DiabetesPhase 3NCT00569998
Comparison of Two Pen Systems in Patients With Diabetes Treated With Insulin
A Phase 3 study testing NovoPen™ 4 and NovoPen® 3 in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 23 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- NovoPen™ 4 and NovoPen® 3
- Type of treatment
- Medical device
- How many people
- 208 participants
- Where
- 23 sitesin 5 countries
- Study dates
- Aug 2003to Feb 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
23 sites in 5 countries.
23 sites in 5 countries
Germany6 sites
Novo Nordisk Investigational Site
Cologne, 50858
Novo Nordisk Investigational Site
Leverkusen, 51373
Novo Nordisk Investigational Site
München, 81377
Novo Nordisk Investigational Site
Saint Ingbert, 66386
Novo Nordisk Investigational Site
Speyer, 67346
Novo Nordisk Investigational Site
Völklingen, 66333
Netherlands6 sites
Novo Nordisk Investigational Site
Almere Stad, 1315 RA
Novo Nordisk Investigational Site
Amsterdam, 1081 HV
Novo Nordisk Investigational Site
Heerlen, 6419 PC
Novo Nordisk Investigational Site
Rotterdam, 3015 GD
Novo Nordisk Investigational Site
The Hague, 2512 VA
Novo Nordisk Investigational Site
Veldhoven, 5504 DB
Italy5 sites
Novo Nordisk Investigational Site
Catania, 95122
Novo Nordisk Investigational Site
Palermo, 90127
Novo Nordisk Investigational Site
Parma, 43100
Novo Nordisk Investigational Site
Roma, 00165
Novo Nordisk Investigational Site
Torino, 10144
United Kingdom4 sites
Novo Nordisk Investigational Site
Belfast, BT12 6BE
Novo Nordisk Investigational Site
Belfast, BT37 9RH
Novo Nordisk Investigational Site
Leeds, LS9 7TF
Novo Nordisk Investigational Site
Sidcup, DA14 6LT
Austria2 sites
Novo Nordisk Investigational Site
Vienna, 1090
Novo Nordisk Investigational Site
Vienna, A 1090
About this study
Official title: 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.
- Being tested
- NovoPen™ 4, NovoPen® 3
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoPen™ 4Device
NovoPen® 3Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of overall pen preference
Measured: after 12 weeks of treatment
Secondary outcomes (3)
HbA1c
Adverse device effects
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2007 (estimated)
- Study startAug 2003
- Primary completionFeb 2004
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569998
- Sponsor's protocol ID
- MS236-1544
- Status last verified
- Jan 2017
- First submitted
- 4 Dec 2007
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00569998
- Acronym / sponsor ID
- MS236-1544
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 10 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NovoPen™ 4 | Device | – |
| NovoPen® 3 | Device | – |
Primary outcome
Evaluation of overall pen preference
Time frame: after 12 weeks of treatment
3 secondary outcomes
HbA1c
Adverse device effects
Adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Results publicationKolaczynski 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
- Results publicationGoke 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
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
23 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NovoPen™ 4 and NovoPen® 3 in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 23 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany, Netherlands, Italy, United Kingdom, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of overall pen preference (time frame: after 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00569998, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.