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Dose Response Study of Transdermal Human Insulin in Patients — LEVPS  

Glucose, High Blood Clinical Trial

Official title:
A Randomised, Multiple-Dose, Single Period, Phase II/III Dose Response Study to Examine Transdermal Human Insulin in Adult Diabetic Patients

Clinical Trial Summary

A 21-Day open label study of transdermally delivered human insulin in Type 2 Diabetics as measured by response of down modulation of glucose after dosing of Insulin as compared to historic patient response to injected insulins.

Clinical Trial Description

A 21-Day open label study of transdermally delivered human insulin in 30 Type 2 Diabetics is anticipated. Well-managed Type 2 Diabetics will be added to the protocol from the patient census of practicing diabetologists and family practitioners, with preference given to patients already using a wearable Continuous Glucose Monitor (CGM) system. Once added to the protocol, Subjects will be monitored via CGM for two weeks before change of dose form. Subjects will be required to calibrate the CGM against finger-stick blood sampling and to poll the monitor sensor at least every 8 hours during the 42 days of monitoring including the 21-days on-transdermal-dose study period to ensure continuity of interstitial glucose measurement. Subjects will be monitored for 7 days after the last transdermal dose to monitor interchangeability of the dose forms. Once baseline data is collected, Subjects will exchange transdermal dosing on a Unit for Unit basis. Trial materials will be formulated to a concentration of 100 IUs per mL and dispensed via 0.2 mL metered, finger-actuated pump sprayer, with each pump delivering 20 IUs of Human Insulin to the skin. If a patient, for example is currently using 120 IUs per day, 40 IUs basal insulin and 80 IUs Insulin Aspart, 120 IUs or 6 sprays would be used. The study nurse will contact each subject every day of the study to answer questions and encourage compliance with the protocol. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05159453
Study type Interventional
Source Transdermal Delivery Solutions Corp
Contact Kenneth B. Kirby, BA
Phone 5614296429
Email KKirby@Langfordresearch.org
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date January 2, 2024
Completion date February 15, 2025
View Details
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