Insulin Patch for High Blood Sugar

(LEVPS Trial)

Overseen By Chandan Alam

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Transdermal Delivery Solutions Corp

Must be taking: Insulin

Must not be taking: Interfering medications

Disqualifiers: Neurological, Hepatic, Renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 21 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new insulin patch for individuals with Type 2 Diabetes who currently manage their blood sugar with insulin shots. The goal is to determine if this patch, which delivers insulin through the skin, can control blood sugar levels as effectively as injections. Participants should have Type 2 Diabetes, use insulin shots without a pump, maintain stable blood sugar levels, and have experienced no more than one significant low blood sugar event in the past nine months. As a Phase 2/3 trial, this study measures the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to advancing diabetes care.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those using medications that might interfere with the study. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that insulin patches are generally safe and easy to use. These patches offer a promising option because they are applied to the skin rather than injected.

One study found that insulin patches integrate well with the body and cause minimal harm. Another study involving an insulin patch pump demonstrated its safety for people with type 1 diabetes, suggesting potential safety for those with type 2 diabetes as well.

Overall, evidence suggests that these patches provide a safe method for insulin delivery, offering encouragement to those seeking an alternative to injections. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for high blood sugar?

The insulin patch stands out because it offers a new delivery method for managing high blood sugar in type 2 diabetes. Unlike the traditional insulin injections that require needles, this patch delivers insulin through the skin, making it potentially more comfortable and convenient. Researchers are excited because the patch is designed to release insulin gradually, with peak effectiveness about three hours after application, which aligns with key meal times. This transdermal approach could improve adherence to treatment and provide more stable blood sugar control compared to injections.

What evidence suggests that this insulin patch is effective for high blood sugar?

Research has shown that insulin patches can help lower blood sugar levels in people with type 2 diabetes. In studies, about 61% of people using insulin patches achieved better blood sugar control compared to those using injections. In this trial, participants will receive a transdermal product formulated with Human Insulin, which releases insulin throughout the day to maintain steady blood sugar levels. The patches are designed for ease of use and greater convenience than daily injections. Additionally, they can adjust insulin release based on blood sugar levels, offering a flexible dosing option. Overall, insulin patches could serve as a useful alternative for managing blood sugar in type 2 diabetes. ^{1 6 7 8 9}

Who Is on the Research Team?

William D. Kirsh, D.O.

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 25 and 75 years old.

Body mass index (BMI) within 18-50 kg/m2

I have Type 2 Diabetes, use insulin (not a pump), and my blood sugar is well-controlled.

Exclusion Criteria

Any relevant deviations from normal other than blood glucose in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator

I've had more than 2 low blood sugar episodes in the last month.

I have not had a major illness or surgery in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Continuous monitoring via CGM

Treatment

Participants receive transdermal human insulin for 21 days, monitored via CGM

21 days

Daily contact with study nurse

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

Continuous monitoring via CGM

What Are the Treatments Tested in This Trial?

Interventions

• Finger-actuated, Metered Pump Sprayer
• Human Insulin

Trial Overview 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.

How Is the Trial Designed?

Group I: Main Experimental Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Transdermal Delivery Solutions Corp

Lead Sponsor

Trials

5

Recruited

180+

Langford Research Institute, Inc.

Industry Sponsor

Trials

2

Recruited

40+

Langford Research Institute, Inc.

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

Insulin pump therapy (CSII) is crucial for managing type 1 diabetes, but users face significant risks from potential errors in insulin delivery, which can lead to serious health issues like hyperglycemia or hypoglycemia.

Current safety evaluations of insulin pumps are inadequate, with limited transparency in reporting adverse events and insufficient long-term data on real-world usage, highlighting the need for improved regulatory practices and more comprehensive research on pump therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Heinemann, L., Fleming, GA., Petrie, JR., et al.[2018]

Insulin pump therapy (CSII) is crucial for managing type 1 diabetes, but it carries risks of serious complications like hyperglycemia and hypoglycemia due to various factors including pump failures and user errors.

There is a lack of transparency and sufficient data on the safety and long-term efficacy of insulin pumps, highlighting the need for better regulatory practices and more public funding for research to improve user education and prevent adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Heinemann, L., Fleming, GA., Petrie, JR., et al.[2022]

In a clinical trial involving 211 diabetic patients over 12 weeks, both Yousilin R and Novolin R significantly reduced glycosylated hemoglobin A1c (HbA1c) levels, indicating effective blood sugar control, with no significant difference between the two treatments.

The safety profiles of Yousilin R and Novolin R were comparable, with similar rates of hypoglycemic events and other adverse effects, suggesting that Yousilin R is a safe alternative to Novolin R for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The efficacy and safety of recombinant human insulin injection in the treatment of diabetic patients:a multicenter, randomized, controlled and open-labeled clinical trial]. Che, TT., Wang, X., Liu, YY., et al.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11330025/

Effectiveness, safety, and preference of transdermal insulin ... About eleven out of eighteen studies (61.1%) showed more effective blood glucose control than SC delivery, and the remaining seven studies ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6556146/

Advances in Transdermal Insulin Delivery - PMC Insulin therapy is necessary to regulate blood glucose levels for people with type 1 diabetes and commonly used in advanced type 2 diabetes.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05159453

Dose Response Study of Transdermal Human Insulin in ... 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 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0168365924001536

Glucose-responsive insulin microneedle patches for long- ... The MN patch could release insulin according to blood glucose levels (BGLs) and had excellent drug loading, more complete drug release, and good drug stability.

5. diabetesjournals.org diabetesjournals.org/spectrum/article/38/3/228/163124/Insulin-Pumps-for-Individuals-With-Type-2-Diabetes

Insulin Pumps for Individuals With Type 2 Diabetes Insulin delivery patches were developed with the intention of providing individuals with type 2 diabetes with a wearable, more user-friendly ...

6. adces.org adces.org/education/danatech/insulin-medicine-delivery/insulin-medicine-delivery-101/an-overview-of-the-bolus-only-insulin-patch

An Overview of the Bolus-Only Insulin Patch The patch is indicated for mealtime and correction bolusing in people with diabetes who are 21 years and older. For those who also need basal insulin, it may be ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9723198/

A 4-Week, Two-Center, Open-Label, Single-Arm Study to ... This study evaluated the safety and efficacy of tubeless patch pump called EOPatch in patients with well-controlled type 1 diabetes mellitus (T1DM).

8. pubs.rsc.org pubs.rsc.org/en/content/articlehtml/2025/pm/d5pm00091b

Needle-free transdermal patches for insulin delivery in ... The patch demonstrated excellent biocompatibility and low toxicity, making it a promising non-invasive alternative for transdermal insulin ...

9. webmd.com webmd.com/diabetes/what-to-know-about-insulin-patch-pumps

What to Know About Insulin Patch Pumps Diabetes pump patches are small digital devices that are modern alternatives to insulin injections.