Diabetes
Conditions
Keywords
Levemir, Lantus, Insulatard, Pharmacodynamics, Healthy humans
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).
Interventions
DRUGInsulin detemir
0.4 U/kg bw insulin detemir injected s.c. in the thigh.
DRUGInsulin glargine
0.4 U/kg bw insulin glargine injected s.c. in the thigh
DRUGInsulatard
0.4 U/kg bw NPH insulin injected s.c. in the thigh
Sponsors
The Danish Diabetes Association
The Institute of Experimental Clinical Research, University of Aarhus
Novo Nordisk A/S
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Male * BMI 20 - 50 kg/m2 * Blood pressure \< 140/90 mmHg * signed informed consent * Caucasien
Exclusion criteria
* Diabetes or other disease * Alcohol or drug abuse * Smoking * Use of prescription drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate. | 24 hours |
Countries
Denmark
Outcome results
None listed