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

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ClinicalTrials.gov Identifier: NCT02844790
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: insulin degludec/insulin aspart Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart in Healthy Chinese Subjects
Actual Study Start Date : July 25, 2016
Actual Primary Completion Date : September 26, 2016
Actual Study Completion Date : September 26, 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: IDegAsp Drug: insulin degludec/insulin aspart
A single dose of IDegAsp will be administered subcutaneously (s.c., under the skin).


Outcome Measures
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Primary Outcome Measures :
  1. Area under the serum insulin degludec concentration-time curve [ Time Frame: From 0 to 120 hours after single dose ]
  2. Area under the serum insulin aspart concentration-time curve [ Time Frame: From 0 to 12 hours after single dose ]

Secondary Outcome Measures :
  1. Maximum observed serum insulin degludec concentration [ Time Frame: After single dose (within 0 to 120 hours after dosing) ]
  2. Maximum observed serum insulin aspart concentration [ Time Frame: After single dose (within 0 to 12 hours after dosing) ]
  3. Time to maximum observed serum insulin degludec concentration [ Time Frame: After single dose (within 0 to 120 hours after dosing) ]
  4. Time to maximum observed serum insulin aspart concentration [ Time Frame: After single dose (within 0 to 12 hours after dosing) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • Smoking more than 5 cigarettes (including nicotine substitute products), or the equivalent, per
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844790


Locations
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China
Novo Nordisk Investigational Site
Beijing, China, 100730
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02844790     History of Changes
Other Study ID Numbers: NN5401-1984
U1111-1173-7678 ( Other Identifier: WHO )
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
 Insulin degludec, insulin aspart drug combination
Hypoglycemic Agents
Physiological Effects of Drugs