Back to resultsComparison of Human Insulin to Insulin Inhalation Solution in Children With Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
human insulin
inhaled human insulin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility 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
Sites / Locations
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Area under the serum insulin curve
Secondary Outcome Measures
Maximum serum insulin concentration
Time to maximum serum insulin concentration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00567775
Brief Title
Comparison of Human Insulin to Insulin Inhalation Solution in Children With Type 1 Diabetes
Official Title
Comparison of Pharmacokinetic Profiles of Human Soluble Insulin With Insulin Inhalation Solution in Paediatric Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 21, 2002 (Actual)
Primary Completion Date
November 20, 2002 (Actual)
Study Completion Date
November 20, 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
human insulin
Other Intervention Name(s)
Actrapid®, Novolin® R
Intervention Type
Drug
Intervention Name(s)
inhaled human insulin
Primary Outcome Measure Information:
Title
Area under the serum insulin curve
Time Frame
from 0 to 5 hours post-dosing
Secondary Outcome Measure Information:
Title
Maximum serum insulin concentration
Time Frame
in the interval from 0 to 5 hours post-dosing
Title
Time to maximum serum insulin concentration
Time Frame
in the interval from 0 to 5 hours post-dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Comparison of Human Insulin to Insulin Inhalation Solution in Children With Type 1 Diabetes
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