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
- Conditions
- haemodialyzed patients with type 2 diabetesMedDRA version: 18.0 Level: LLT Classification code 10049746 Term: Insulin-requiring type II diabetes mellitus System Organ Class: 100000004861MedDRA version: 18.0 Level: LLT Classification code 10018874 Term: Haemodialysed System Organ Class: 100000004865Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2013-004737-33-FR
- Lead Sponsor
- Hôpitaux Universitaires de Strasbourg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method