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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01527630
First received: February 2, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 50
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Single-centre, Two-Period Crossover Trial Testing the Bioequivalence of Two Formulations of NN-X14Mix50 in Healthy Japanese Subjects

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the insulin aspart concentration-time curve in the interval from 0 to 16 hours [ Designated as safety issue: No ]
  • Cmax, maximum insulin aspart concentration [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the insulin aspart concentration-time curve [ Designated as safety issue: No ]
  • Tmax, time to maximum insulin aspart concentration [ Designated as safety issue: No ]
  • MRT, mean residence time [ Designated as safety issue: No ]
  • t½, terminal half-life [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2002
Study Completion Date: January 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation A Drug: biphasic insulin aspart 50
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
Experimental: Formulation B Drug: biphasic insulin aspart 50
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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527630

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Hiromasa Ono Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01527630     History of Changes
Other Study ID Numbers: BIASP-1504
Study First Received: February 2, 2012
Last Updated: February 2, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin Aspart
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014