Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2020 Jun;22(6):978-987.
doi: 10.1111/dom.13988. Epub 2020 Feb 25.

Effect of adding vildagliptin to insulin in haemodialysed patients with type 2 diabetes: The VILDDIAL study, a randomized, multicentre, prospective study

Marion Munch  1 , Laurent Meyer  1 , Thierry Hannedouche  2 , Kristian Kunz  3 , Farideh Alenabi  3 , Patrice Winiszewski  4 , Philippe Baltzinger  1 , Agnès Smagala  5 , Alexandre Klein  6 , François Dorey  7 , Dominique Fleury  8 , Odile Verier-Mine  7 , Bruno Guerci  9 , Joëlle Cridlig  10 , Sophie Borot  11 , Didier Ducloux  12 , Nicolas Meyer  13 , Samy Hadjadj  14 , François Chantrel  15 , Laurence Kessler  1   16
Affiliations
Randomized Controlled Trial

Effect of adding vildagliptin to insulin in haemodialysed patients with type 2 diabetes: The VILDDIAL study, a randomized, multicentre, prospective study

Marion Munch et al. Diabetes Obes Metab. 2020 Jun.

Abstract

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.

Keywords: continuous glucose monitoring; haemodialysis; insulin treatment; type 2 diabetes; vildagliptin.

PubMed Disclaimer

References

REFERENCES

    1. WHO. Global report on diabetes. WHO Library. 2016.
    1. Longenecker JC, Coresh J, Klag MJ, et al. Validation of comorbid conditions on the end-stage renal disease medical evidence report: the CHOICE study. Choices for Healthy Outcomes in Caring for ESRD. J Am Soc Nephrol. 2000;11:520-529.
    1. Lim WH, Johnson DW, Hawley C, et al. Type 2 diabetes in patients with end-stage kidney disease: influence on cardiovascular disease-related mortality risk. Med J Aust. 2018;209:440-446.
    1. Papatheodorou K, Papanas N, Banach M, Papazoglou D, Edmonds M. Complications of Diabetes 2016. J Diabetes Res. 2016;2016:6989453.
    1. Ricks J, Molnar MZ, Kovesdy CP, et al. Glycemic control and cardiovascular mortality in hemodialysis patients with diabetes: a 6-year cohort study. Diabetes. 2012;61:708-715.

Publication types

Grants and funding