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Insulin
Human insulin for Pharmacodynamic Response to Insulin
Phase < 1
Waitlist Available
Led By William D. Kirsh, D.O., M.P.H.
Research Sponsored by Transdermal Delivery Solutions Corp
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights
Study Summary
This study is evaluating whether a formula which is applied to the skin may help improve blood sugar levels for individuals with diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Daily Average Serum Glucose Measured in mg/dL as a Response to Small Doses (0.075 to 0.15 IUs/Kg) Human Insulin
Postprandial Serum Glucose in mg/dL as a Response to Small Doses (0.075 to 0.15 IUs/Kg) Human Insulin Averaged Per Subject
Secondary outcome measures
OECD Acute Dermal Irritation/Corrosion Score According to to the Organisation for Economic Co-operation and Development (OECD) Guideline for Testing of Chemicals No. 404
Side effects data
From 2021 Phase 4 trial • 452 Patients • NCT0483436217%
Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Analog Insulin Arm
Human Insulin Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Main ExperimentalExperimental Treatment1 Intervention
Each subject will receive doses applied to the skin of 0.075 IUs / Kilogram Body Weight, 0.1 IUs/Kilogram Body Weight and 0.15 IUs /Kilogram Body Weight
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin human
FDA approved
Find a Location
Who is running the clinical trial?
Langford Research Institute, Inc.Industry Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Transdermal Delivery Solutions CorpLead Sponsor
4 Previous Clinical Trials
175 Total Patients Enrolled
William D. Kirsh, D.O., M.P.H.Principal InvestigatorLangford Research Institute
Frequently Asked Questions
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