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OpenTrials
Completed

NCT Number: NCT00966368

Comparison of Two NN1250 Formulations in Healthy Volunteers

This trial was conducted in North America. The aim of this clinical trial was to investigate if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the body.

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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 Clinical Trial Call Center

Chula Vista, California, 91911-1350, United States

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

Single dose of NN1250, formulation 1, 0.4U/kg body weight injected subcutaneously (under the skin)

Primary outcomes

  1. Area under the Insulin Degludec concentration-time curve from 0 to 120 hours after single dose

    Time frame: From 0 to 120 hours after dosing

  2. Maximum observed Insulin Degludec concentration after single dose

    Time frame: From 0 to 120 hours after dosing

Secondary outcomes

  1. Time to maximum observed Insulin Degludec concentration after single dose

    Time frame: From 0 to 120 hours after dosing

  2. Area under the Insulin Degludec concentration-time curve from 0 to 24 hours after single dose

    Time frame: From 0-24 hours after dosing

  3. Terminal half-life for Insulin Degludec

    Time frame: From 0 to 120 hours after dosing

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial to Test for Bioequivalence Between Two NN1250 Formulations in Healthy Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 26, 2009
Registry last updated
Sep 28, 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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