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
Endpoint Classification: Bio-availability Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum serum insulin concentration [ Time Frame: in the interval from 0 to 5 hours post-dosing ] [ Designated as safety issue: No ]
  • Time to maximum serum insulin concentration [ Time Frame: in the interval from 0 to 5 hours post-dosing ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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:
No publications provided

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
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 17, 2014