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

Tracking Information

First Received Date ^ICMJE

December 20, 2011

Last Updated Date

December 20, 2011

Start Date ^ICMJE

August 2005

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Area under the insulin detemir concentration curve [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pharmacokinetics of Insulin Detemir in Healthy Volunteers From Taiwan

Official Title ^ICMJE

A Single Centre, Open-labelled Trial to Investigate the Pharmacokinetics of Insulin Detemir in Healthy Taiwanese Subjects

Brief Summary

This trial is conducted in Asia. The aim of this trial is to investigate pharmacokinetics of insulin detemir in healthy Taiwanese subjects.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes
Healthy

Intervention ^ICMJE

Drug: insulin detemir

Single dose, 0.5 U/kg, administered s.c. (under the skin)

Study Arm (s)

Experimental: Insulin detemir

Intervention: Drug: insulin detemir

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2005

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT01497587

Other Study ID Numbers ^ICMJE

NN304-3023

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Jessie Wu

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top