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

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: November 30, 2007
Last updated: July 9, 2012
Last verified: July 2012
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.

Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: human insulin
Drug: inhaled human insulin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Pharmacokinetic Profiles of Human Soluble Insulin With Insulin Inhalation Solution in Paediatric Type 1 Diabetes Mellitus

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the serum insulin curve [ Time Frame: from 0 to 5 hours post-dosing ]

Secondary Outcome Measures:
  • Maximum serum insulin concentration [ Time Frame: in the interval from 0 to 5 hours post-dosing ]
  • Time to maximum serum insulin concentration [ Time Frame: in the interval from 0 to 5 hours post-dosing ]

Enrollment: 27
Study Start Date: October 2002
Study Completion Date: November 2002
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: human insulin
    Other Names:
    • Actrapid®
    • Novolin® R
    Drug: inhaled human insulin

Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00567775

Glostrup, Denmark, 2600
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Birgitte Scharling, MSc Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT00567775     History of Changes
Other Study ID Numbers: NN1998-1274 
Study First Received: November 30, 2007
Last Updated: July 9, 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on February 24, 2017