Bioequivalence of Two Insulatard® Formulations in Healthy Subjects

Phase 1

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Formulation B	isophane human insulin	-
Formulation A	isophane human insulin	-

Primary Outcome Measures

Name	Time	Method
Area under the serum insulin concentration-time curve (AUC 0-24 hours)
Maximum serum insulin concentration (Cmax)

Secondary Outcome Measures

Name	Time	Method
Adverse events
Time to maximum serum insulin concentration (tmax)
Terminal serum insulin half life (t½)
Area under the serum insulin concentration-time curve (AUC 0-inifinity hours)

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