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Completed

NCT Number: NCT01138488

A Trial Investigating the Total Exposure of NN5401 (Insulin Degludec/Insulin Aspart) in Children, Adolescents and Adult Subjects With Type 1 Diabetes

This trial was conducted in Europe. The aim of this study was to investigate the total exposure of NN5401 (insulin degludec/insulin aspart) in children, adolescents and adult subjects with type 1 diabetes.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Hanover, 30173, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Body mass index for children: 15.0-20.0 kg/m^2 (both inclusive), for adolescents: 18.0-28.0 kg/m^2 (both inclusive) and for adults maximum 30.0 kg/m^2

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
  • Not able or willing to refrain from smoking during the inpatient period
  • Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods

Treatment and study plan

insulin degludec/insulin aspart

Drug

Insulin degludec/insulin aspart administered as a single subcutaneous injection (under the skin).

Primary outcomes

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

    Time frame: from 0 to infinity after single-dose

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

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

Secondary outcomes

  1. Maximum observed insulin degludec concentration of NN5401 (insulin degludec/insulin aspart) observed

    Time frame: from 0 to 57 hours after single-dose

  2. Maximum observed insulin aspart concentration of NN5401 (insulin degludec/insulin aspart) observed

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Collaborators

  • HNEC TEST

Registry information

Official study title

A Trial Investigating the Pharmacokinetic Properties of NN5401 in Children, Adolescents and Adults With Type 1 Diabetes

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 7, 2010
Registry last updated
Feb 10, 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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