NCT04857320

Transdermal Insulin Response In Healthy Volunteers

A Physician-Initiated Randomised, Multiple-Dose, Single Period, Phase II Dose Ranging Study to Examine Transdermal Human Insulin In Adult Healthy Volunteer Patients

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Transdermal Delivery Solutions Corp · Industry
• Sex: Male
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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 experimental data for each subject. The secondary objective is to evaluate the tolerability and local and systemic effects of transdermal Human Insulin if any.

Conditions

• Pharmacodynamic Response to Small Doses of Insulin

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Human insulin	Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 100 IU/mL of delivery vehicle.

Timeline

• Start date: 2021-03-12
• Primary completion: 2021-11-15
• Completion: 2021-11-15
• First posted: 2021-04-23
• Last updated: 2023-10-23
• Results posted: 2023-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study