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Pharmacokinetics of Insulin Detemir in Healthy Volunteers From Taiwan

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: December 20, 2011
Last updated: January 30, 2017
Last verified: January 2017
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
Diabetes Healthy Drug: insulin detemir Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
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
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Please refer to this study by its identifier: NCT01497587

Novo Nordisk Investigational Site
Taipei, Taiwan, 112
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
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

Responsible Party: Novo Nordisk A/S Identifier: NCT01497587     History of Changes
Other Study ID Numbers: NN304-3023
Study First Received: December 20, 2011
Last Updated: January 30, 2017

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on July 27, 2017