Back to resultsComparison of 2 NovoFine® Needles on the Reflux of Insulin
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1, Delivery Systems
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
NovoFine® needle 6 mm
NovoFine® needle 8 mm
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Children/adolescents with type 1 diabetes mellitus
- Usage of NovoPen® 1.5 for at least 3 months
- Duration of insulin treatment more than 1 year
- Normal weight according to Tanner scales
- The means of the last 2 HbA1c measurements taken within the last 6 months must be less than 10.5%
Exclusion Criteria:
- Pregnancy or desire to become pregnant
- Clinical relevant peripheral neuropathy as judged by the investigators
- Pronounced lipodystrophy in accordance with investigator's evaluation
- Use of drugs that can influence the trial
- Coagulation disorders (use of anti-coagulants)
- Serious, chronic diseases, making it highly unlikely that the subject can complete the trial
Sites / Locations
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Weighing of reflux of insulin
Secondary Outcome Measures
Pain perception
Number and severity of bleedings
Reactions at injection sites
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00872560
Brief Title
Comparison of 2 NovoFine® Needles on the Reflux of Insulin
Official Title
Insulin Leakage and Pain Perception in IDDM Children or Adolescents, Where the Injections Are Performed With NovoFine™ 6 x 0.30 mm Needles and NovoFine® 8 x 0.30 mm Needles: An Open, Randomized, Two-period Cross-over, Multi-centre, Phase IIIb Trial at 4 Centres
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 20, 1998 (Actual)
Primary Completion Date
July 27, 1998 (Actual)
Study Completion Date
July 27, 1998 (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. This trial aims to ensure that there is no substantial clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and NovoFine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1, Delivery Systems
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
NovoFine® needle 6 mm
Other Intervention Name(s)
NEEDLEN
Intervention Type
Device
Intervention Name(s)
NovoFine® needle 8 mm
Other Intervention Name(s)
NEEDLEN
Primary Outcome Measure Information:
Title
Weighing of reflux of insulin
Time Frame
6 seconds after injection
Secondary Outcome Measure Information:
Title
Pain perception
Time Frame
after 6 weeks of treatment
Title
Number and severity of bleedings
Time Frame
after 6 weeks of treatment
Title
Reactions at injection sites
Time Frame
after 6 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children/adolescents with type 1 diabetes mellitus
Usage of NovoPen® 1.5 for at least 3 months
Duration of insulin treatment more than 1 year
Normal weight according to Tanner scales
The means of the last 2 HbA1c measurements taken within the last 6 months must be less than 10.5%
Exclusion Criteria:
Pregnancy or desire to become pregnant
Clinical relevant peripheral neuropathy as judged by the investigators
Pronounced lipodystrophy in accordance with investigator's evaluation
Use of drugs that can influence the trial
Coagulation disorders (use of anti-coagulants)
Serious, chronic diseases, making it highly unlikely that the subject can complete the 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
Chieti
ZIP/Postal Code
66100
Country
Italy
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Comparison of 2 NovoFine® Needles on the Reflux of Insulin
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