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Completed

NCT Number: NCT00567775

Comparison of Human Insulin to Insulin Inhalation Solution in Children With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the pharmacokinetic profile of two different methods of insulin administration in children 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–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site

Glostrup Municipality, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 diabetes
  • Treatment for at least 12 months
  • HbA1c lesser or equal to 11.0%
  • Body weight between 25 and 80 Kg
  • Capable to use the device

Exclusion criteria

  • Any diseases other than diabetes requiring prescriptive medication
  • Known or suspected allergy to trial product or related products
  • Active proliferative retinopathy as judged by the Investigator
  • Recurrent severe hypoglycaemia as judged by the Investigator
  • The receipt of any investigational drug within 4 weeks prior to this trial

Treatment and study plan

human insulin

Drug

Other names: Actrapid®, Novolin® R

inhaled human insulin

Drug

Primary outcomes

  1. Area under the serum insulin curve

    Time frame: from 0 to 5 hours post-dosing

Secondary outcomes

  1. Maximum serum insulin concentration

    Time frame: in the interval from 0 to 5 hours post-dosing

  2. Time to maximum serum insulin concentration

    Time frame: in the interval from 0 to 5 hours post-dosing

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Comparison of Pharmacokinetic Profiles of Human Soluble Insulin With Insulin Inhalation Solution in Paediatric Type 1 Diabetes Mellitus

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Dec 5, 2007
Registry last updated
Mar 1, 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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