Evaluating the Use of Two Different Needles in Subjects With Diabetes

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems; Diabetes

• Registration Number: NCT00569426
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-06
• Study First Posted: 2007-12-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Overall needle preference	after 2-3 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Handling and acceptance of needles
Injection pressure
Pain perception

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Sheffield, United Kingdom