Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects

NCT ID: NCT01437592

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-06
• Study Completion Date: 2011-11-22

Brief Summary

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.

Conditions

Diabetes; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IDeg

Group Type: EXPERIMENTAL

insulin degludec

Intervention Type: DRUG

For each subject, a single dose of NN1250 will be administered subcutaneously (under the skin)

Interventions

insulin degludec

For each subject, a single dose of NN1250 will be administered subcutaneously (under the skin)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Countries

China

References

Pei H, Jiang J, Bardtrum L, Haahr H. Pharmacokinetic properties of insulin degludec in healthy Chinese subjects. Diabetes Manag 2019;9(1):20-7

Reference Type: BACKGROUND

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

U1111-1122-6475

Identifier Type: OTHER

Identifier Source: secondary_id

NN1250-1999

Identifier Type: -

Identifier Source: org_study_id