Pharmacokinetics of Insulin Detemir in Healthy Chinese Male Subjects

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01498939

NN304-1889

Details and patient eligibility

About

This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetics after a single dose of insulin detemir in healthy Chinese male subjects.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) between 18 and 25 kg/m^2 (both inclusive)
• Fasting plasma glucose maximum 6 mmol/L
• Non-smoker
• Considered generally healthy upon completion of medical history, physical examination and laboratory assessments, as judged by the Investigator

Exclusion criteria

• Known or suspected allergy to trial product(s) or related products
• Previous participation in this trial. Participation is defined as randomisation
• Receipt of any investigational drug within the last three months prior to this trial
• History of alcohol or drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 3 patient groups

IDet 0.2 U/kg

Experimental group

Treatment:

Drug: insulin detemir

IDet 0.4 U/kg

Experimental group

Treatment:

Drug: insulin detemir

IDet 0.8 U/kg

Experimental group

Treatment:

Drug: insulin detemir