Transdermally Delivered Human Insulin Product

NCT ID: NCT03544996

Last Updated: 2018-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-09

Study Completion Date

2018-02-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

An Early Feasibility Study of a device formulation to deliver human insulin across intact skin

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoinsulinemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TD Insulin Pilot

Test of novel transdermal insulin (TD Insulin) formulations

TD Insulin

Intervention Type COMBINATION_PRODUCT

Human Insulin USP formulated in a solution capable of transdermal delivery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TD Insulin

Human Insulin USP formulated in a solution capable of transdermal delivery.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Brittle T1D patient with poor insulin sensitivity requiring more than 3,000 IUs on insulin a day

Exclusion Criteria

* High insulin sensitivity
* well managed serum glucose
Minimum Eligible Age

60 Years

Maximum Eligible Age

61 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Transdermal Delivery Solutions Corp

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

William D Kirsh, D.O.

Role: PRINCIPAL_INVESTIGATOR

Sentry Data Systems

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Langford Research Institute

Palm Beach Gardens, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TDS INS-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.