Transdermally Delivered Human Insulin Product

Transdermal Delivery Solutions Corp1 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hypoinsulinemia

Interventions

TD InsulinCOMBINATION_PRODUCT

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

Eligibility

Sex: MALEMin age: 60 YearsMax age: 61 Years

Medical Language ↔ Plain English

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

Locations (1)

Langford Research Institute

Palm Beach Gardens, Florida, United States

Outcomes

Primary Outcomes

Insulin response

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

Time frame: 8-24 hours

Data from ClinicalTrials.gov

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