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Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01437592
First received: September 9, 2011
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Diabetes
Healthy
Drug: insulin degludec
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the serum insulin degludec concentration-time curve [ Time Frame: From 0 to 120 hours after single dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum observed serum insulin degludec concentration [ Time Frame: 0-24 hours (derived on treatment day 1). ] [ Designated as safety issue: No ]
  • Time to maximum observed serum insulin degludec concentration [ Time Frame: 0-24 hours (derived on treatment day 1). ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg Drug: insulin degludec
For each subject, a single dose of NN1250 will be administered subcutaneously (under the skin)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437592

Locations
China, Beijing
Beijing, Beijing, China, 100032
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Hanne Hastrup-Nielsen Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01437592     History of Changes
Other Study ID Numbers: NN1250-1999, U1111-1122-6475
Study First Received: September 9, 2011
Last Updated: November 20, 2013
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on November 20, 2014