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NCT Number: NCT01125553

A Comparison Between Two Formulations of NN5401 in Healthy Subjects

This trial is conducted in the United States of America (USA). The aim of the trial is to compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) 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 Clinical Trial Call Center

Chula Vista, California, 91911, 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 electrocardiogram (ECG), as judged by the physician
  • Body mass index between 18.0 and 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 trial start
  • 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/insulin aspart

Drug

Each subject will be allocated to two single injections of trial product on two separate dosing visits with each of the two insulin degludec/insulin aspart formulations. The trial products will be administered as a subcutaneous injection (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

  2. Maximum observed serum insulin degludec concentration

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

  3. Area under the serum insulin aspart concentration-time curve

    Time frame: from 0 to 12 hours after single-dose

  4. Maximum observed serum insulin aspart concentration

    Time frame: from 0 to 12 hours after single-dose

Secondary outcomes

  1. Time to maximum observed serum insulin degludec concentration

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

  2. Time to maximum observed serum insulin aspart concentration

    Time frame: from 0 to 12 hours after single-dose

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial to Test for Bioequivalence Between Two NN5401 Formulations in Healthy Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 18, 2010
Registry last updated
Sep 25, 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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