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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01620437
First Posted: June 15, 2012
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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 Healthy Drug: biphasic insulin aspart 50 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 curve in the interval from 0-16 hours
  • Cmax, maximum insulin aspart concentration

Secondary Outcome Measures:
  • tmax, time to maximum insulin aspart concentration
  • Area under the insulin aspart curve
  • Mean residence time (MRT)
  • t½, terminal half-life
  • Adverse events

Enrollment: 30
Actual Study Start Date: November 29, 2003
Study Completion Date: December 30, 2003
Primary Completion Date: December 30, 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation A Drug: biphasic insulin aspart 50
A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-21 days will take place between dosing visits
Experimental: Formulation B Drug: biphasic insulin aspart 50
A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-21 days will take place between dosing visits

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620437


Locations
Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01620437     History of Changes
Other Study ID Numbers: BIASP-1581
First Submitted: June 13, 2012
First Posted: June 15, 2012
Last Update Posted: February 24, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs