Evaluating the Use of Two Different Needles in Subjects With Diabetes
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT00569426
Collaborator
(none)
119
10
2
11.9
5.9
Study Details
Study Description
Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare two needle types when used with a disposable insulin injection pen in the everyday life setting of an insulin treated patient with diabetes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
119 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Randomised, Multi-centre Cross-over Trial in Diabetes Patients Evaluating Preference, Injection Pressure, Pain Perception and Handling When Injections Are Performed With Two Different Needles i.e. NovoFine® 32 Gauge Tip x 6mm and NovoFine® 30 Gauge x 8mm Using a FlexPen® Disposable Insulin Injection Pen
Study Start Date
:
Apr 1, 2005
Actual Primary Completion Date
:
Jun 1, 2005
Actual Study Completion Date
:
Jun 1, 2005
Outcome Measures
Primary Outcome Measures
- Overall needle preference [after 2-3 weeks of treatment]
Secondary Outcome Measures
- Injection pressure []
- Pain perception []
- Handling and acceptance of needles []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Signed and dated informed consent obtained before any trial-related activities
-
Diagnosed type 1 or type 2 diabetes
-
Treated with insulin
Exclusion Criteria:
-
Previous participation in this trial
-
Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
-
Any disease or condition which the investigator feels would interfere with the trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Cambridge | United Kingdom | CB2 2QQ | |
| 2 | Novo Nordisk Investigational Site | Cardiff | United Kingdom | CF14 4XW | |
| 3 | Novo Nordisk Investigational Site | Church Village | United Kingdom | CF38 1AB | |
| 4 | Novo Nordisk Investigational Site | Dundee | United Kingdom | DD1 9SY | |
| 5 | Novo Nordisk Investigational Site | Haywards Heath | United Kingdom | RH16 4EX | |
| 6 | Novo Nordisk Investigational Site | Liverpool | United Kingdom | L9 7AL | |
| 7 | Novo Nordisk Investigational Site | Livingstone | United Kingdom | EH54 6PP | |
| 8 | Novo Nordisk Investigational Site | Penarth | United Kingdom | CF64 2XX | |
| 9 | Novo Nordisk Investigational Site | Plymouth | United Kingdom | PL8 8DQ | |
| 10 | Novo Nordisk Investigational Site | Sheffield | United Kingdom | S5 7AU |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00569426
Other Study ID Numbers:
- NEEDLEN-1637
First Posted:
Dec 7, 2007
Last Update Posted:
Jan 19, 2017
Last Verified:
Jan 1, 2017
Additional relevant MeSH terms: