Visual Abstract

Background: In the VERIFY study, early combination therapy with vildagliptin+metformin (V+M) reduced initial and secondary treatment failure (TF) as compared to metformin therapy (MET). V+M was associated with improved fasting HOMA-B as compared to MET. Here we report prandial β-cell function in patients undergoing a standard meal test (SMT) from VERIFY.

Materials and Methods: Of the 2001 treatment-naïve newly-diagnosed patients with T2DM (HbA1c 6.5-7.5%), 455 consented to annual 2-hour SMT. The mean age, BMI and diabetes duration for MET group (n=227) was 54.4 years, 31.3 kg/m2 and 7.1 months, while for V+M (n=228) it was 55.1 years, 31.7 kg/m2 and 7.5 months, respectively. Insulin secretion rate (ISR) was measured by deconvolution method and β-cell function was assessed as change in AUCs of ISR/glucose (G) ratio from baseline (BL) to initial TF by ANCOVA adjusted by treatment approach.

Results: The median (IQR) time to initial TF for MET was 33.25 (15.05-not evaluable [NE]) months while for V+M it was NE (29.93-NE) for complete study population. Mean (SE) AUCISR/AUCG at BL was 27.12 (0.83) and 29.03 (0.87) for MET and V+M, respectively. At TF, adjusted mean change was lower in V+M (−0.98 [1.1]) vs. MET (−3.67 [1.08]), showing a significant difference between treatment groups (Δ: 2.69 [95% CI: 1.08, 4.30; p=0.001]; Figure).

Conclusion: The β-cell function after a meal declined more with MET compared to V+M at the time of initial TF in newly diagnosed patients with T2DM.

Disclosure

P. M. Paldanius: Consultant; Self; UPM Biomedicals, Speaker’s Bureau; Self; Novartis AG. D. R. Matthews: Advisory Panel; Self; Novartis Pharmaceuticals Canada Inc., Novo Nordisk. S. Del prato: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk, Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation, Sanofi.

Funding

Novartis

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.