Randomized, Multicentric, Prospective Study Assessing the Effect of Adding VILDagliptin to Insulin in Hemodialysed Type 2 Diabetic Patients—The VILDDIAL Study

Introduction: Type 2 diabetic patients (T2D) undergoing chronic dialysis are at very high cardiovascular risk, requiring optimization of insulin treatment. Vildagliptin (Galvus), can be used in severe and terminal renal impairment (eGFR The aim of this study was to evaluate the efficacy and safety of vildagliptin (50 mg/d) on top of insulin in hemodialysed T2D. Methods: Sixty-five patients treated with multiple daily insulin injections were randomized (group 1-G1, n=33-usual insulin regimen, group 2-G2, n=32-addition of vildagliptin) in a multicentric, prospective, controlled, open-label, 12 weeks- study. Glucose control was evaluated using Continuous Glucose Monitoring (CGM, I-Pro Medtronic) for 48h, at Week 1 (W1) and Week 12 (W12), HbA1c and daily insulin needs. Statistical analysis was performed in intention to treat. Results: Both groups were comparable (G1 vs. G2) for age (71.3 ± 7.4 vs. 69.7 ± 9.6 years), BMI (32.1 ± 6 vs. 34.5 ± 6.4 kg/m²), daily doses of insulin (47.7 ± 29.2 vs. 51.3 ± 25.4 IU), HbA1c (7.3 ± 1.1 vs. 7.3 ± 1.1%), and mean glucose at W1 (using CGM, 167.6 ± 58.3 vs. 149.4 ± 76.1 mg/dl). At W12 compared to W1, mean glucose decreased significantly only in G2 (149.4 to 136.9 mg/dl, p 180 mg/dl was lower (21.27 vs. 39.03%, p Conclusion: Adding vildagliptin (50 mg/d) to insulin in hemodialysed T2D improves glycemic control by increasing time spent in normoglycemia and reducing time in hyperglycemia, without increasing time in hypoglycemia. Disclosure M. Munch: None. A. Smagala: None. L. Meyer: None. N. Meyer: None. O. Verier: None. D.I. Fleury: None. B. Guerci: None. T. Hannedouche: None. J. Cridlig: None. P. Baltzinger: None. D. Ducloux: None. S. Borot: Consultant; Self; Abbott, Animas Corporation, Johnson & Johnson Diabetes Institute, LLC., Medtronic, Roche Diabetes Care Health and Digital Solutions. K.W. Kunz: None. F. Alenabi: None. P. Winiszewski: Other Relationship; Self; Abbott, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk Inc., Eli Lilly and Company, Sanofi. F. Chantrel: None. L. Kessler: None.