Transdermally Delivered Human Insulin Product
Completed
- Conditions
- Hypoinsulinemia
- Interventions
- Combination Product: TD Insulin
- 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
- Arm && Interventions
Group Intervention Description TD Insulin Pilot TD Insulin Test of novel transdermal insulin (TD Insulin) formulations
- Primary Outcome Measures
Name Time Method Insulin response 8-24 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
Name Time Method
Trial Locations
- Locations (1)
Langford Research Institute
🇺🇸Palm Beach Gardens, Florida, United States