Back to resultsEfficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
insulin aspart
soluble human insulin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
HbA1c
Secondary Outcome Measures
Overall glycaemic control
Occurrence of adverse events
Occurrence of serious adverse events
Frequency of hypoglycaemia episodes
Quality of Life (QoL)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00571935
Brief Title
Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes
Official Title
Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (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 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.
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 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Type
Drug
Intervention Name(s)
soluble human insulin
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
after 26 weeks of treatment
Secondary Outcome Measure Information:
Title
Overall glycaemic control
Title
Occurrence of adverse events
Title
Occurrence of serious adverse events
Title
Frequency of hypoglycaemia episodes
Title
Quality of Life (QoL)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Bialystok
ZIP/Postal Code
15-274
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Gliwice
ZIP/Postal Code
44-100
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Krakow
ZIP/Postal Code
30-663
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
01-184
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
20388052
Citation
Pankowska E, Nazim J, Szalecki M, Urban M. Equal metabolic control but superior caregiver treatment satisfaction with insulin aspart in preschool children. Diabetes Technol Ther. 2010 May;12(5):413-8. doi: 10.1089/dia.2009.0155.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes
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