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

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ClinicalTrials.gov Identifier: NCT01620437
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Healthy Drug: biphasic insulin aspart 50 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Actual Study Start Date : November 29, 2003
Actual Primary Completion Date : December 30, 2003
Actual Study Completion Date : December 30, 2003

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Area under the insulin aspart curve in the interval from 0-16 hours
  2. Cmax, maximum insulin aspart concentration

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


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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

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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01620437     History of Changes
Other Study ID Numbers: BIASP-1581
First Posted: June 15, 2012    Key Record Dates
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