Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in the United states of America (USA). The aim of this trial is to compare two formulations of biphasic insulin aspart 30 in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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:

• BMI (body mass index) between 18 and 28 kg/m^2, both inclusive

• Subject is a nonsmoker for at least 3 months

• Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data

• Fasting plasma glucose between 80 and 110 mg/dl

Exclusion Criteria:

• •Any clinically significant disease history of systemic or organ disease

• •Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)

• •In females of child bearing potential: Pregnancy, lactating, breastfeeding, intent to become pregnant within the next 6-months or judged to be using inadequate contraceptive measures (adequate contraceptive measures include: condom, intrauterine devices). ß-hCG pregnancy test must be negative