NCT01620437

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Nov 2003

Shorter than P25 for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2003

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2003

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

1 month

First QC Date

June 13, 2012

Last Update Submit

February 22, 2017

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (2)

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

  • Cmax, maximum insulin aspart concentration

Secondary Outcomes (5)

  • tmax, time to maximum insulin aspart concentration

  • Area under the insulin aspart curve

  • Mean residence time (MRT)

  • t½, terminal half-life

  • Adverse events

Study Arms (2)

Formulation A

EXPERIMENTAL
Drug: biphasic insulin aspart 50

Formulation B

EXPERIMENTAL
Drug: biphasic insulin aspart 50

Interventions

biphasic insulin aspart 50DRUG

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

Formulation AFormulation B

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects with a first-degree relative with diabetes mellitus
  • Subjects smoke 5 cigarettes or more per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine 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

June 13, 2012

First Posted

June 15, 2012

Study Start

November 29, 2003

Primary Completion

December 30, 2003

Study Completion

December 30, 2003

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

JP(1)