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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Haemodialyzed, Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin alone

Use the usual frequency and dose

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

Insulin

Insulin and Vildagliptin

vildagliptin 50 mg/day during 3 months

Group Type EXPERIMENTAL

No interventions assigned to this group

Interventions

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Vildagliptin (Galvus)

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

Intervention Type DRUG

Insulin

Intervention Type DRUG

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Role: PRINCIPAL_INVESTIGATOR

AURAL de Strasbourg

Locations

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.

Reference Type RESULT

PMID: 32048396 (View on PubMed)

Other Identifiers

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5706

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Insulin alone

Insulin

Insulin and Vildagliptin

Interventions

Vildagliptin (Galvus)

Insulin

Eligibility Criteria

Inclusion Criteria

Sponsors

Novartis

University Hospital, Strasbourg, France

Responsible Party

Principal Investigators

François CHANTREL, MD

Alexandre KLEIN, MD

Olivier IMHOFF, MD

Alexandre KLEIN, MD

Dominique FLEURY, MD

Bruno VERGES, MD-PhD

Philippe ZAOUI, MD-PhD

Philippe ZAOUI, MD-PH

Gabriel CHOUKROUN, MD PhD

Joëlle CRIDLIG, MD

Sophie BOROT, MD

François CHANTREL, MD

Olivier IMHOFF, MD

Kristian KUNTZ, MD

Locations

CH d'Amiens

CH de Besançon

AURAL Colmar

Hospices civils de Colmar

CH de Dijon

AURAL Mulhouse

CH de Mulhouse

CH de Nancy

AURAL Clinique Sainte Anne

Clinique Sainte Anne

Hôpitaux Universitaires de Strasbourg

AURAL Strasbourg

CH de Valenciennes

Countries

References

Other Identifiers

5706