Trials / Completed
CompletedNCT03544996
Transdermally Delivered Human Insulin Product
A Comparison of Injected Insulin Replacement Therapy With A Novel Transdermally Delivered Human Insulin Product
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1 (actual)
- Sponsor
- Transdermal Delivery Solutions Corp · Industry
- Sex
- Male
- Age
- 60 Years – 61 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | TD Insulin | Human Insulin USP formulated in a solution capable of transdermal delivery. |
Timeline
- Start date
- 2017-09-09
- Primary completion
- 2018-02-04
- Completion
- 2018-02-04
- First posted
- 2018-06-04
- Last updated
- 2018-06-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03544996. Inclusion in this directory is not an endorsement.