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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: biphasic insulin aspart 70; Drug: biphasic insulin aspart 50; Drug: insulin aspart; Drug: biphasic insulin aspart 30

Study type: Interventional

Funder types: Industry

Identifiers

NCT01520831

BIASP-1086

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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35 participants in 4 patient groups

BIAsp 30

Experimental group

Treatment:

Drug: biphasic insulin aspart 30

BIAsp 50

Experimental group

Treatment:

Drug: biphasic insulin aspart 50

BIAsp 70

Experimental group

Treatment:

Drug: biphasic insulin aspart 70

Insulin aspart

Active Comparator group

Treatment:

Drug: insulin aspart