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

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

Interventions

DRUG

Vildagliptin (Galvus)

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

DRUG

Insulin

Insulin

Sponsors & Collaborators

• Novartis

  collaborator INDUSTRY

• University Hospital, Strasbourg, France

  lead OTHER

Principal Investigators

• François CHANTREL, MD · AURAL - Mulhouse

• Alexandre KLEIN, MD · Hospices Civils de Colmar

• Olivier IMHOFF, MD · AURAL Clinique Saint-Anne de Strasbourg

• Alexandre KLEIN, MD · AURAL - Colmar

• Dominique FLEURY, MD · CH de Valenciennes

• Bruno VERGES, MD-PhD · Centre Hospitalier Universitaire Dijon

• Philippe ZAOUI, MD-PhD · University Hospital, Grenoble

• Philippe ZAOUI, MD-PH · AGDUC - Grenoble

• Gabriel CHOUKROUN, MD PhD · Centre Hospitalier Universitaire, Amiens

• Joëlle CRIDLIG, MD · Central Hospital, Nancy, France

• Sophie BOROT, MD · CHU de Besançon

• François CHANTREL, MD · CH de Mulhouse

• Olivier IMHOFF, MD · Clinique Sainte Anne de Strasbourg

• Kristian KUNTZ, MD · AURAL de Strasbourg

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-06-30

Primary Completion

2017-10-31

Completion

2017-10-31

Countries

• France

Study Locations