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Clinical Trial Summary

Bio-fermentation produced Human insulin is available without prescription in the U.S. This study is a physician-initated trial of a formula enabling transdermal delivery of human insulin.

Clinical Trial Description

The primary objective of the study is to determine the amount of lowering serum glucose as a function of dose of a topically applied formulation of Human Insulin administered by syringe measurement to adult Healthy Volunteer subjects as compared to no treatment. A 5-day period of daily blood sugar monitoring by means of wearable Continuous Glucose Monitor and insulin dosing for 3 days then monitoring for at least 3 days following will form the baseline and experiemental data for each subject. The secondary objective is to evaluate the tolerability and local and systemic effects of transdermal Human Insulin if any. ;

Study Design

NCT number NCT04857320
Study type Interventional
Source Transdermal Delivery Solutions Corp
Contact Kenneth Kirby, BA
Phone 561-429-6429
Email [email protected]
Status Recruiting
Phase Early Phase 1
Start date March 12, 2021
Completion date August 15, 2022