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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: biphasic insulin aspart 50

• Registration Number: NCT01527630
• 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: 2002-11-16
• Primary Completion: 2003-01-08
• Study Completion: 2003-01-08
• Study First Submitted: 2012-02-02
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-07
• 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

• Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator.
• Body Mass Index (BMI) between 19-29 kg/m^2 (inclusive)
• Fasting plasma glucose between 3.8-6.0 mmol/L (both inclusive)

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Exclusion Criteria

• Clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator or Sub-Investigator
• Any serious systemic infectious disease that had occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator
• Any inter-current illness that might affect blood glucose, as judged by the Investigator or Sub-Investigator
• Hepatitis B or C, or HIV (human immunodeficiency virus) positive
• Subjects with a first degree relative with diabetes mellitus
• History of or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder
• Subjects who consumed more than 28 units of alcohol per week or who had a significant history of alcoholism or drug/chemical abuse
• Subjects who smoked more than 5 cigarettes per day
• Subjects who had taken part in strenuous exercise within 7 days prior to the screening

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Area under the insulin aspart concentration-time curve
MRT, mean residence time
Tmax, time to maximum insulin aspart concentration
t½, terminal half-life

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan