Overview
Metabolic Effect of Insulin Aspart and Human Insulin in Different Doses
Status:
Completed
Completed
Trial end date:
2002-06-01
2002-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The metabolic effect of three different doses of insulin aspart and human insulin are investigated with the euglycaemic glucose clamp technique.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Profil Institut für Stoffwechselforschung GmbHCollaborator:
Novo Nordisk A/STreatments:
Insulin
Insulin Aspart
Insulin degludec, insulin aspart drug combination
Insulin, Globin Zinc
Insulin, Long-Acting
Criteria
Inclusion criteria:- Signed informed consent obtained before any trial-related activities
- Healthy subjects between 18 and 45 years inclusive
- Considered generally healthy upon completion of medical history and physical
examination
- Body mass index (BMI) < 27 kg/m2
- HbA1c < 6,1 %
- Non-smoker for at least three months
- Females of childbearing potential using acceptable methods of contraception, including
tubal ligation, an intrauterine device (IUD), the oral contraceptive pill or barrier
methods.
Exclusion Criteria:
- 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