Effect of adding vildagliptin to start of insulin treatment in combination with metformin in patients with type 2 diabetes - Effect of adding vildagliptin to insulin treatment
- Conditions
- patients with type 2 diabetes, failing on maximal oral glucose-lowering drugs, starting on insulin therapy in combination with standard metfromin (2 x 850)MedDRA version: 9.1Level: LLTClassification code 10012594Term: Diabetes
- Registration Number
- EUCTR2009-010967-18-NL
- Lead Sponsor
- niversity Medical Centre Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
- Type 2 diabetes mellitus
- Failing on oral-glucose-lowering medication: maximum tolerated doses of metformin, and/ or sulphonylurea and/ or TZD
- Male and female
- BMI 25-35
- HbA1c 7.0-9.0 %
- Age 25-75 y
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Pregnant women or women in the fertile period of life without adequate birth-control
- Type I DM, or secondary form of DM (eg pancreatic injury, prednisone induced)
- Acute metabolic complications (severe hypoglycaemia, hospital-admission for uncontrolled
- Keto-acidosis) during the last 6 months
- Severe cardiac (LVEF < 30%) or hepatic, or renal impairment (creatinine clearance <50 ml/min)
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