Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: insulin degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT01437592

U1111-1122-6475 (Other Identifier)

NN1250-1999

Details and patient eligibility

About

This trial was conducted in Asia. The aim of this trial was to investigate the pharmacokinetic properties (the effect of the investigated drug on the body) of NN1250 (insulin degludec) in healthy Chinese subjects.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female Chinese subject aged 18-45 years (both inclusive)
• Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator
• Body mass index 19.0-24.0 kg/m^2 (both inclusive)

Exclusion criteria

• A history of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial product to the subject
• Subject who has donated any blood or plasma in the past month or more than 400 mL within 3 months prior to screening
• Not able or willing to refrain from smoking during the inpatient period

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

IDeg

Experimental group

Treatment:

Drug: insulin degludec