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Pharmacokinetics of Insulin Detemir in Healthy Volunteers From Taiwan

Phase 1
Completed
Conditions
Healthy
Diabetes
Interventions
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

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
GroupInterventionDescription
Insulin detemirinsulin detemir-
Primary Outcome Measures
NameTimeMethod
Area under the insulin detemir concentration curve
Secondary Outcome Measures
NameTimeMethod
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

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