Pharmacokinetics of Insulin Detemir in Healthy Volunteers From Taiwan

Phase 1

Completed

• Conditions: Healthy; Diabetes
• Interventions: Drug: insulin detemir

• Registration Number: NCT01497587
• Lead Sponsor: Novo Nordisk A/S

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 available

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-22
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insulin detemir	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Area under the insulin detemir concentration curve

Secondary Outcome Measures

Name	Time	Method
Maximum insulin detemir concentration
Time to maximum insulin detemir concentration
Insulin detemir half-life
The mean residence time of insulin detemir

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇳 Taipei, Taiwan