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Completed

NCT Number: NCT01437592

Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, 100032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin degludec

Drug

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

Primary outcomes

  1. Area under the serum insulin degludec concentration-time curve

    Time frame: From 0 to 120 hours after single dose

Secondary outcomes

  1. Maximum observed serum insulin degludec concentration

    Time frame: 0-24 hours (derived on treatment day 1).

  2. Time to maximum observed serum insulin degludec concentration

    Time frame: 0-24 hours (derived on treatment day 1).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 21, 2011
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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