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Pharmacokinetics of Insulin Detemir in Healthy Volunteers From Taiwan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01497587
First Posted: December 22, 2011
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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: None (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)

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497587


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

Additional Information:
Publications:
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
ClinicalTrials.gov Identifier: NCT01497587     History of Changes
Other Study ID Numbers: NN304-3023
First Submitted: December 20, 2011
First Posted: December 22, 2011
Last Update Posted: January 31, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs