HypoinsulinemiaNCT03544996
Transdermally Delivered Human Insulin Product
An observational study of Hypoinsulinemia, run by Transdermal Delivery Solutions Corp at 1 site in United States.
Trial summary
An Early Feasibility Study of a device formulation to deliver human insulin across intact skin Read more about this study
- Who is it for?
- Ages 60 to 61 years, men only
- Conditions the study is for
- Hypoinsulinemia
- What is being tested?
- TD Insulin
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2017to 4 Feb 2018
- Phase
- Observational
- 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 60 to 61 years
- Men only
- No healthy volunteers
- Adult
Study population: Single patient, brittle T1D patient
Who may be able to join
- Brittle T1D patient with poor insulin sensitivity requiring more than 3,000 IUs on insulin a day
Who cannot join
- High insulin sensitivity
- well managed serum glucose
Trial locations and contacts
1 site in 1 country.
United States1 site
Langford Research Institute
Palm Beach Gardens, Florida, 33410
About this study
Official title: A Comparison of Injected Insulin Replacement Therapy With A Novel Transdermally Delivered Human Insulin Product
An Early Feasibility Study of a device formulation to deliver human insulin across intact skin
Read the detailed description
An attempt was made to formulate an insulin product that would complex human insulin in a stable anhydrous solution and when applied to the skin enable the uptake and release of insulin in a brittle T1D patient.
A series of formulations were produced at varing dose strengths and in conjunction with injected insulin products, applied and serum glucose measured to ascertain response and optimize a fomrula to be submitted for IND approval.
- Conditions
- Hypoinsulinemia
- Being tested
- TD Insulin
- Keywords
- Insulin, needle-less, transdermal
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD InsulinCombination product
Human Insulin USP formulated in a solution capable of transdermal delivery.
| Study group | Role | What they receive |
|---|---|---|
| TD Insulin Pilot | Test of novel transdermal insulin (TD Insulin) formulations Receives: Combination Product: TD Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin response
Measurement of down modulation of serum glucose as measured by a standard blood glucose meter not otherwise attributable to injected insulin
Measured: 8-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start9 Sep 2017
- Primary completion4 Feb 2018
- Study completion4 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoinsulinemiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transdermal Delivery Solutions Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William D Kirsh, D.O., Principal investigator, Sentry Data Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544996
- Sponsor's protocol ID
- TDS INS-001
- Status last verified
- May 2018
- First submitted
- 22 May 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Injected Insulin Replacement Therapy With A Novel Transdermally Delivered Human Insulin Product
- ClinicalTrials.gov ID
- NCT03544996
- Acronym / sponsor ID
- TDS INS-001
- Conditions
- Hypoinsulinemia
- Keywords
- Insulin, needle-less, transdermal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Transdermal Delivery Solutions CorpIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2017 (actual)
- Primary completion
- 4 Feb 2018 (actual)
- Study completion
- 4 Feb 2018 (actual)
- First posted
- 4 Jun 2018 (actual)
- 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.
An Early Feasibility Study of a device formulation to deliver human insulin across intact skin
Detailed description
An attempt was made to formulate an insulin product that would complex human insulin in a stable anhydrous solution and when applied to the skin enable the uptake and release of insulin in a brittle T1D patient.
A series of formulations were produced at varing dose strengths and in conjunction with injected insulin products, applied and serum glucose measured to ascertain response and optimize a fomrula to be submitted for IND approval.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TD Insulin Pilot | – | Combination Product: TD InsulinTest of novel transdermal insulin (TD Insulin) formulations |
Who may qualify
- Ages
- 60 to 61 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Single patient, brittle T1D patient
Key inclusion criteria (1 listed)
- Brittle T1D patient with poor insulin sensitivity requiring more than 3,000 IUs on insulin a day
Key exclusion criteria (2 listed)
- High insulin sensitivity
- well managed serum glucose
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 |
|---|---|---|
| TD InsulinHuman Insulin USP formulated in a solution capable of transdermal delivery. | Combination product | TD Insulin Pilot |
Primary outcome
Insulin response
Time frame: 8-24 hours
Measurement of down modulation of serum glucose as measured by a standard blood glucose meter not otherwise attributable to injected insulin
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 6 Jun 2018.
- Individual participant dataSharing planned: Undecided
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.
William D Kirsh, D.O. principal investigator
Sentry Data Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoinsulinemia, run by Transdermal Delivery Solutions Corp at 1 site in United States.
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 1 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 6 Jun 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 United States. 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.
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?
Insulin response (time frame: 8-24 hours). 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 6 Jun 2018.