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Insulin

Insulin Patch for High Blood Sugar (LEVPS Trial)

Phase 2 & 3
Waitlist Available
Led By William D. Kirsh, D.O.
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
Aged between 25 and 75 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days dosing plus 7 days post dose follow-up.
Awards & highlights

LEVPS Trial Summary

This trial looks at the effects of a transdermal human insulin patch on Type 2 diabetics, specifically how it affects glucose levels compared to injected insulin.

Who is the study for?
Adults aged 25-75 with Type 2 Diabetes using insulin (not from a pump), well-managed blood sugar levels, and no severe low blood sugar events recently. Participants must be in good health, have a BMI of 18-50 kg/m^2, take daily glucose tests with a monitor, and can't use interfering medications or have had recent significant illness.Check my eligibility
What is being tested?
The study is testing how skin-applied human insulin affects blood sugar in Type 2 Diabetics over three weeks. It's an open-label trial comparing the effects to previous responses seen with injected insulins.See study design
What are the potential side effects?
While not specified here, typical side effects of insulin therapy may include low blood sugar episodes (hypoglycemia), injection site reactions if applicable for comparison groups, weight gain, swelling in arms or legs, and allergic reactions.

LEVPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 25 and 75 years old.

LEVPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days dosing plus 7 days post dose follow-up.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days dosing plus 7 days post dose follow-up. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Glucose Time in Range for Study Participants
Secondary outcome measures
Avoidance of Hypoglycemia in Study Participants
Skin Safety in Study Participants

Side effects data

From 2015 Phase 1 trial • 24 Patients • NCT02109029
25%
Headache
13%
Presyncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A: Insulin Peglispro 4U
Part A: Insulin Peglispro 8U
Part A: Insulin Peglispro 2U
Part B: Human Insulin
Part B: Insulin Peglispro
Part A: Insulin Peglispro 6U

LEVPS Trial Design

1Treatment groups
Experimental Treatment
Group I: Main ExperimentalExperimental Treatment2 Interventions
Type 2 Diabetic patients regulating blood glucose with daily injections as basal and/or post-prandial interventions. Patients will receive transdermal product formulated at 100 IU/mL of equivalent International Units of Human Insulin dosed at the same amount as current injected therapies with timing adjusted for the Absorption, Distribution, Metabolism & Elimination (ADME) of human insulin with maximum effect at 3 hours post dose so mid morning before lunch, late afternoon before dinner and before bedtime.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Human Insulin
2013
Completed Phase 4
~290

Find a Location

Who is running the clinical trial?

Transdermal Delivery Solutions CorpLead Sponsor
4 Previous Clinical Trials
152 Total Patients Enrolled
Langford Research Institute, Inc.Industry Sponsor
1 Previous Clinical Trials
7 Total Patients Enrolled
William D. Kirsh, D.O.Principal InvestigatorUniversity of Miami

Media Library

Human Insulin (Insulin) Clinical Trial Eligibility Overview. Trial Name: NCT05159453 — Phase 2 & 3
High Blood Sugar Research Study Groups: Main Experimental
High Blood Sugar Clinical Trial 2023: Human Insulin Highlights & Side Effects. Trial Name: NCT05159453 — Phase 2 & 3
Human Insulin (Insulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05159453 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research involve middle-aged or elderly participants?

"Eligibility for this study demands that patients are aged between 25 and 75. There are 13 other trials for people younger than 18 and 114 for individuals over the age of 65."

Answered by AI

Are there other experiments that have been done using Human Insulin?

"Out of the 80 ongoing studies for Human Insulin, 13 are currently in Phase 3. The largest concentration of clinical trials is in Manhasset, New york, however there are a total of 257 locations running these tests."

Answered by AI

What is the target enrollment for this experiment?

"This study is no longer enrolling new patients. The listing was created on 1/2/2023 and last updated on 10/26/2022. If you are interested in finding other similar studies, 72 clinical trials for hyperglycemia and 80 trials for Human Insulin are currently ongoing."

Answered by AI

Are there specific enrollment criteria for this clinical trial?

"30 individuals, aged 25-75, who suffer from hyperglycemia are needed for this study. Additionally, it is essential that potential participants meet the following qualifications: the individual is willing and able to return to the study site for all visits, has a BMI of 18-50 kg/m2, requires 10-200 IU of insulin per dose, is in otherwise good health as determined by medical history and physical examination, and is willing and able to comply with all testing and requirements defined in the protocol."

Answered by AI

What goals does this experiment hope to attain?

"The primary outcome that will be monitored over the course of the 21 days is Percentage of Glucose Time in Range for Study Participants. Additionally, the trial will assess secondary outcomes including Avoidance of Hypoglycemia and Skin Safety in Study Participants."

Answered by AI

Are new patients being accepted into this experiment as we speak?

"Presently, this trial is not seeking new participants. The study was first posted on 1/2/2023 and had its last update on 10/26/2022. There are currently 72 other trials related to hyperglycemia and 80 for Human Insulin that are actively admitting patients."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Dose Response Study of Transdermal Human Insulin in Patients
2024. "Dose Response Study of Transdermal Human Insulin in Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05159453.
~19 spots leftby Dec 2024
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