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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00567775
First received: November 30, 2007
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

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
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
  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00567775

Locations
Denmark
Glostrup, Denmark, 2600
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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
ClinicalTrials.gov 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
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014