Early Combination of Vildagliptin, Metformin Reduces Treatment Failure in Patients Newly Diagnosed With Type 2 Diabetes
May 25, 2021

By Shazia Qureshi

VIRTUAL -- May 25, 2021 -- In patients with newly diagnosed type 2 diabetes, using a combination treatment of vildagliptin plus metformin reduced the risk of initial treatment failure by 41% versus initiating treatment with metformin alone, according to a study presented at the Virtual 23rd European Congress of Endocrinology (ECE).

“This is consistent with the global population of the VERIFY study where the risk of initial treatment failure was reduced by 49% with the combination approach,” said remarked Francesc Xavier Cos, MD, Institut Català de la Salut, and Universitat Autònoma de Barcelona, Barcelona, Spain.

The findings come from a subanalysis of the VERIFY study. The researchers only looked at the 1,048 European patients from the trial. Patients had been randomised 1:1 to either early combination treatment using vildagliptin plus metformin or initial metformin monotherapy. In the metformin monotherapy group, vildagliptin could be administered to patients if their initial treatment was not able to maintain haemoglobin A1C (Hb A1C)

All patients had been diagnosed with type 2 diabetes within the previous 2 years, had a body mass index between 22 and 40 kg/m2, and had mild hyperglycaemia, defined as an Hb A1C of 6.5% to 7.5%).

Time to initial treatment failure -- the primary endpoint -- was a median of 61.9 months among patients in the combination treatment group, compared with 36.6 months in the metformin monotherapy group (hazard ratio [HR] = 0.59; 95% confidence interval [CI], 0.50-0.70; P

Over 5 years, an initial treatment failure was observed in 45.3% of patients in the combination treatment group versus 61.2% of the metformin monotherapy group.

In addition, the risk of a second treatment failure -- defined for both groups as receiving and failing combination therapy -- was found to be lower in the combination group versus the monotherapy group, but this did not reach statistical significance (HR = 0.84; 95% CI, 0.68-1.03; P = .0898).

Hypoglycaemia was reported by 0.3% of patients in the combination group and in 0.2% of patients in the monotherapy group. All cases were grade 1 and none led to study discontinuation. Serious adverse events occurred in 18.4% and 21.8% of patients, respectively, and adverse events leading to study discontinuation occurred in 2.9% and 5.0% of patients, respectively.

Funding for this study was provided by Novartis.

The ECE is sponsored by the European Society of Endocrinology.

[Presentation title: Long-Term Clinical Benefits With Early Combination Therapy in Patients With Newly Diagnosed Type 2 Diabetes From Europe: Insights From the VERIFY Study. Abstract PEP2.4]