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Completed

NCT Number: NCT01623375

A Trial Investigating the Absolute Bioavailability of Insulin Degludec in Healthy Subjects

This trial is conducted in Europe. The aim of the trial is to investigate the absolute bioavailability of insulin degludec (IDeg) in healthy 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–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Considered generally healthy upon completion of medical history, physical examination, analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
  • Body mass index 18.0-27.0 kg/m^2 (both inclusive)

Exclusion criteria

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
  • Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Treatment and study plan

insulin degludec

Drug

A single dose of 0.4 U/kg body weight will be administered subcutaneously (s.c., under the skin).

Primary outcomes

  1. Area under the serum insulin degludec concentration-of s.c. administration

    Time frame: From 0 to infinity after single dose

  2. Area under the serum insulin degludec concentration-of i.v. administration

    Time frame: From 0 to infinity after single dose

Secondary outcomes

  1. Terminal half-life for insulin degludec

    Time frame: From 0 to 30 hours after single dose

  2. Volume of distribution of insulin degludec, estimated during the terminal phase

    Time frame: From 0 to 30 hours after single dose

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 20, 2012
Registry last updated
Feb 19, 2015

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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