DiabetesPhase 1NCT02627287
A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen®
A Phase 1 study testing FlexPen® and DV3316 pen-injector in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 2 sites in Germany.
Trial summary
This trial is conducted in Europe. The aim of this trial is to compare Injections with the Medical Device DV3316 Pen-injector versus FlexPen®. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- FlexPen® and DV3316 pen-injector
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Dec 2015to 25 Feb 2016
- Phase
- Phase 1
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18-74 years (both included) at the time of signing informed consent
- T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus) (as diagnosed clinically) at least 12 months prior to screening
- Daily self-injection(s) with anti-diabetic drug (insulin or Glucagon-Like Peptide-1 (GLP- 1) analogues) in pen-injector or vial/syringe for at least 12 months
- Caucasians
- Body Mass Index (BMI) at least 18.5 kg/m^2
Who cannot join
- Known or suspected hypersensitivity to test placebo solution incl. m-cresol and phenol or related products (placebo)
- Female who is pregnant,, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
- Known urticaria factitive or abnormal reactions to mechanical trauma
- Haemophilia and any diseases affecting blood coagulation
- Anti-coagulant or inhibitors of platelet aggregation treatment on the day of the visit
- Intake of any pain-relieving or analgesic drugs on the day of the site visit
- Skin diseases and infections of the skin in the injection site areas (abdomen and thighs)
- Lipodystrophia in the injection site areas (abdomen and thighs)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Novo Nordisk Investigational Site
Mainz, 55116
Novo Nordisk Investigational Site
Neuss, 41460
About this study
Official title: A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen
This trial is conducted in Europe. The aim of this trial is to compare Injections with the Medical Device DV3316 Pen-injector versus FlexPen®.
- Being tested
- FlexPen®, DV3316 pen-injector, placebo
- 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.
FlexPen®Device
For subcutaneously (s.c. under the skin) injection.
DV3316 pen-injectorDevice
For subcutaneously (s.c. under the skin) injection.
placeboDrug
For subcutaneously (s.c. under the skin) injection
| Study group | Role | What they receive |
|---|---|---|
| DV3316 pen-injector | Experimental | Not described Receives: Device: DV3316 pen-injector; Drug: placebo |
| FlexPen® | Active comparator | Not described Receives: Device: FlexPen®; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injection success (full dose delivered s.c.) (yes/no)
Measured: By assessment that the dose counter has returned to "0" (EoD confirmation) for the DV3316 pen-injector and for FlexPen® at least 6 seconds after the dose counter has returned to "0"
Secondary outcomes (8)
Subjects' confidence in injection completion (delivery of correct, full dose)
Measured: Injection completed within 2 minutes after needle insertion
Amount of liquid on the skin (placebo solution or tissue fluid)
Measured: Injection completed within 2 minutes after needle insertion
Subjects' reaction time
Measured: Injection completed within 2 minutes after needle insertion
Subjects evaluation of pen-injector experience
Measured: Injections completed within 2 minutes of needle insertion
Number of technical complaints
Measured: Day 1
Number of adverse device effects
Measured: Day 1
Grading of bleeding, redness, bruising and swelling at the site of injection
Measured: Within 10 minutes after completion of injection
Grading of bleeding, redness, bruising and swelling at the site of injection
Measured: 1 hour after completion of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start1 Dec 2015
- Primary completion25 Feb 2016
- Study completion25 Feb 2016
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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 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
- NCT02627287
- Sponsor's protocol ID
- INS-4208
- Other IDs
- 2014-004802-13, U1111-1163-5039, 2014
- Status last verified
- Feb 2018
- First submitted
- 27 Nov 2015
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Tang H, Li G, Zhao Y, Wang F, Gower EW, Shi L, Wang T. Comparisons of diabetic retinopathy events associated with glucose-lowering drugs in patients with type 2 diabetes mellitus: A network meta-analysis. Diabetes Obes Metab. 2018 May;20(5):1262-1279. doi: 10.1111/dom.13232. Epub 2018 Feb 23.
