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

INTERVENTION: Trade Name: Galvus Product Name: Vildagliptine Pharmaceutical Form: Tablet INN or Proposed INN: VILDAGLIPTIN CAS Number: 274901‐16‐5 Other descriptive name: (S)‐1‐[3‐hydroxy‐adamant‐1‐ylamino)‐acetyl]‐pyrolidine‐2 (S) carbonitrile Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Trade Name: LANTUS 100 unités/ml solution injectable Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULIN GLARGINE Other descriptive name: INSULIN GLARGINE (GENETICAL RECOMBINATION) Concentration unit: U/ml unit(s)/millilitre Concentration type: equal Concentration number: 100‐ Trade Name: LANTUS 100 unités/ml solution injectable en cartouche Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULIN GLARGINE Other descriptive name: INSULIN GLARGINE (GENETICAL RECOMBINATION) Concentration unit: U/ml unit(s)/millilitre Concentration type: equal Concentration number: 100‐ Trade Name: LANTUS 100 unités/ml solution injectable en cartouche pour OptiClik Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULIN GLARGINE Other descriptive name: INSULIN GLARGINE (GENETICAL RECOMBINATION) Concentration unit: U/ml unit(s)/millilitre Concentration type: equal Concentration number: 100‐ Trade Name: Lantus OptiSet 100 unités/ml solution injectable en stylo prérempli Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULIN GLARGINE Other descriptive name: INSULIN G CONDITION: 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 Therapeutic area: Diseases [C] ‐ Nutritional and Metabolic Diseases [C18] 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 < 83 years ‐ HbA1c > 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 PRIMARY OUTCOME: ; 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 OUTCOME: ; 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