Evaluating the Use of Two Different Needles in Subjects With Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00569426
First received: December 4, 2007
Last updated: March 26, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Injection pressure [ Designated as safety issue: No ]
  • Pain perception [ Designated as safety issue: No ]
  • Handling and acceptance of needles [ Designated as safety issue: No ]

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 and older
Genders Eligible for Study:   Both
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
Livingstone, United Kingdom, EH54 6PP
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Mark Fitch, BSc Novo Nordisk Pharma. Ltd.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00569426     History of Changes
Other Study ID Numbers: NEEDLEN-1637
Study First Received: December 4, 2007
Last Updated: March 26, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory

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

ClinicalTrials.gov processed this record on July 31, 2014