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
Endpoint Classification: Pharmacokinetics Study
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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum insulin detemir concentration [ Designated as safety issue: No ]
  • Time to maximum insulin detemir concentration [ Designated as safety issue: No ]
  • The mean residence time of insulin detemir [ Designated as safety issue: No ]
  • Insulin detemir half-life [ Designated as safety issue: No ]

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
Genders 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
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:
No publications provided

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
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 17, 2014