Metabolic Effect of Insulin Aspart and Human Insulin in Different Doses
- Conditions
- Diabetes Mellitus
- Interventions
- Drug: human regular insulin
- Registration Number
- NCT00513643
- Lead Sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Brief Summary
The metabolic effect of three different doses of insulin aspart and human insulin are investigated with the euglycaemic glucose clamp technique.
- Detailed Description
Double-blind, randomized, 6-period cross-over study in 16 healthy subjects. Each patient participates in 6 euglycemic glucose clamp experiments each.
The time interval between the study days is 2 to 28 days. At the clamp visits, subjects are connected to a Biostator (MTB Medizintechnik, Ulm, Germany) and receive an intravenous human insulin infusion (rate of 0.15 mU/kg/min) over the duration of each experiment to prevent a rise in endogenous insulin secretion. After a baseline period of 2 h the trial drug (6, 12, or 24 U of either Insulin Aspart or regular human insulin in random order) are administered s.c. with a syringe into the abdominal wall. Glucose infusion rates (GIR) necessary to keep blood glucose concentrations close to the clamp level of 90 mg/dl (5 mmol/l) are administered and recorded by the Biostator every minute for a period of 12 h post-dosing. Blood samples are drawn at regular intervals for the analysis of C-peptide and (depending on the trial drug administered) serum insulin or serum Insulin Aspart concentrations (measured with specific ELISAs).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Not provided
- Participation in any other clinical trial and receipt of any investigational drug within four weeks prior to this trial
- Previous participation in this trial
- Clinically significant abnormal haematology or biochemistry screening test
- Any disease requiring use of non topical prescription medicines
- Any serious systemic infectious disease that occurred in the four weeks prior to the first dose of test drug
- Any intercurrent illness that may affect blood glucose
- Current addiction to alcohol or substances of abuse as determined by the investigator
- Known or suspected allergy against insulin or any component of the composition of the trial drug
- Blood donation > 500 ml within the last nine weeks
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
- If female, subject is pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2 insulin aspart 12 U insulin aspart 6 human regular insulin 24 IU human regular insulin 1 insulin aspart 6 U insulin aspart 4 human regular insulin 6 IU human regular insulin 3 insulin aspart 24 U insulin aspart 5 human regular insulin 12 IU human regular insulin
- Primary Outcome Measures
Name Time Method AUC GIR 360-720 min at each dosing (6 times during the trial)
- Secondary Outcome Measures
Name Time Method PD endpoints like GIR max, t max/GIR, AUC GIR 0-120 min, AUC GIR 0-720 min, t >2/GIR, early and late t 50%/GIR at each dosing visit (6 times during the study) PK endpoints such as C max/ins, t max/ins, AUC ins 0-120 min, AUC ins 360-720 min, AUC ins 0-720 min at each dosing visit (6 times during the study)
Trial Locations
- Locations (1)
Profil Institut für Stoffwechselforschung GmbH
🇩🇪Neuss, Germany