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Pharmacokinetics of Insulin Detemir in Healthy Volunteers From Taiwan

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01497587
First received: December 20, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  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
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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497587

Locations
Taiwan
Taipei, Taiwan, 112
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Jessie Wu Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov 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
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013