DiabetesPhase 3NCT00872560
Comparison of 2 NovoFine® Needles on the Reflux of Insulin
A Phase 3 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 1 site in Italy.
Trial summary
This trial is conducted in Europe. This trial aims to ensure that there is no substantial clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and NovoFine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Delivery Systems
- What is being tested?
- NovoFine® needle 6 mm and NovoFine® needle 8 mm
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 1998to 27 Jul 1998
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children/adolescents with type 1 diabetes mellitus
- Usage of NovoPen® 1.5 for at least 3 months
- Duration of insulin treatment more than 1 year
- Normal weight according to Tanner scales
- The means of the last 2 HbA1c measurements taken within the last 6 months must be less than 10.5%
Who cannot join
- Pregnancy or desire to become pregnant
- Clinical relevant peripheral neuropathy as judged by the investigators
- Pronounced lipodystrophy in accordance with investigator's evaluation
- Use of drugs that can influence the trial
- Coagulation disorders (use of anti-coagulants)
- Serious, chronic diseases, making it highly unlikely that the subject can complete the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insulin Leakage and Pain Perception in IDDM Children or Adolescents, Where the Injections Are Performed With NovoFine™ 6 x 0.30 mm Needles and NovoFine® 8 x 0.30 mm Needles: An Open, Randomized, Two-period Cross-over, Multi-centre, Phase IIIb Trial at 4 Centres
This trial is conducted in Europe. This trial aims to ensure that there is no substantial clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and NovoFine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Delivery Systems
- Being tested
- NovoFine® needle 6 mm, NovoFine® needle 8 mm
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoFine® needle 6 mmDevice
Also called NEEDLEN
NovoFine® needle 8 mmDevice
Also called NEEDLEN
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighing of reflux of insulin
Measured: 6 seconds after injection
Secondary outcomes (3)
Pain perception
Measured: after 6 weeks of treatment
Number and severity of bleedings
Measured: after 6 weeks of treatment
Reactions at injection sites
Measured: after 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study start20 Jan 1998
- Primary completion27 Jul 1998
- Study completion27 Jul 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 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
- NCT00872560
- Sponsor's protocol ID
- NEEDLEN/DCD/4/I
- Status last verified
- Aug 2018
- First submitted
- 30 Mar 2009
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Leakage and Pain Perception in IDDM Children or Adolescents, Where the Injections Are Performed With NovoFine™ 6 x 0.30 mm Needles and NovoFine® 8 x 0.30 mm Needles: An Open, Randomized, Two-period Cross-over, Multi-centre, Phase IIIb Trial at 4 Centres
- ClinicalTrials.gov ID
- NCT00872560
- Acronym / sponsor ID
- NEEDLEN/DCD/4/I
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Delivery Systems
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 1998 (actual)
- Primary completion
- 27 Jul 1998 (actual)
- Study completion
- 27 Jul 1998 (actual)
- First posted
- 31 Mar 2009 (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. This trial aims to ensure that there is no substantial clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and NovoFine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children/adolescents with type 1 diabetes mellitus
- Usage of NovoPen® 1.5 for at least 3 months
- Duration of insulin treatment more than 1 year
- Normal weight according to Tanner scales
- The means of the last 2 HbA1c measurements taken within the last 6 months must be less than 10.5%
Key exclusion criteria (6 listed)
- Pregnancy or desire to become pregnant
- Clinical relevant peripheral neuropathy as judged by the investigators
- Pronounced lipodystrophy in accordance with investigator's evaluation
- Use of drugs that can influence the trial
- Coagulation disorders (use of anti-coagulants)
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 mmAlso: NEEDLEN | Device | – |
| NovoFine® needle 8 mmAlso: NEEDLEN | Device | – |
Primary outcome
Weighing of reflux of insulin
Time frame: 6 seconds after injection
3 secondary outcomes
Pain perception
Time frame: after 6 weeks of treatment
Number and severity of bleedings
Time frame: after 6 weeks of treatment
Reactions at injection sites
Time frame: after 6 weeks of treatment
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 7 Aug 2018.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 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 1 site in Italy.
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 5 inclusion and 6 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 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Weighing of reflux of insulin (time frame: 6 seconds after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2018.