Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes
December 20, 2016 updated by: Novo Nordisk A/S
Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes Mellitus
This trial is conducted in Europe.
The aim of this trial is to investigate the efficacy of insulin aspart compared to soluble human insulin on blood glucose control in children below 7 years of age with type 1 diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bialystok, Poland, 15-274
- Novo Nordisk Investigational Site
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Gliwice, Poland, 44-100
- Novo Nordisk Investigational Site
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Kielce, Poland, 25-734
- Novo Nordisk Investigational Site
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Krakow, Poland, 30-663
- Novo Nordisk Investigational Site
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Warszawa, Poland, 01-184
- Novo Nordisk Investigational Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 7 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 1 diabetes for at least 1 year
- HbA1c below 12.0%
- Treatment with regular human insulin and insulin NPH for at least 1 month
- Receive more than 2 injections daily
Exclusion Criteria:
- Receipt of investigational product within 6 months prior to trial participation
- Known or suspected allergy to investigational product
- Receipt of of insulin aspart within 3 months prior to trial participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
HbA1c
Time Frame: after 26 weeks of treatment
|
after 26 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Occurrence of adverse events
|
|
Occurrence of serious adverse events
|
|
Overall glycaemic control
|
|
Frequency of hypoglycaemia episodes
|
|
Quality of Life (QoL)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2003
Primary Completion (Actual)
October 1, 2004
Study Completion (Actual)
October 1, 2004
Study Registration Dates
First Submitted
December 11, 2007
First Submitted That Met QC Criteria
December 11, 2007
First Posted (Estimate)
December 12, 2007
Study Record Updates
Last Update Posted (Estimate)
December 21, 2016
Last Update Submitted That Met QC Criteria
December 20, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANA-1507
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.