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Transdermally Delivered Human Insulin Product

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03544996
Recruitment Status : Completed
First Posted : June 4, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Transdermal Delivery Solutions Corp

Study Description
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Brief Summary:
An Early Feasibility Study of a device formulation to deliver human insulin across intact skin

Condition or disease Intervention/treatment
Hypoinsulinemia Combination Product: TD Insulin

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
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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Comparison of Injected Insulin Replacement Therapy With A Novel Transdermally Delivered Human Insulin Product
Actual Study Start Date : September 9, 2017
Actual Primary Completion Date : February 4, 2018
Actual Study Completion Date : February 4, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
TD Insulin Pilot
Test of novel transdermal insulin (TD Insulin) formulations
 Combination Product: TD Insulin
Human Insulin USP formulated in a solution capable of transdermal delivery.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 61 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Single patient, brittle T1D patient
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03544996


Locations
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United States, Florida
Langford Research Institute
Palm Beach Gardens, Florida, United States, 33410
Sponsors and Collaborators
Transdermal Delivery Solutions Corp
Investigators
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Principal Investigator: William D Kirsh, D.O. Sentry Data Systems
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Transdermal Delivery Solutions Corp
ClinicalTrials.gov Identifier: NCT03544996    
Other Study ID Numbers: TDS INS-001
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Transdermal Delivery Solutions Corp:
Insulin, needle-less, transdermal
Additional relevant MeSH terms:
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Insulin
Hypoglycemic Agents
Physiological Effects of Drugs