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Completed

NCT Number: NCT01151072

A Trial Comparing the Effect of NN1250 After Different Routes of Injection in Healthy Subjects

This trial was conducted in Europe. The aim of this clinical trial was to compare the exposure and effect of NN1250 (insulin degludec) after different routes of injection 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

Novo Nordisk Investigational Site

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, 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

Each subject was randomly allocated to five single dose administrations of NN1250 subcutaneously (under the skin) in the thigh, the abdomen (stomach) and the deltoid (shoulder), intramuscularly (into the muscle) in the thigh and intravenously (into the vein), respectively, on five separate dosing visits.

Primary outcomes

  1. Area under the serum Insulin Degludec concentration-time curve (only for subcutaneous administration)

    Time frame: From 0 to 120 hours after single-dose

Secondary outcomes

  1. Area under the serum Insulin Degludec concentration-time curve (only for intramuscular administration)

    Time frame: From 0 to 120 hours after single-dose

  2. Area under the serum Insulin Degludec concentration-time curve (only for intravenous administration)

    Time frame: From 0 to 30 hours after single-dose

  3. Maximum observed serum Insulin Degludec concentration after single-dose (only for subcutaneous and intramuscular administration)

    Time frame: Within 0 to 120 hours after dosing

  4. Back-extrapolated initial serum Insulin Degludec concentration after single-dose (only for intravenous administration)

    Time frame: At time zero after dosing

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties of NN1250 After Different Routes of Administration in Healthy Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 25, 2010
Registry last updated
Jan 20, 2017

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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