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Dose Response Study of Transdermal Human Insulin in Patients

NCT05159453 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-11-21

No results posted yet for this study

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.

Conditions

  • Glucose, High Blood

Interventions

BIOLOGICAL

Human Insulin

International Unit for International Unit exchange of transdermally delivered Human Insulin for injected Human Insulin or combinations of basal and fast-acting insulins.

DEVICE

Finger-actuated, Metered Pump Sprayer

Stock, pharmaceutical grade High Density Polyethylene (HDPE) bottle and HDPE nylon and stainless steel finger-actuated pump sprayer delivering 0.2 mL per pump.

Sponsors & Collaborators

  • Langford Research Institute, Inc.

    collaborator INDUSTRY

  • Transdermal Delivery Solutions Corp

    lead INDUSTRY

Principal Investigators

  • William D. Kirsh, D.O. · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-02
Primary Completion
2025-10-15
Completion
2025-12-15
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05159453 on ClinicalTrials.gov