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Evaluating the Use of Two Different Needles in Subjects With Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00569426
First received: December 4, 2007
Last updated: January 18, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Delivery Systems Device: NovoFine® needle 6 mm Device: NovoFine® needle 8 mm Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Overall needle preference [ Time Frame: after 2-3 weeks of treatment ]

Secondary Outcome Measures:
  • Injection pressure
  • Pain perception
  • Handling and acceptance of needles

Enrollment: 119
Study Start Date: April 2005
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569426

Locations
United Kingdom
Novo Nordisk Investigational Site
Cambridge, United Kingdom, CB2 2QQ
Novo Nordisk Investigational Site
Cardiff, United Kingdom, CF14 4XW
Novo Nordisk Investigational Site
Church Village, United Kingdom, CF38 1AB
Novo Nordisk Investigational Site
Dundee, United Kingdom, DD1 9SY
Novo Nordisk Investigational Site
Haywards Heath, United Kingdom, RH16 4EX
Novo Nordisk Investigational Site
Liverpool, United Kingdom, L9 7AL
Novo Nordisk Investigational Site
Livingstone, United Kingdom, EH54 6PP
Novo Nordisk Investigational Site
Penarth, United Kingdom, CF64 2XX
Novo Nordisk Investigational Site
Plymouth, United Kingdom, PL8 8DQ
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
  More Information

Additional Information:
Publications:
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

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00569426     History of Changes
Other Study ID Numbers: NEEDLEN-1637
Study First Received: December 4, 2007
Last Updated: January 18, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 21, 2017