Back to resultsSafety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
insulin aspart
human insulin
isophane human insulin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Type 1 diabetes
- Treatment with insulin for at least 6 months prior to inclusion
- HbA1c below or equal to 11.0 %
- Currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion
Exclusion Criteria:
- The receipt of any investigational drug within one month prior to this trial
- Recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator
- Total daily insulin doses at least 1.80 IU/kg
- Treatment with oral hypoglycaemic agents
- Known or suspected allergy to trial product or related products
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IAsp
HI
Arm Description
Outcomes
Primary Outcome Measures
Incidence of hypoglycaemic episodes during the treatment
Change in HbA1c (glycosylated haemoglobin A1c)
Secondary Outcome Measures
Incidence of Adverse Events (AEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01467141
Brief Title
Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes
Official Title
Meal-related Insulin Aspart Therapy Versus Meal-related Human Insulin Therapy in Children 2-6 Years of Age With Type 1 Diabetes Mellitus: A Multi-centre Randomised, Open-labelled, Cross-over, Safety and Efficacy Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 19, 2002 (Actual)
Primary Completion Date
October 15, 2003 (Actual)
Study Completion Date
October 15, 2003 (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 evaluate safety and efficacy 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 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IAsp
Arm Type
Experimental
Arm Title
HI
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Injected s.c. (under the skin) three times a day
Intervention Type
Drug
Intervention Name(s)
human insulin
Intervention Description
Injected s.c. (under the skin) 30 minutes before the meals
Intervention Type
Drug
Intervention Name(s)
isophane human insulin
Intervention Description
May be administered s.c. (under the skin) in both treatment groups thrice daily
Primary Outcome Measure Information:
Title
Incidence of hypoglycaemic episodes during the treatment
Time Frame
Week 0; week 24
Title
Change in HbA1c (glycosylated haemoglobin A1c)
Time Frame
Week 0; week 24
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events (AEs)
Time Frame
Week 0; week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 1 diabetes
Treatment with insulin for at least 6 months prior to inclusion
HbA1c below or equal to 11.0 %
Currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion
Exclusion Criteria:
The receipt of any investigational drug within one month prior to this trial
Recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator
Total daily insulin doses at least 1.80 IU/kg
Treatment with oral hypoglycaemic agents
Known or suspected allergy to trial product or related products
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
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hagen
ZIP/Postal Code
58095
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
22149
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Osnabrück
ZIP/Postal Code
49082
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
17850471
Citation
Danne T, Rastam J, Odendahl R, Nake A, Schimmel U, Szczepanski R, Moeller J, Deiss D. Parental preference of prandial insulin aspart compared with preprandial human insulin in a basal-bolus scheme with NPH insulin in a 12-wk crossover study of preschool children with type 1 diabetes. Pediatr Diabetes. 2007 Oct;8(5):278-85. doi: 10.1111/j.1399-5448.2007.00261.x.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes
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