Overview

Bioequivalence of Two Insulatard® Formulations in Healthy Subjects

Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
0
Participant gender:
All
Summary
This trial is conducted in Europe. The aim of this trial is to test for bioequivalence between two formulations of Insulatard® in healthy subjects.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Insulin
Insulin, Globin Zinc
Insulin, Isophane
Isophane insulin, beef
Isophane Insulin, Human
Criteria
Inclusion Criteria:

- Considered generally healthy upon completion of medical history and physical
examination as judged by the Investigator

- Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2, inclusive

- Non-smoker, defined as no nicotine consumption for at least one year

- Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)

Exclusion Criteria:

- Previous participation in this trial or other clinical trials within the last 3 months

- Body weight above 87.5 kg

- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate
contraceptive measures (intrauterine device (IUD) that has been in place for at least
3 months, or sterilisation, or the oral contraceptive pill, which should have been
taken without difficulty for at least 3 months, an approved hormonal implant)

- History of alcohol or drug abuse