MedPath

Transdermally Delivered Human Insulin Product

Completed
Conditions
Hypoinsulinemia
Registration Number
NCT03544996
Lead Sponsor
Transdermal Delivery Solutions Corp
Brief Summary

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
1
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Insulin response8-24 hours

Measurement of down modulation of serum glucose as measured by a standard blood glucose meter not otherwise attributable to injected insulin

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Langford Research Institute

🇺🇸

Palm Beach Gardens, Florida, United States

Langford Research Institute
🇺🇸Palm Beach Gardens, Florida, United States

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