19 September 2019 | News
The overall safety and tolerability profile was similar between the treatment approaches, with no unexpected or new safety findings reported
Early combination treatment strategy with vildagliptin and metformin was superior to standard of care in newly diagnosed type 2 diabetes patients
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) compared 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 today 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]).
Professor David Matthews, EASD President and Emeritus Professor of Diabetic Medicine, University of Oxford, UK said, “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.”
The overall safety and tolerability profile was similar between the treatment approaches, with no unexpected or new safety findings reported.
Sanjay Murdeshwar, Managing Director, Novartis in India said, “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.”
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.