Effect of adding vildagliptin to start of insulin treatment in patients with type 2 diabetes
Phase 3
Completed
- Conditions
- Diabetes10018424
- Registration Number
- NL-OMON37974
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Type 2 diabetes
Failure on oral medication and start of insulin treatment with once daily long-acting insulin (glargine)
HbA1c 7-9%
BMI 25-35
Age 25-75
Exclusion Criteria
-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 hyperglycemia) during the last 6 months
- Severe cardiac (LVEF < 30%) or a history of or current hepatic, or renal impairment (creatinine clearance <50 ml/min)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>required insulin dose after 16 weeks of treatment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- weight<br /><br>- hypoglycemias<br /><br>- glucose variability (measured by continuous glucose monitoring system)<br /><br>- insulin and glucagon levels after mixed meal test<br /><br>- HbA1c, fructosamine<br /><br>- 24 hours measured blood pressure<br /><br>- lipid profile<br /><br>- markers of vascular function, inflammation and coagulation<br /><br>- advanced glycation end products measured by skin autofluorescence </p><br>