A Trial Investigating the Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart in Healthy Chinese Subjects

This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) properties of insulin degludec/insulin aspart in healthy Chinese subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: insulin degludec/insulin aspart

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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
• Smoking more than 5 cigarettes (including nicotine substitute products), or the equivalent, per

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDegAsp	Drug: insulin degludec/insulin aspart; A single dose of IDegAsp will be administered subcutaneously (s.c., under the skin).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the serum insulin degludec concentration-time curve	From 0 to 120 hours after single dose
Area under the serum insulin aspart concentration-time curve	From 0 to 12 hours after single dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed serum insulin degludec concentration	After single dose (within 0 to 120 hours after dosing)
Maximum observed serum insulin aspart concentration	After single dose (within 0 to 12 hours after dosing)
Time to maximum observed serum insulin degludec concentration	After single dose (within 0 to 120 hours after dosing)
Time to maximum observed serum insulin aspart concentration	After single dose (within 0 to 12 hours after dosing)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• Aixin S, Yang L, Panpan X, Qi W , Lei Y, Hongfei X, Ran LZ, Haahr H. A study investigating the pharmacokinetic properties of insulin degludec/insulin aspart in healthy Chinese subjects. Diabetes Manag. 2019; 9 (2): 48-56.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2016
• Primary Completion (Actual): September 26, 2016
• Study Completion (Actual): September 27, 2016

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin Aspart
• Other Study ID Numbers: NN5401-1984; U1111-1173-7678 (Other Identifier: WHO)