Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects

Healthy Clinical Trial

Official title:

A Trial Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437592
• Other study ID #: NN1250-1999
• Secondary ID: U1111-1122-6475
• Status: Completed
• Phase: Phase 1
• Start date: September 6, 2011
• Est. completion date: November 22, 2011

Study information

• Verified date: May 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 22, 2011
• Est. primary completion date: November 22, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• insulin degludec
For each subject, a single dose of NN1250 will be administered subcutaneously (under the skin)

Locations

Country	Name	City	State
China	Novo Nordisk Investigational Site	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum insulin degludec concentration-time curve		From 0 to 120 hours after single dose
Secondary	Maximum observed serum insulin degludec concentration		0-24 hours (derived on treatment day 1).
Secondary	Time to maximum observed serum insulin degludec concentration		0-24 hours (derived on treatment day 1).

External Links

•   Clinical Trials at Novo Nordisk