Transdermally Delivered Human Insulin Product

Transdermal Delivery Solutions

Status: Completed

Conditions: Hypoinsulinemia

Treatments: Combination Product: TD Insulin

Study type: Observational

Funder types: Industry

Identifiers

NCT03544996

TDS INS-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 1 patient

Sex: Male

Ages: 60 to 61 years old

Volunteers: No Healthy Volunteers

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

Trial design

1 participants in 1 patient group

TD Insulin Pilot

Description:

Test of novel transdermal insulin (TD Insulin) formulations

Treatment:

Combination Product: TD Insulin