haemodialyzed patients with type 2 diabetes MedDRA version: 18.0 Level: LLT Classification code 10049746 Term: Insulin-requiring type II diabetes mellitus System Organ Class: 100000004861 MedDRA version: 18.0 Level: LLT Classification code 10018874 Term: Haemodialysed System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Galvus
Product Name: Vildagliptine
Pharmaceutical Form: Tablet
INN or Proposed INN: VILDAGLIPTIN
CAS Number: 274901-16-5
Sponsors
Hôpitaux Universitaires de Strasbourg
Eligibility
Sex/Gender
All
Inclusion 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 and 7% Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Variability in EPO doses > 20% of doses (U/Kg/Month) or blood transfusion in the 2 previous months - Life expectancy less than 1 year - Chronic inflammatory disease - Steroid treatment - Cancer (evolutive or requiring chemotherapy or radiotherapy) - Patient waiting for programmed surgery - History of cardiovascular disease (stroke, coronary heart disease, hospitalization for heart failure) in the 4 previous months - Non-compliant patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To assess effect of vildagliptin added to insulin (versus insulin alone) on different parameters analyzed from CGM (at 3 months, change from baseline) 2. To assess effect of vildagliptin added to insulin versus insulin alone, on mean glycemia(venous sample before three dialysis sessions), fasting self blood monitoring glucose on the day of CGM start, HbA1C and Glycated albumin at month 3 versus baseline. 3. To evaluate insulin needs in both groups: total insulin daily doses and mean number of injections at month 3 versus baseline 4. To evaluate weight, BMI changes and % of patients with BMI = 30 kg/m² at month 3 versus baseline 5. To evaluate safety profile of vildagliptine added to insulin in hemodialyzed patients with type 2 diabetes 6. To evaluate the number of macrovascular events and patients mortality at month 3 ;Main Objective: to evaluate effect of vildagliptin added to insulin versus insulin alone on mean glucose value of CGM [M] (M to be averaged on 48+/6 hours of CGM) after a three-month treatment (change from baseline), in haemodialyzed patients with type 2 diabetes;Primary end point(s): Mean glucose value of CGM [M] to be averaged from day 2 and day 3 of CGM – change from baseline at month 3 ;Timepoint(s) of evaluation of this end point: After 3 months treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Other CGM parameters at baseline and month 3: - mean glucose value 2 h after meal - 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 Mean glycaemia (venous sample before three dialysis sessions) at baseline and month 3 Fasting self blood monitoring glucose before CGM at baseline and month 3 HbA1C and Glycated albumin albumin at baseline and month 3 Weight, insulin needs at baseline and month 3 Macrovascular events at baseline and month 3 Patient mortality at month 3 ;Timepoint(s) of evaluation of this end point: Après 3 mois de traitement | — |
Countries
France
Contacts
Public ContactDRCI
Hôpitaux Universitaires de Strasbourg
Outcome results
None listed