Haemodialyzed, Type 2 Diabetes
Conditions
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.
Interventions
Use Vildagliptin (50 mg/day) added to insulin during 3 months
DRUGInsulin
Insulin
Sponsors
University Hospital, Strasbourg, France
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| CGM parameters at baseline and month 3 | Other 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 |
| Number of hypoglycaemic events | Hypoglycaemic events at baseline, month 3 | 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 |
| Mean HbA1C and Glycated albumin | HbA1C and Glycated albuminat baseline and month 3 | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORFrançois CHANTREL, MD
AURAL - Mulhouse
PRINCIPAL_INVESTIGATORAlexandre KLEIN, MD
Hospices Civils de Colmar
PRINCIPAL_INVESTIGATOROlivier IMHOFF, MD
AURAL Clinique Saint-Anne de Strasbourg
PRINCIPAL_INVESTIGATORDominique FLEURY, MD
CH de Valenciennes
PRINCIPAL_INVESTIGATORBruno VERGES, MD-PhD
Centre Hospitalier Universitaire Dijon
PRINCIPAL_INVESTIGATORPhilippe ZAOUI, MD-PhD
University Hospital, Grenoble
PRINCIPAL_INVESTIGATORPhilippe ZAOUI, MD-PH
AGDUC - Grenoble
PRINCIPAL_INVESTIGATORGabriel CHOUKROUN, MD PhD
Centre Hospitalier Universitaire, Amiens
PRINCIPAL_INVESTIGATORJoëlle CRIDLIG, MD
Central Hospital, Nancy, France
PRINCIPAL_INVESTIGATORSophie BOROT, MD
CHU de Besançon
PRINCIPAL_INVESTIGATORKristian KUNTZ, MD
AURAL de Strasbourg
Outcome results
None listed