Clinical trial NCT02176681: 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Haemodialyzed, Type 2 Diabetes
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2014-06-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean glucose value of CGM [M] to be averaged from day 2 and day 3 of CGM
timeFrame: up to day 3
Secondary outcomes:
measure: CGM parameters at baseline and month 3
timeFrame: Other CGM parameters at baseline and month 3
measure: Number of hypoglycaemic events
timeFrame: Hypoglycaemic events at baseline, month 3
measure: Mean HbA1C and Glycated albumin
timeFrame: HbA1C and Glycated albuminat baseline and month 3
Other outcomes:
Locations:
city: Amiens
country: France
facility: CH d'Amiens
city: Besancon
country: France
facility: CH de Besançon
city: Colmar
country: France
facility: AURAL Colmar
city: Colmar
country: France
facility: Hospices civils de Colmar
city: Dijon
country: France
facility: CH de Dijon
city: Mulhouse
country: France
facility: AURAL Mulhouse
city: Mulhouse
country: France
facility: CH de Mulhouse
city: Nancy
country: France
facility: CH de Nancy
city: Strasbourg
country: France
facility: AURAL Clinique Sainte Anne
city: Strasbourg
country: France
facility: Clinique Sainte Anne
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Strasbourg
country: France
facility: AURAL Strasbourg
city: Valenciennes
country: France
facility: CH de Valenciennes
Study officials:
affiliation: AURAL - Mulhouse
name: François CHANTREL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospices Civils de Colmar
name: Alexandre KLEIN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AURAL Clinique Saint-Anne de Strasbourg
name: Olivier IMHOFF, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AURAL - Colmar
name: Alexandre KLEIN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH de Valenciennes
name: Dominique FLEURY, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire Dijon
name: Bruno VERGES, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Grenoble
name: Philippe ZAOUI, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AGDUC - Grenoble
name: Philippe ZAOUI, MD-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire, Amiens
name: Gabriel CHOUKROUN, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Hospital, Nancy, France
name: Joëlle CRIDLIG, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Besançon
name: Sophie BOROT, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH de Mulhouse
name: François CHANTREL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Sainte Anne de Strasbourg
name: Olivier IMHOFF, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AURAL de Strasbourg
name: Kristian KUNTZ, MD
role: PRINCIPAL_INVESTIGATOR
References: