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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests an insulin spray for Type 2 Diabetics who already use a glucose monitor. The spray delivers insulin through the skin to control blood sugar, offering an alternative to injections.

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.

What data supports the effectiveness of the insulin patch treatment for high blood sugar?

Research on a similar transdermal insulin patch in diabetic rats showed a significant decrease in blood sugar levels, suggesting that such patches can effectively deliver insulin through the skin. This supports the potential effectiveness of the insulin patch treatment for managing high blood sugar in humans. ^{1 2 3 4 5}

Is the insulin patch generally safe for humans?

Insulin delivery systems, like pumps, can have safety issues such as pump failure or user error, which might lead to high or low blood sugar levels. However, detailed safety data is often not fully shared by manufacturers, and more research is needed to understand long-term safety in real-world use. ^{6 7 8 9 10}

How does the insulin patch differ from other diabetes treatments?

The insulin patch offers a unique way to deliver insulin through the skin, potentially providing a more convenient and less invasive option compared to traditional injections. This method may improve patient compliance and comfort, as it eliminates the need for multiple daily injections. ^{7 11 12 13 14}

Research Team

William D. Kirsh, D.O.

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transdermal delivery of insulin from a novel biphasic lipid system in diabetic rats. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

U500 Disposable Patch Insulin Pump: Results and Discussion of a Veterans Affairs Pilot Study. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Dual self-regulated delivery of insulin and glucagon by a hybrid patch. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Patch Pumps: What are the advantages for people with diabetes? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Factors Affecting Performance of Insulin Pen Injector Technology: A Narrative Review. [2023]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy, safety and cost-effectiveness comparison between U-100 human regular insulin and rapid acting insulin when delivered by V-Go wearable insulin delivery device in type 2 diabetes. [2021]

8. China 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]. [2014]

9. Germany 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. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Hypoglycemic symptoms and frequency of severe hypoglycemia in patients treated with human and animal insulin preparations. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Ultra-rapid absorption of recombinant human insulin induced by zinc chelation and surface charge masking. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Role of inhaled human insulin in the management of Type 1 and 2 diabetes. [2019]

13. Scotland pubmed.ncbi.nlm.nih.gov

Glycaemic control in diabetic patients transferred from therapy with animal insulins to human crystalline zinc insulin of recombinant DNA origin: a multicentre study. [2022]

14. Spain pubmed.ncbi.nlm.nih.gov

Inhaled human insulin. [2017]