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Effect of adding vildagliptin to insulin in haemodialysed patients with type 2 diabetes: The VILDDIAL study, a randomized, multicentre, prospective study
Author(s) -
Munch Marion,
Meyer Laurent,
Hannedouche Thierry,
Kunz Kristian,
Alenabi Farideh,
Winiszewski Patrice,
Baltzinger Philippe,
Smagala Agnès,
Klein Alexandre,
Dorey François,
Fleury Dominique,
VerierMine Odile,
Guerci Bruno,
Cridlig Joëlle,
Borot Sophie,
Ducloux Didier,
Meyer Nicolas,
Hadjadj Samy,
Chantrel François,
Kessler Laurence
Publication year - 2020
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.13988
Subject(s) - vildagliptin , insulin , medicine , type 2 diabetes , diabetes mellitus , endocrinology , hypoglycemia , nph insulin , insulin glargine
Aim To evaluate the effect of adding the dipeptidyl‐peptidase‐4 inhibitor vildagliptin to insulin on the glycaemic control of patients with type 2 diabetes undergoing haemodialysis. Methods Overall, 65 insulin‐treated patients with type 2 diabetes undergoing haemodialysis (HbA1c: 7.3% ± 1.1%; age: 70.5 ± 8.5 years) were randomized (1:1) either to receive vildagliptin 50 mg/day in addition to insulin (vildagliptin‐insulin group) or to pursue their usual insulin regimen (insulin‐only group). Continuous glucose monitoring (CGM) was performed for 48 ± 6 hours at baseline and at week 12. The primary study endpoint was change from baseline in mean interstitial glucose using CGM. The secondary endpoints included other CGM variables and glucose control markers. Results After 12 weeks, a greater reduction in mean CGM glucose from baseline was observed in the vildagliptin‐insulin group compared with the insulin‐only group, although the between‐treatment difference was not statistically significant (mean difference [CI 95%]: −0.96 mmol/L [−2.09; 0.18] vs. ‐0.29 mmol/L [−1.29; 0.76], P = 0.32). However, a significant decrease from baseline in HbA1c, glycated albumin and insulin daily doses was observed in the vildagliptin‐insulin group versus the insulin‐only group (−0.6% [−1.19; −0.1], P < 0.01), in the vildagliptin‐insulin group versus no change in the insulin‐only group (−130.6 μmol/L [−271; 10.7] vs. +36.2 μmol/L [−164.4; 236.9], P = 0.04 and − 5.9 IU/day [−1.8; 7.1] vs. +1.1 IU/day [−14.5; 16.6], P = 0.01, respectively). There was no significant difference in the percentage of time spent in hypoglycaemia using CGM, occurrence of severe hypoglycaemia or number of adverse events. Conclusion In this study, vildagliptin added to insulin improved glycaemic control with an associated insulin‐sparing effect in patients with type 2 diabetes undergoing haemodialysis and was well tolerated.