NCT01620333

Brief Summary

This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics of biphasic insulin aspart 50 (NN-X14Mix50) and biphasic insulin aspart 70 (NN-X14Mix70) in Japanese healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Feb 2000

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

February 1, 2000

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2000

Completed
12.2 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

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

June 13, 2012

Last Update Submit

January 4, 2017

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (1)

  • Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 70)

Secondary Outcomes (7)

  • Cmax, maximum insulin aspart concentration

  • tmax, time to maximum insulin aspart concentration

  • t½, terminal elimination half life

  • Mean residence time (MRT)

  • Area under the curve from time 0 to infinity (0-∞)

  • +2 more secondary outcomes

Study Arms (2)

Treatment period 1

EXPERIMENTAL
Drug: biphasic insulin aspart 50Drug: biphasic insulin aspart 70

Treatment period 2

EXPERIMENTAL
Drug: biphasic insulin aspart 50Drug: biphasic insulin aspart 70

Interventions

biphasic insulin aspart 50DRUG

A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days

Treatment period 1Treatment period 2
biphasic insulin aspart 70DRUG

A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days

Treatment period 1Treatment period 2

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Japanese
  • Body Mass Index (BMI) of 19-27 kg/m\^2 (both inclusive)
  • Fasting blood glucose between 3.8-6 mmol/L (68.4-108.0 mg/dL) (both inclusive
  • Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator

You may not qualify if:

  • Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator or Sub-Investigator(s)
  • Any serious systemic infectious disease that occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator
  • Any inter-current illness that may affect blood glucose, as judged by the Investigator or Sub-Investigator
  • Hepatitis B or C, or HIV (human immunodeficiency virus)
  • Use of prescription drugs within 2 weeks preceding the screening
  • Use of non-prescription drugs, except routine vitamins or drugs that may not
  • Blood donation of more than 1150 mL within the last 12 months
  • Subjects with a first degree relative with diabetes mellitus
  • History of or presence of diabetes
  • History of or presence of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder
  • Previous history of serious allergy or anaphylactic reaction
  • Subjects who consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse
  • Subjects who smoke more than 5 cigarettes per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Related Publications (2)

  • Irie S, Furuie H, Matsuguma K, Matsumura Y. Pharmacokinetics and pharmacodynamics of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy Japanese subjects. Diabetologia 2006; 49 (Suppl 1): 612

    RESULT

  • Irie S, Matsumura Y, Furuie H, Matsuguma K. Comparison of the pharmacokinetic and pharmacodynamic properties of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy Japanese. Diabetic Medicine 2006; 23 (Suppl 4): 331 (P915)

    RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

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
NONE
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

February 1, 2000

Primary Completion

April 1, 2000

Study Completion

April 1, 2000

Last Updated

January 5, 2017

Record last verified: 2017-01

Locations

JP(1)