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

Abstract

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<30 or <15ml/min/1,73m²) and protects against hypoglycemia. 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 <0.05). At W12 in G2 vs. G1, time in range (70-180 mg/dl) was greater (77.2 vs. 69.5%, p <0.05), time spent > 180 mg/dl was lower (21.27 vs. 39.03%, p <0.05), there was no difference in time spent <70 mg/dl (1.54 vs. 1.45%, NS). At W12, HbA1C and insulin requirements were respectively 6.9 ± 0.9% vs. 7.2 ± 1.1% (NS) and 49 ± 32 IU/d vs. 46 ± 23 IU/d (NS). There was no difference in adverse events between both groups. Overall, 8 symptomatic hypoglycemia occurred in G1 and 13 in G2. 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.