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Evaluating the Use of Two Different Needles in Subjects With Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
NovoFine® needle 6 mm
NovoFine® needle 8 mm
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

Overall needle preference

Secondary Outcome Measures

Injection pressure
Pain perception
Handling and acceptance of needles

Full Information

First Posted
December 4, 2007
Last Updated
January 18, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00569426
Brief Title
Evaluating the Use of Two Different Needles in Subjects With Diabetes
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (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 compare two needle types when used with a disposable insulin injection pen in the everyday life setting of an insulin treated patient with 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, Diabetes Mellitus, Type 2, Delivery Systems

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
NovoFine® needle 6 mm
Intervention Type
Device
Intervention Name(s)
NovoFine® needle 8 mm
Primary Outcome Measure Information:
Title
Overall needle preference
Time Frame
after 2-3 weeks of treatment
Secondary Outcome Measure Information:
Title
Injection pressure
Title
Pain perception
Title
Handling and acceptance of needles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Church Village
ZIP/Postal Code
CF38 1AB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Haywards Heath
ZIP/Postal Code
RH16 4EX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Livingstone
ZIP/Postal Code
EH54 6PP
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Penarth
ZIP/Postal Code
CF64 2XX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Plymouth
ZIP/Postal Code
PL8 8DQ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
Citation
McKay M, Compion G, Lytzen L. Pain Perception, Patient Preference, Injection Pressure and Handling with NovoFine® 32G x 6mm Versus 30G x 8mm Needle. ADA 2006; : 1968-PO
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Evaluating the Use of Two Different Needles in Subjects With Diabetes

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