A Prospective, Multicenter, Randomized, Open-label Study of 12 Week Duration to Evaluate the Effect of VILDagliptin Added to Insulin on Glycaemic Control in haemoDIALyzed Patients With Type 2 Diabetes: Probe Analysis of CGM

Diabetes is a major concern for dialysis units, as it is now the most common cause of end-stage renal disease in France. In 2010 at initiation of dialysis treatment, more than one patient out of two had at least one cardiovascular disease and 40 % diabetes (94 % Type 2 diabetes) and especially in East part of France.

Diabetic patients on dialysis have a high burden of morbidity and mortality, particularly from cardiovascular disease. Tight glycaemic and blood pressure control in diabetic patients has an important impact in reducing risk of progression nephropathy. Data are scarce on how diabetes should best be treated in dialysis patients. The evidence for improving glycaemic control in patients on dialysis having an impact on mortality or morbidity is sparse. Indeed, many factors make improving glycaemic control in patients on dialysis very challenging, including therapeutic difficulties with hypoglycaemic agents, monitoring difficulties, dialysis strategies that exacerbate hyperglycaemia or hypoglycaemia.

Standard oral drugs therapy for hyperglycaemia (eg, metformin, sulfonylureas, ) are contraindicated in patients on dialysis. Thus insulin has been the mainstay of treatment. Newer therapies for hyperglycaemia, such as gliptins and glucagon-like peptide-1 analogues have become available, but until recently, renal failure has precluded their use. Newer gliptins, however, are now licensed for use in 'severe renal failure', although they have yet to be trialed in dialysis patients.

The investigators study, using continuous glucose monitoring as a new tool for monitoring of therapy should provide information on vildagliptin in add on therapy to insulin in this population.

Study Overview

• Status: Completed
• Conditions: Haemodialyzed, Type 2 Diabetes
• Intervention / Treatment: Drug: Insulin; Drug: Vildagliptin (Galvus)

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CH d'Amiens
  • Besançon, France, 25030
    • CH de Besançon
  • Colmar, France, 68000
    • AURAL Colmar
  • Colmar, France, 68024
    • Hospices Civils de Colmar
  • Dijon, France, 21079
    • CH de Dijon
  • Mulhouse, France, 68070
    • CH de Mulhouse
  • Mulhouse, France, 68070
    • AURAL Mulhouse
  • Nancy, France, 54000
    • CH de Nancy
  • Strasbourg, France, 67000
    • Clinique Sainte Anne
  • Strasbourg, France, 67200
    • AURAL Strasbourg
  • Strasbourg, France, 67091
    • Hopitaux universitaires de Strasbourg
  • Strasbourg, France, 67000
    • AURAL Clinique Sainte Anne
  • Valenciennes, France, 59300
    • Ch de Valenciennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients treated by haemodialysis for more than 3 months with 1g/L glucose in dialysate fluid
• Patients treated by stable doses of insulin (any regimen) for Type 2 diabetes without any oral antidiabetic agent
• Age > 18 years
• TGO, TPO and lipase < 3x ULN
• effective means of contraception

Non-inclusion Criteria:

• Blood transfusion in the 2 previous months
• Life expectancy less than 1 year
• Chronic inflammatory disease
• Steroid treatment > 5mg/day
• Cancer (evolutive or requiring chemotherapy or radiotherapy) with the exception of breast intraductal carcinoma operated
• Patient waiting for programmed surgery
• History of cardiovascular disease (stroke, coronary heart disease, hospitalization for heart failure) in the 4 previous months
• Patients suffering from stage 3 and 4 cardiac insufficiency
• Non-compliant patients
• History of pancreatitis
• History of angioedema
• Hypersensitivity to the active substance or to any of the excipients of Galvus®
• Pregnancy or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Insulin alone; Use the usual frequency and dose	Drug: Insulin; Insulin
Experimental: Insulin and Vildagliptin; vildagliptin 50 mg/day during 3 months	Drug: Insulin; Insulin; Drug: Vildagliptin (Galvus); Use Vildagliptin (50 mg/day) added to insulin during 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean glucose value of CGM [M] to be averaged from day 2 and day 3 of CGM	up to day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM parameters at baseline and month 3	glucose area under the curve (AUC) for glucose value higher than 7.7 mmol/l; number of glucose values under 3.3 mmol/l; hypoglycaemic events at baseline, month 3; number of minor hypoglycaemic events per month; number of major hypoglycaemic events at month 3; number of nocturnal hypoglycaemic events per month; variability glycemic index: MAGE, CV	Other CGM parameters at baseline and month 3
Number of hypoglycaemic events	hypoglycaemic events at baseline, month 3; number of minor hypoglycaemic events per month; number of major hypoglycaemic events at month 3; number of nocturnal hypoglycaemic events per month	Hypoglycaemic events at baseline, month 3
Mean HbA1C and Glycated albumin		HbA1C and Glycated albuminat baseline and month 3

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Collaborators: Novartis
• Investigators: Principal Investigator: François CHANTREL, MD, AURAL - Mulhouse; Principal Investigator: Alexandre KLEIN, MD, Hospices Civils de Colmar; Principal Investigator: Olivier IMHOFF, MD, AURAL Clinique Saint-Anne de Strasbourg; Principal Investigator: Alexandre KLEIN, MD, AURAL - Colmar; Principal Investigator: Dominique FLEURY, MD, Ch de Valenciennes; Principal Investigator: Bruno VERGES, MD-PhD, Centre Hospitalier Universitaire Dijon; Principal Investigator: Philippe ZAOUI, MD-PhD, University Hospital, Grenoble; Principal Investigator: Philippe ZAOUI, MD-PH, AGDUC - Grenoble; Principal Investigator: Gabriel CHOUKROUN, MD PhD, Centre Hospitalier Universitaire, Amiens; Principal Investigator: Sophie BOROT, MD, CHU de Besancon; Principal Investigator: François CHANTREL, MD, CH de Mulhouse; Principal Investigator: Olivier IMHOFF, MD, Clinique Sainte Anne de Strasbourg; Principal Investigator: Kristian KUNTZ, MD, AURAL de Strasbourg; Principal Investigator: Joëlle CRIDLIG, MD, Central Hospital, Nancy, France

Publications and helpful links

General Publications

• Munch M, Meyer L, Hannedouche T, Kunz K, Alenabi F, Winiszewski P, Baltzinger P, Smagala A, Klein A, Dorey F, Fleury D, Verier-Mine O, Guerci B, Cridlig J, Borot S, Ducloux D, Meyer N, Hadjadj S, Chantrel F, Kessler L. Effect of adding vildagliptin to insulin in haemodialysed patients with type 2 diabetes: The VILDDIAL study, a randomized, multicentre, prospective study. Diabetes Obes Metab. 2020 Jun;22(6):978-987. doi: 10.1111/dom.13988. Epub 2020 Feb 25.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: June 5, 2014
• First Submitted That Met QC Criteria: June 26, 2014
• First Posted (Estimated): June 27, 2014

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitriles; Pyrrolidines; Insulins; Pancreatic Hormones; Proinsulin; Vildagliptin; Insulin
• Other Study ID Numbers: 5706; 2013-004737-33 (EudraCT Number)