- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00569998
Comparison of Two Pen Systems in Patients With Diabetes Treated With Insulin
January 18, 2017 updated by: Novo Nordisk A/S
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
208
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wien, Austria, 1090
- Novo Nordisk INvestigational Site
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Wien, Austria, A 1090
- Novo Nordisk INvestigational Site
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Köln, Germany, 50858
- Novo Nordisk INvestigational Site
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Leverkusen, Germany, 51373
- Novo Nordisk INvestigational Site
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München, Germany, 81377
- Novo Nordisk INvestigational Site
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Speyer, Germany, 67346
- Novo Nordisk INvestigational Site
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St. Ingbert, Germany, 66386
- Novo Nordisk INvestigational Site
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Völklingen, Germany, 66333
- Novo Nordisk INvestigational Site
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Catania, Italy, 95122
- Novo Nordisk INvestigational Site
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Palermo, Italy, 90127
- Novo Nordisk INvestigational Site
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Parma, Italy, 43100
- Novo Nordisk INvestigational Site
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Roma, Italy, 00165
- Novo Nordisk INvestigational Site
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Torino, Italy, 10144
- Novo Nordisk INvestigational Site
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Almere, Netherlands, 1315 RA
- Novo Nordisk INvestigational Site
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Amsterdam, Netherlands, 1081 HV
- Novo Nordisk INvestigational Site
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Den Haag, Netherlands, 2512 VA
- Novo Nordisk INvestigational Site
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Heerlen, Netherlands, 6419 PC
- Novo Nordisk INvestigational Site
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Rotterdam, Netherlands, 3015 GD
- Novo Nordisk INvestigational Site
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Veldhoven, Netherlands, 5504 DB
- Novo Nordisk INvestigational Site
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Belfast, United Kingdom, BT37 9RH
- Novo Nordisk INvestigational Site
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Belfast, United Kingdom, BT12 6BE
- Novo Nordisk INvestigational Site
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Leeds, United Kingdom, LS9 7TF
- Novo Nordisk INvestigational Site
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Sidcup, United Kingdom, DA14 6LT
- Novo Nordisk INvestigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Evaluation of overall pen preference
Time Frame: after 12 weeks of treatment
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after 12 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
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Adverse events
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HbA1c
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Adverse device effects
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kolaczynski M, Chayer D. NovoPen® 4: perceived as superior in handling and acceptance versus HumaPen® Ergo and OptiPen® Pro in patients and healthcare professionals. Diabetes Technology & Therapeutics 2005; 7 (2): 390
- Goke B, Gamba S, Erdtsieck RJ, Gilbey S, Schober E, Lytzen L, Kolaczynski M. NovoPen 4 offers superior performance, handling and acceptance compared with NovoPen 3 in insulin-treated diabetes patients. Diabetes Technology and Therapeutics 2005; 7 (2): 379-380
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2003
Primary Completion (Actual)
February 1, 2004
Study Completion (Actual)
February 1, 2004
Study Registration Dates
First Submitted
December 4, 2007
First Submitted That Met QC Criteria
December 7, 2007
First Posted (Estimate)
December 10, 2007
Study Record Updates
Last Update Posted (Estimate)
January 19, 2017
Last Update Submitted That Met QC Criteria
January 18, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS236-1544
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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