Transdermal Specialties Announces Success of Insulin Patch Clinical Trial
In June, 2015 TSI began the HPT-6B.3 clinical trial with 12 type-2 diabetic volunteers, both male and female subjects, who were subject to a 24 hour + test period. The trial was designed to test the new manufactured Transdermal Insulin Patch, produced at our facilities in Charlotte, NC. The Trans-Insulin patch contained 150 units of Lispro insulin and is a totally non-invasive patch, no needles.
The system is powered by an ultrasonic control device called the U-Strip Mini. Over the 24 hour period we tested the control algorithm associated with the control device, designed for active glucose reduction to 115 mg/dl and then to stabilize the patient between 95 and 115 mg/dl. In one subject we dropped their starting glucose from 304 to 112 mg/dl, a drop of -192 points and then kept them stable between 99-126 mg/dl for the rest of the day. On average we are dropping the glucose within the first 5 minutes by as much as 8 points and we achieved glucose stabilization for all the volunteers within 8 hours.
In addition there is a short video which shows insulin, marked with a blue dye, being pushed through the skin under ultrasound. In particular the ultrasound dilates the skin pore and the insulin is pushed directly into the pore, down to the dermis. From there it further transits into the blood stream, offering a very fast and steady glucose reduction.
To see how we make the patch: U-STRIP Patch Production Video
This trial provided us with all the information needed to finalize the U-Strip Insulin Delivery System for day time and night time glucose management.
Transdermal Specialties is now proceeding to screen other drugs for ultrasonic drug delivery, with 8 new formulations under test this summer alone. If you have a compound in mind for a non-invasive drug delivery application please feel free to contact us at any time.
A special thank you to the team at Thomas Jefferson University Research Center for their assistance in the testing of the U-Strip Trans-Insulin Patch.
To learn more about this emerging technology for drug delivery please refer to our web site: www.transdermalspecialties.com or contact our team in Broomall, PA. This last trial, HPT-6B.3, is the completion of our Phase-2 research. The company plans one more Phase-3 trial, leading to FDA application.
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