DiabetesPhase 4NCT00569426
Evaluating the Use of Two Different Needles in Subjects With Diabetes
A Phase 4 study testing NovoFine® needle 6 mm and NovoFine® needle 8 mm in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 10 sites in United Kingdom.
Trial summary
This trial is conducted in Europe. The aim of this trial is to compare two needle types when used with a disposable insulin injection pen in the everyday life setting of an insulin treated patient with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- NovoFine® needle 6 mm and NovoFine® needle 8 mm
- Type of treatment
- Medical device
- How many people
- 119 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- Apr 2005to Jun 2005
- Phase
- Phase 4
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent obtained before any trial-related activities
- Diagnosed type 1 or type 2 diabetes
- Treated with insulin
Who cannot join
- Previous participation in this trial
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
- Any disease or condition which the investigator feels would interfere with the trial
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites
Novo Nordisk Investigational Site
Cambridge, CB2 2QQ
Novo Nordisk Investigational Site
Cardiff, CF14 4XW
Novo Nordisk Investigational Site
Church Village, CF38 1AB
Novo Nordisk Investigational Site
Dundee, DD1 9SY
Novo Nordisk Investigational Site
Haywards Heath, RH16 4EX
Novo Nordisk Investigational Site
Liverpool, L9 7AL
Novo Nordisk Investigational Site
Livingstone, EH54 6PP
Novo Nordisk Investigational Site
Penarth, CF64 2XX
Novo Nordisk Investigational Site
Plymouth, PL8 8DQ
Novo Nordisk Investigational Site
Sheffield, S5 7AU
About this study
Official title: An Open-label, Randomised, Multi-centre Cross-over Trial in Diabetes Patients Evaluating Preference, Injection Pressure, Pain Perception and Handling When Injections Are Performed With Two Different Needles i.e. NovoFine® 32 Gauge Tip x 6mm and NovoFine® 30 Gauge x 8mm Using a FlexPen® Disposable Insulin Injection Pen
This trial is conducted in Europe. The aim of this trial is to compare two needle types when used with a disposable insulin injection pen in the everyday life setting of an insulin treated patient with diabetes.
- Being tested
- NovoFine® needle 6 mm, NovoFine® needle 8 mm
- 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.
NovoFine® needle 6 mmDevice
NovoFine® needle 8 mmDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall needle preference
Measured: after 2-3 weeks of treatment
Secondary outcomes (3)
Injection pressure
Pain perception
Handling and acceptance of needles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startApr 2005
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 119 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
- NCT00569426
- Sponsor's protocol ID
- NEEDLEN-1637
- Status last verified
- Jan 2017
- First submitted
- 4 Dec 2007
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
McKay M, Compion G, Lytzen L. Pain Perception, Patient Preference, Injection Pressure and Handling with NovoFine® 32G x 6mm Versus 30G x 8mm Needle. ADA 2006; : 1968-PO
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, Randomised, Multi-centre Cross-over Trial in Diabetes Patients Evaluating Preference, Injection Pressure, Pain Perception and Handling When Injections Are Performed With Two Different Needles i.e. NovoFine® 32 Gauge Tip x 6mm and NovoFine® 30 Gauge x 8mm Using a FlexPen® Disposable Insulin Injection Pen
- ClinicalTrials.gov ID
- NCT00569426
- Acronym / sponsor ID
- NEEDLEN-1637
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 7 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 needle types when used with a disposable insulin injection pen in the everyday life setting of an insulin treated patient with diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed and dated informed consent obtained before any trial-related activities
- Diagnosed type 1 or type 2 diabetes
- Treated with insulin
Key exclusion criteria (3 listed)
- Previous participation in this trial
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
- Any disease or condition which the investigator feels would interfere with the trial
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 |
|---|---|---|
| NovoFine® needle 6 mm | Device | – |
| NovoFine® needle 8 mm | Device | – |
Primary outcome
Overall needle preference
Time frame: after 2-3 weeks of treatment
3 secondary outcomes
Injection pressure
Pain perception
Handling and acceptance of needles
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 publicationMcKay M, Compion G, Lytzen L. Pain Perception, Patient Preference, Injection Pressure and Handling with NovoFine® 32G x 6mm Versus 30G x 8mm Needle. ADA 2006; : 1968-PO
- 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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NovoFine® needle 6 mm and NovoFine® needle 8 mm in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 10 sites in United Kingdom.
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 3 inclusion and 3 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 10 sites in United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Overall needle preference (time frame: after 2-3 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 NCT00569426, which also lists 1 linked publication.
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.