical benefits of this early combination strategy in type 2 diabetes

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Mumbai: The leading pharma major, Novartis has 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 study compared it to the traditional stepwise approach with metformin as initial therapy followed by vildagliptin, added at the time of metformin failure.

The key study findings were presented at the European Association for the Study of Diabetes (EASD) Annual Meeting and published simultaneously in The Lancet.

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-naïve 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)1,2.

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 failure1.

“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 was similar between the treatment approaches, with no unexpected or new safety findings reported1.

“In light of the existing gaps in diabetes management in India which is home to over 72 million people living with diabetes, we continue to focus on driving science in order to improve patient outcomes. The VERIFY study is an extension of our efforts towards continuing to win for as many patients with diabetes. The positive results from the VERIFY study further affirm the importance of early treatment intensification in newly diagnosed type 2 diabetes patients,” said Sanjay Murdeshwar, Managing Director, Novartis in India.

Additional pre-defined 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.