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

Phase 1

Completed

• Conditions: Healthy; Diabetes
• Interventions: Drug: biphasic insulin aspart 50

• Registration Number: NCT01620437
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11-29
• Primary Completion: 2003-12-30
• Study Completion: 2003-12-30
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-15
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Formulation B	biphasic insulin aspart 50	-
Formulation A	biphasic insulin aspart 50	-

Primary Outcome Measures

Name	Time	Method
Area under the insulin aspart curve in the interval from 0-16 hours
Cmax, maximum insulin aspart concentration

Secondary Outcome Measures

Name	Time	Method
tmax, time to maximum insulin aspart concentration
Area under the insulin aspart curve
Mean residence time (MRT)
t½, terminal half-life
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan