WRITTEN BY: Todd Boudreaux
On September 18, Novartis announced results from the Phase IV VERIFY study ( V ildagliptin E fficacy in combination with metfo R m I n F or earl Y treatment of type 2 diabetes) that showed dual-combination therapy using vildagliptin and metformin at diagnosis of Type 2 diabetes led to better outcomes than treating with metformin alone.
The findings were presented at the EASD 2019 annual conference in Barcelona, Spain and published in The Lancet . For decades metformin has been the first-line treatment for T2D and other medications are typically prescribed only when monotherapy with metformin fails to adequately treat the disease. The study is the first of its kind to show that combination therapy in newly-diagnosed patients should be considered as the standard of care.
“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.
Vildagliptin (brand names Galvus and Zomelis) is an oral drug used to treat Type 2 diabetes, and belongs to the class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors. DPP-4 inhibitors work by promoting insulin secretion and decreasing the production of glucagon.
If patients did not maintain an HbA1c below 7.0% in two consecutive visits at 13-week intervals, this was considered treatment failure. Patients on metformin and placebo then received vildagliptin 50 mg twice daily in place of the placebo, while patients in the combination group continued on with their combination therapy. Those receiving the combination therapy from the start were 50% less likely to lose blood sugar control than those on metformin alone.
And during the second phase of the trial when patients in both groups could be receiving combination therapy, the risk of losing blood sugar control (going above HbA1c 7.0% twice) was reduced by 26% among those who began on combination therapy, compared to those who transferred after metformin monotherapy treatment failed. This last statistic is perhaps the most significant, demonstrating that starting on combination therapy can have lasting effects and better outcomes than shifting to combination therapy only after loss of blood sugar control (as defined by the study).
“Despite Type 2 diabetes having become an epidemic with growing mortality and morbidity rates, there is a distinct lack of optimized management strategies at diagnosis that can induce durability and slow down disease progression,” said Marcia Kayath, Global Head Medical Affairs and Chief Medical Officer, Novartis Pharmaceuticals. “These promising results from the VERIFY study have the potential to improve patient outcomes and the way in which we treat type 2 diabetes in the future”.
Additional analysis of the VERIFY study is ongoing, and more data will be disclosed in journals and at conferences over the coming months.