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
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
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014