Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Japanese Subjects

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: biphasic insulin aspart 50

Study type: Interventional

Funder types: Industry

Identifiers

NCT01620437

BIASP-1581

Details and patient eligibility

About

This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.

Enrollment: 30 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI (body mass index) between 19-29 kg/m^2 (both inclusive)
• Fasting blood glucose between 3.8-6.0 mmol/L (both inclusive)
• Non-smokers

Exclusion criteria

• Subjects with a first-degree relative with diabetes mellitus
• Subjects smoke 5 cigarettes or more per day

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Formulation A

Experimental group

Treatment:

Drug: biphasic insulin aspart 50

Formulation B

Experimental group

Treatment:

Drug: biphasic insulin aspart 50