Basal Insulins - Pharmacodynamics
- Conditions
- Diabetes
- Interventions
- Registration Number
- NCT00566124
- Lead Sponsor
- University of Aarhus
- Brief Summary
To purpose of this study is to compare the pharmacodynamic properties of insulin detemir, insulin glargine and NPH insulin after a single subcutaneous injection.
- Detailed Description
In this randomized, double-blind, euglycemic glucose clamp study, 10 healthy male volunteers received a subcutaneous injection of 0.4 U/kg insulin detemir, insulin glargine or NPH insulin on three separate study days in a cross-over design. After insulin administration, plasma glucose was maintained at 0.3 mmol/l below fasting level for 24 hours by manually adjusted glucose infusion. C-peptide, insulin, NEFA and counter regulatory hormones were measured throughout the clamp period. Endogenous glucose release (EGR) was assessed by the isotope dilution technique (3-3H-glucose).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 10
- Male
- BMI 20 - 50 kg/m2
- Blood pressure < 140/90 mmHg
- signed informed consent
- Caucasien
- Diabetes or other disease
- Alcohol or drug abuse
- Smoking
- Use of prescription drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Insulin detemir Insulin detemir 2 Insulin glargine Insulin glargine 3 Insulatard NPH insulin
- Primary Outcome Measures
Name Time Method Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate. 24 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medical department M (Endocrinology and Diabetes), Aarhus University Hospital
🇩🇰Aarhus, DK, Denmark