A new study found that early intervention with a combination therapy of vildagliptin plus metformin provides greater and durable long-term benefits compared with the current initial metformin monotherapy for patients with newly diagnosed type 2 diabetes.
This was the initial key finding of Verify, 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 2,001 diverse individuals recently diagnosed with type 2 diabetes whose HbA1c (hemoglobin A1c) ranged between 7.5 and 6.5 and who had not yet been prescribed treatment.
“We all know that early treatment intensification to achieve good blood glucose control is crucial to delaying diabetic complications. What we’re not yet certain was whether early combination therapy would be more beneficial than an ad hoc sequential process starting with metformin monotherapy, knowing that the majority of type 2 diabetes patients over a period of three years are going to experience treatment failure,” said Professor Merlin Thomas, endocrinologist and kidney specialist at the Department of Diabetes of Monash University in Melbourne, Australia
“Not anymore. Verify clearly shows that investing in early combination therapy pays big dividends in terms of less treatment failures over the long term,” added Thomas.
According to one of the study directors, Dr. Päivi Paldánius, “Previous studies on type 2 diabetes have been repeating the same pattern, and not really focusing on the clinically relevant questions and clinical situations that doctors face.”
“With Verify,” the Novartis Worldwide brand medical director for diabetes said, “we are finally asking the right questions and getting marvelous answers.”
Verify showed that early combination therapy of vildagliptin (50 mg, twice daily) and metformin (individually, 1000-2000 mg, daily) resulted in a statistically significant 49 percent reduction in the relative risk for time to initial treatment failure, versus metformin alone.
Treatment failure is defined as HbA1c of 7 percent or higher, twice consecutively, 13 weeks apart. The combination treatment strategy also showed a lower frequency of secondary failure when all patients were receiving combination therapy.
Furthermore, patients treated with the early combination had consecutively lower HbA1c levels (below 6, 6.5, or 7 percent) for five years versus those receiving combination therapy only after metformin monotherapy failure.
The major strength of the study is the selection of a geographically distributed diverse, multi-ethnic population and long-term duration of five years for all the participants. The study design ensures the generalizability of the trial results and provides guidance in clinical decision making for the increasing number of people with newly diagnosed type 2 diabetes.
“In designing the study, we thought about what was actually needed to make a difference in the management of type 2 diabetes. Diabetes is a worldwide epidemic, so we decided to go to every continent and ethnic group, as well as countries with different kinds of healthcare systems, from the most advanced to the very basic,” explained Dr. Paldánius.
Professor Thomas and Dr. Paldánius were in Manila recently for the Philippine launch of the Verify study.
“There are an estimated 3.8 million Filipinos with type 2 diabetes. We hope that the promising results of the Verify study can help improve patient outcomes and type 2 diabetes treatment,” said Jugo Tsumura, country president and managing director of Novartis Healthcare Philippines.