Pharmacokinetics of Insulin Detemir in Healthy Volunteers From Taiwan

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01497587

NN304-3023

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Insulin detemir

Experimental group

Treatment:

Drug: insulin detemir