Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy Subjects

• Status: Completed
• Trial end date: 2000-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Biphasic Insulins; Insulin; Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• Body mass index between 18 and 28 kg/m^2 inclusive

• HbA1c within the normal laboratory range

• 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:

• Subjects who have received any investigational drug in the 3 months prior to the start of dosing

• Any disease requiring regular use of non topical prescription medicines

• Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug

• Any intercurrent illness or endocrine disorders that may affect blood glucose

• Subject with a history of drug or alcohol dependence

• Subject with a first degree relative with diabetes mellitus

• Subject with a history of clinically relevant allergic reactions to medical products

• Subjects who have donated any blood or plasma in the past 3 month preceding screening