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

An Open-label, Multi-centre, Multi-national, Comparative, Randomised, Cross-over Trial Evaluating Preference as Well as Performance, Acceptance, Handling and Safety of NovoPen™ 4 (MS236) Versus NovoPen 3® in Insulin Treated Diabetic Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00569998

Enrollment

208

Registered

2007-12-10

Start date

2003-08-31

Completion date

2004-02-29

Last updated

2017-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery Systems, Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

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.

Interventions

DEVICENovoPen™ 4

DEVICENovoPen® 3

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

9 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Evaluation of overall pen preference	after 12 weeks of treatment

Secondary

Measure	Time frame
HbA1c	—
Adverse device effects	—
Adverse events	—

Countries

Austria, Germany, Italy, Netherlands, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026