Pharmacokinetics of Insulin Detemir in Healthy Volunteers From Taiwan

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01497587

Enrollment

Registered

2011-12-22

Start date

2005-08-31

Completion date

2005-12-31

Last updated

2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

Brief summary

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

Interventions

DRUGinsulin detemir

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Area under the insulin detemir concentration curve	—

Secondary

Measure	Time frame
Maximum insulin detemir concentration	—
Time to maximum insulin detemir concentration	—
The mean residence time of insulin detemir	—
Insulin detemir half-life	—

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026