PubMed 29369494Zijlstra E, Coester HV, Heise T, Plum-Morschel L, Rasmussen O, Rikte T, Pedersen LK, Qvist M, Sparre T. Injecting without pressing a button: An exploratory study of a shield-triggered injection mechanism. Diabetes Obes Metab. 2018 May;20(5):1140-1147. doi: 10.1111/dom.13203. Epub 2018 Jan 25.
PubMed 29369493
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen
- ClinicalTrials.gov ID
- NCT02627287
- Acronym / sponsor ID
- INS-4208
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 25 Feb 2016 (actual)
- Study completion
- 25 Feb 2016 (actual)
- First posted
- 10 Dec 2015 (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 Injections with the Medical Device DV3316 Pen-injector versus FlexPen®.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DV3316 pen-injector | Experimental | Device: DV3316 pen-injector, Drug: placebo |
| FlexPen® | Active comparator | Device: FlexPen®, Drug: placebo |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged 18-74 years (both included) at the time of signing informed consent
- T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus) (as diagnosed clinically) at least 12 months prior to screening
- Daily self-injection(s) with anti-diabetic drug (insulin or Glucagon-Like Peptide-1 (GLP- 1) analogues) in pen-injector or vial/syringe for at least 12 months
- Caucasians
- Body Mass Index (BMI) at least 18.5 kg/m^2
Key exclusion criteria (8 listed)
- Known or suspected hypersensitivity to test placebo solution incl. m-cresol and phenol or related products (placebo)
- Female who is pregnant,, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
- Known urticaria factitive or abnormal reactions to mechanical trauma
- Haemophilia and any diseases affecting blood coagulation
- Anti-coagulant or inhibitors of platelet aggregation treatment on the day of the visit
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 |
|---|---|---|
| FlexPen®For subcutaneously (s.c. under the skin) injection. | Device | FlexPen® |
| DV3316 pen-injectorFor subcutaneously (s.c. under the skin) injection. | Device | DV3316 pen-injector |
| placeboFor subcutaneously (s.c. under the skin) injection | Drug | DV3316 pen-injector, FlexPen® |
Primary outcome
Injection success (full dose delivered s.c.) (yes/no)
Time frame: By assessment that the dose counter has returned to "0" (EoD confirmation) for the DV3316 pen-injector and for FlexPen® at least 6 seconds after the dose counter has returned to "0"
8 secondary outcomes
Subjects' confidence in injection completion (delivery of correct, full dose)
Time frame: Injection completed within 2 minutes after needle insertion
Amount of liquid on the skin (placebo solution or tissue fluid)
Time frame: Injection completed within 2 minutes after needle insertion
Subjects' reaction time
Time frame: Injection completed within 2 minutes after needle insertion
Subjects evaluation of pen-injector experience
Time frame: Injections completed within 2 minutes of needle insertion
Number of technical complaints
Time frame: Day 1
Number of adverse device effects
Time frame: Day 1
Grading of bleeding, redness, bruising and swelling at the site of injection
Time frame: Within 10 minutes after completion of injection
Grading of bleeding, redness, bruising and swelling at the site of injection
Time frame: 1 hour after completion of injection
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 Feb 2018.
- Results publication: PubMed 29369494Tang H, Li G, Zhao Y, Wang F, Gower EW, Shi L, Wang T. Comparisons of diabetic retinopathy events associated with glucose-lowering drugs in patients with type 2 diabetes mellitus: A network meta-analysis. Diabetes Obes Metab. 2018 May;20(5):1262-1279. doi: 10.1111/dom.13232. Epub 2018 Feb 23.
- Results publication: PubMed 29369493Zijlstra E, Coester HV, Heise T, Plum-Morschel L, Rasmussen O, Rikte T, Pedersen LK, Qvist M, Sparre T. Injecting without pressing a button: An exploratory study of a shield-triggered injection mechanism. Diabetes Obes Metab. 2018 May;20(5):1140-1147. doi: 10.1111/dom.13203. Epub 2018 Jan 25.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FlexPen® and DV3316 pen-injector in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 2 sites in Germany.
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 8 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 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Injection success (full dose delivered s.c.) (yes/no) (time frame: By assessment that the dose counter has returned to "0" (EoD confirmation) for the DV3316 pen-injector and for FlexPen® at least 6 seconds after the dose counter has returned to "0"). 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 NCT02627287, 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 7 Feb 2018.