Pharmacokinetics of Insulin Detemir in Healthy Volunteers From Taiwan

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: December 20, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
This trial is conducted in Asia. The aim of this trial is to investigate pharmacokinetics of insulin detemir in healthy Taiwanese subjects.

Condition Intervention Phase
Drug: insulin detemir
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Centre, Open-labelled Trial to Investigate the Pharmacokinetics of Insulin Detemir in Healthy Taiwanese Subjects

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the insulin detemir concentration curve

Secondary Outcome Measures:
  • Maximum insulin detemir concentration
  • Time to maximum insulin detemir concentration
  • The mean residence time of insulin detemir
  • Insulin detemir half-life

Enrollment: 20
Study Start Date: August 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin detemir Drug: insulin detemir
Single dose, 0.5 U/kg, administered s.c. (under the skin)


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01497587

Taipei, Taiwan, 112
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Jessie Wu Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT01497587     History of Changes
Other Study ID Numbers: NN304-3023 
Study First Received: December 20, 2011
Last Updated: December 20, 2011

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on January 19, 2017