Pharmacokinetics of Insulin Detemir in Healthy Chinese Male Subjects

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01498939
First received: December 21, 2011
Last updated: December 28, 2011
Last verified: December 2011
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the insulin detemir concentration curve [ Designated as safety issue: No ]
  • Maximum serum insulin detemir concentration [ Designated as safety issue: No ]
  • Time to maximum serum insulin detemir concentration [ Designated as safety issue: No ]
  • Mean residence time (MRT) [ Designated as safety issue: No ]
  • Terminal half-life [ Designated as safety issue: No ]
  • Insulin detemir clearance [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

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
Genders 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
Beijing, Beijing, China, 100032
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Jin Pingping Novo Nordisk (China) Pharmaceutical Co. Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, 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: December 28, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014