NCT01497587

Brief Summary

This trial is conducted in Asia. The aim of this trial is to investigate pharmacokinetics of insulin detemir in healthy Taiwanese subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Aug 2005

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

August 1, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2011

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

December 20, 2011

Last Update Submit

January 30, 2017

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (1)

  • Area under the insulin detemir concentration curve

Secondary Outcomes (4)

  • Maximum insulin detemir concentration

  • Time to maximum insulin detemir concentration

  • The mean residence time of insulin detemir

  • Insulin detemir half-life

Study Arms (1)

Insulin detemir

EXPERIMENTAL
Drug: insulin detemir

Interventions

insulin detemirDRUG

Single dose, 0.5 U/kg, administered s.c. (under the skin)

Insulin detemir

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Considered generally healthy upon completion of medical history and physical examination as judged by the investigator
  • Body mass index (BMI) between 18 and 27 kg/m\^2, inclusive
  • Fasting plasma glucose maximum 6.1 mmol/l
  • Non-smoker or smoking maximum 5 cigarettes per day or the equivalent

You may not qualify if:

  • Participation in any other clinical trial involving other investigational products within the last 3 months
  • Subject with a history of alcohol or drug dependence
  • Subject with a first-degree relative with diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Taipei, 112, Taiwan

Location

Related Publications (1)

  • Kwok C-F, Tsai T-H, Lim S-H, Vaz J, Ho L-T. The Pharmacokinetic Profile of Insulin Detemir in Healthy Male Taiwanese and Caucasian Subjects. ASEAN Federation of Endocrine Societies (AFES); Country: Malaysia City: Kuala Lumpur

    RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 22, 2011

Study Start

August 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

TW(1)