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

NCT02176681 | Completed Phase 4 DMC

• 2 other identifiers: 57062013-004737-33
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Haemodialyzed, Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Mean glucose value of CGM [M] to be averaged from day 2 and day 3 of CGM

  up to day 3

Secondary Outcomes (3)

• CGM parameters at baseline and month 3

  Other CGM parameters at baseline and month 3

• Number of hypoglycaemic events

  Hypoglycaemic events at baseline, month 3

• Mean HbA1C and Glycated albumin

  HbA1C and Glycated albuminat baseline and month 3

Study Arms (2)

Insulin alone

ACTIVE COMPARATOR

Use the usual frequency and dose

Drug: Insulin

Insulin and Vildagliptin

EXPERIMENTAL

vildagliptin 50 mg/day during 3 months

Interventions

Vildagliptin (Galvus) DRUG

Use Vildagliptin (50 mg/day) added to insulin during 3 months

Insulin DRUG

Insulin

Insulin alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Novartis: collaborator
• University Hospital, Strasbourg, France: lead

Study Sites (13)

CH d'Amiens

Amiens, 80054, France

Location

CH de Besançon

Besançon, 25030, France

Location

AURAL Colmar

Colmar, 68000, France

Location

Hospices civils de Colmar

Colmar, 68024, France

Location

CH de Dijon

Dijon, 21079, France

Location

AURAL Mulhouse

Mulhouse, 68070, France

Location

CH de Mulhouse

Mulhouse, 68070, France

Location

CH de Nancy

Nancy, 54000, France

Location

AURAL Clinique Sainte Anne

Strasbourg, 67000, France

Location

Clinique Sainte Anne

Strasbourg, 67000, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

AURAL Strasbourg

Strasbourg, 67200, France

Location

CH de Valenciennes

Valenciennes, 59300, France

Location

Related Publications (1)

• 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.

  PMID: 32048396 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• 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

• Joëlle CRIDLIG, MD

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

• Sophie BOROT, MD

  CHU de Besançon

  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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 16, 2026

Record last verified: 2025-12

Locations

FR (13)