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

NCT01527630 | Completed Phase 1

• 1 other identifier: BIASP-1504
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Area under the insulin aspart concentration-time curve in the interval from 0 to 16 hours

• Cmax, maximum insulin aspart concentration

Secondary Outcomes (4)

• Area under the insulin aspart concentration-time curve

• Tmax, time to maximum insulin aspart concentration

• MRT, mean residence time

• t½, terminal half-life

Study Arms (2)

Formulation A

EXPERIMENTAL

Drug: biphasic insulin aspart 50

Formulation B

EXPERIMENTAL

Drug: biphasic insulin aspart 50

Interventions

biphasic insulin aspart 50 DRUG

A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-21days

Formulation A; Formulation B

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: February 7, 2012
• Study Start: November 16, 2002
• Primary Completion: January 8, 2003
• Study Completion: January 8, 2003
• Last Updated: February 24, 2017

Record last verified: 2017-02

Locations

JP (1)