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

University Hospital, Strasbourg, France

Status and phase

Completed

Phase 4

Conditions

Haemodialyzed, Type 2 Diabetes

Treatments

Drug: Vildagliptin (Galvus)

Drug: Insulin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02176681

5706

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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