Comparison of Two Pen Systems in Patients With Diabetes Treated With Insulin

Phase 3

Completed

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

• Registration Number: NCT00569998
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare two insulin delivery pens in the everyday life setting of patients with diabetes treated with insulin.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-07
• Study First Posted: 2007-12-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

• Type 1 or type 2 diabetes mellitus for at least 12 months
• Adults at least 18 years
• Children/adolescents between 9-18 years
• HbA1c lesser than or equal to 11.0%

Exclusion Criteria

• Known or suspected alcohol or drug abuse
• Patients who are not able to read the user manual (may wear glasses if needed)
• Hypoglycaemic unawareness as judged by the investigator
• Visual and/or dexterity impairments as judged by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Evaluation of overall pen preference	after 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Adverse device effects
Adverse events
HbA1c

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Sidcup, United Kingdom