An open label, multiple-period glucose clamp study in type-1 diabetic patients and healthy subjects. This study was investigating the pharmacodynamic and pharmacokinetic variability and reproducibility of glucose clamping in patients and healthy subjects.
All study subjects received a single subcutaneous dose of basal insulin, which was followed by repeated blood sampling for up to 30 hours. Once blood glucose dropped to a specified value as the insulin started to take effect, a glucose infusion in each subject was started, and then a stable glucose reading was maintained.
Glucose clamping is a scientific procedure used to assess the efficacy of different insulin preparations. From the blood glucose measurements taken throughout the duration of the clamp, and the rate of glucose infusion, a time-action profile can be generated, which can be used to describe the efficacy and onset of insulin action over time.