Diabetes MellitusPhase 1NCT01937702
A Trial Investigating the Influence of Injection Speed and Volume on the Perception of Subcutaneous Injection Pain
A Phase 1 study testing 0.9% NaCl (sodium chloride) in people with Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
Trial summary
A trial, investigating the influence of injection speed and volume on the perception of subcutaneous injection pain. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- 0.9% NaCl (sodium chloride)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Sep 2014
- 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
- Subject has signed the informed consent form prior to screening
- Age 18-74 years at screening (both included)
Who cannot join
- Known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit
- Previous participation in this trial. Participation is defined as having received at least one injection
Trial locations and contacts
1 site in 1 country.
About this study
A trial, investigating the influence of injection speed and volume on the perception of subcutaneous injection pain.
- Conditions
- Diabetes Mellitus
- Being tested
- 0.9% NaCl (sodium chloride)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% NaCl (sodium chloride)Other
| Study group | Role | What they receive |
|---|---|---|
| Anti-diabetes medication | Experimental | Insulin Receives: Other: 0.9% NaCl (sodium chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
injection pain
Measured: within 24 hours after injection
Secondary outcomes (1)
variability of injection pain
Measured: within the first 24 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Forst, Prof, MD, Principal investigator, Profil Mainz GmbH & Co KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937702
- Sponsor's protocol ID
- PSIP
- Status last verified
- Dec 2014
- First submitted
- 27 Aug 2013
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Influence of Injection Speed and Volume on the Perception of Subcutaneous Injection Pain
- ClinicalTrials.gov ID
- NCT01937702
- Acronym / sponsor ID
- PSIP
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbHIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Sep 2013 (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.
A trial, investigating the influence of injection speed and volume on the perception of subcutaneous injection pain.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-diabetes medication | Experimental | Other: 0.9% NaCl (sodium chloride)Insulin |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has signed the informed consent form prior to screening
- Age 18-74 years at screening (both included)
Key exclusion criteria (2 listed)
- Known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit
- Previous participation in this trial. Participation is defined as having received at least one injection
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 |
|---|---|---|
| 0.9% NaCl (sodium chloride) | Other | Anti-diabetes medication |
Primary outcome
injection pain
Time frame: within 24 hours after injection
1 secondary outcome
variability of injection pain
Time frame: within the first 24 hours after 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 30 Dec 2014.
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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.
Thomas Forst, Prof, MD principal investigator
Profil Mainz GmbH & Co KG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.9% NaCl (sodium chloride) in people with Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 1 site 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 2 inclusion and 2 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 30 Dec 2014. 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 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 pain (time frame: within 24 hours 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 30 Dec 2014.