This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Pharmacokinetics of Insulin Detemir in Healthy Chinese Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01498939
First received: December 21, 2011
Last updated: October 27, 2016
Last verified: October 2016
  Purpose
This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetics after a single dose of insulin detemir in healthy Chinese male subjects.

Condition Intervention Phase
Diabetes Healthy Drug: insulin detemir Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single Centre, Randomised, Double-blind, Three-period Cross-over Trial to Investigate the 24-hour Pharmacokinetics After Single Dose of Insulin Detemir in Healthy Chinese Male 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 [ Time Frame: from time zero to 24 hour ]

Secondary Outcome Measures:
  • Area under the insulin detemir concentration curve
  • Maximum serum insulin detemir concentration
  • Time to maximum serum insulin detemir concentration
  • Mean residence time (MRT)
  • Terminal half-life
  • Insulin detemir clearance
  • Adverse events

Enrollment: 20
Study Start Date: August 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDet 0.2 U/kg Drug: insulin detemir
Each subject will be randomly allocated to an insulin detemir dosing sequence. Three doses of insulin detemir (0.2, 0.4 or 0.8 U/kg) will be administered on three inconsecutive days with a wash-out period between each dosing. Injected subcutaneously (s.c., under the skin)
Experimental: IDet 0.4 U/kg Drug: insulin detemir
Each subject will be randomly allocated to an insulin detemir dosing sequence. Three doses of insulin detemir (0.2, 0.4 or 0.8 U/kg) will be administered on three inconsecutive days with a wash-out period between each dosing. Injected subcutaneously (s.c., under the skin)
Experimental: IDet 0.8 U/kg Drug: insulin detemir
Each subject will be randomly allocated to an insulin detemir dosing sequence. Three doses of insulin detemir (0.2, 0.4 or 0.8 U/kg) will be administered on three inconsecutive days with a wash-out period between each dosing. Injected subcutaneously (s.c., under the skin)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index (BMI) between 18 and 25 kg/m^2 (both inclusive)
  • Fasting plasma glucose maximum 6 mmol/L
  • Non-smoker
  • Considered generally healthy upon completion of medical history, physical examination and laboratory assessments, as judged by the Investigator

Exclusion Criteria:

  • Known or suspected allergy to trial product(s) or related products
  • Previous participation in this trial. Participation is defined as randomisation
  • Receipt of any investigational drug within the last three months prior to this trial
  • History of alcohol or drug abuse
  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 ClinicalTrials.gov identifier: NCT01498939

Locations
China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100032
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01498939     History of Changes
Other Study ID Numbers: NN304-1889
Study First Received: December 21, 2011
Last Updated: October 27, 2016

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

ClinicalTrials.gov processed this record on June 21, 2017