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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.


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.



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