Pharmacokinetics of Insulin Detemir in Healthy Volunteers From Taiwan

Healthy Clinical Trial

Official title:

A Single Centre, Open-labelled Trial to Investigate the Pharmacokinetics of Insulin Detemir in Healthy Taiwanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497587
• Other study ID #: NN304-3023
• Status: Completed
• Phase: Phase 1
• First received: December 20, 2011
• Last updated: January 30, 2017
• Start date: August 2005
• Est. completion date: December 2005

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• insulin detemir
Single dose, 0.5 U/kg, administered s.c. (under the skin)

Locations

Country	Name	City	State
Taiwan	Novo Nordisk Investigational Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Taiwan, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the insulin detemir concentration curve
Secondary	Maximum insulin detemir concentration
Secondary	Time to maximum insulin detemir concentration
Secondary	The mean residence time of insulin detemir
Secondary	Insulin detemir half-life

External Links

•   Clinical Trials at Novo Nordisk