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Completed

NCT Number: NCT01590836

A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic response (the effect of the investigated drug on the body) of insulin degludec/insulin aspart (IDegAsp) at steady state in 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

18 year–65 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: 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
  • Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
  • Body mass index (BMI) 18.0-28.0 kg/m^2 (both inclusive)
  • Glycosylated haemoglobin (HbA1c) maximum 9.5 %
  • Fasting C-peptide maximum 0.3 nmol/L

Exclusion criteria

  • 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, use of nicotine gum or transdermal nicotine patches during the inpatient period
  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening

Treatment and study plan

insulin degludec

Drug

Administered subcutaneously (s.c., under the skin) once daily (plus insulin aspart as bolus insulin as required).

insulin degludec/insulin aspart

Drug

Single dose administered subcutaneously (s.c., under the skin).

Primary outcomes

  1. Area under the glucose infusion rate curve during one dosing interval

    Time frame: At steady state (0-24 hours)

Secondary outcomes

  1. Maximum glucose infusion rate (GIRmax)

    Time frame: At steady state (within 0-24 hours after last dosing)

  2. Area under the serum insulin degludec concentration-time curve during one dosing interval

    Time frame: At steady state (within 0-24 hours after last dosing)

  3. Maximum observed serum insulin degludec concentration

    Time frame: At steady state (within 0-24 hours after last dosing)

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

    Time frame: From 0 to 12 hours

  5. Maximum observed serum insulin aspart concentration

    Time frame: Within 0-12 hours after dosing of IDegAsp

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
May 3, 2012
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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