NCT00569998|CompletedPhase 3

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

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

MS236-1544

Study Type

interventional

Target

208

Locations

5 countries

Sites

Timeline

RegisteredDec 2007

StartedAug 2003

CompletionFeb 2004

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

208

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Aug 2003

Shorter than P25 for phase_3 diabetes

Geographic Reach

5 countries

23 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

Study Start

First participant enrolled

August 1, 2003

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed

3.8 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed

6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2007

Completed

Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

December 4, 2007

Last Update Submit

January 18, 2017

Conditions

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

Outcome Measures

Primary Outcomes (1)

Evaluation of overall pen preference
after 12 weeks of treatment

Secondary Outcomes (3)

HbA1c
Adverse device effects
Adverse events

Interventions

NovoPen™ 4DEVICE

NovoPen® 3DEVICE

Eligibility Criteria

Age9 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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%

You may not qualify if:

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

Contact the study team to confirm eligibility.