What side effects are associated with this type of intervention?

Common treatments for high blood sugar, such as insulin therapies, can cause hypoglycemia, weight gain, and injection site reactions. Metformin often leads to gastrointestinal issues like diarrhea and nausea. Sulfonylureas carry risks of hypoglycemia and weight gain. GLP-1 receptor agonists may cause gastrointestinal side effects and, rarely, pancreatitis. SGLT2 inhibitors can result in urinary tract and genital infections. Each treatment has unique side effects that should be considered when choosing the best therapy for a patient.

What prior FDA approvals exist?

The FDA has approved several treatments for high blood sugar in patients with type 2 diabetes, including various forms of insulin and other pharmacologic agents. Injectable insulins such as insulin glargine, insulin degludec, and U-500 regular insulin have been approved for their efficacy in glycemic control. Additionally, GLP-1 receptor agonists like liraglutide and extended-release exenatide, as well as SGLT2 inhibitors like dapagliflozin, have been approved for their ability to lower blood glucose levels. These treatments offer different mechanisms of action and can be tailored to individual patient needs based on efficacy, risk of hypoglycemia, and other factors.

What other types of research exist?

Promising novel alternatives to transdermal human insulin for reducing blood glucose levels in high blood sugar patients include: 1) Insulin pump therapy, which offers continuous subcutaneous insulin infusion and has shown improvements in glycemic control and quality of life. 2) Sensor-augmented insulin pump therapy, which combines continuous glucose monitoring with insulin pumps for better glucose management. 3) GLP-1 agonists, which promote weight loss and ease of dose titration, and have been effective in both type 1 and type 2 diabetes. 4) Automated insulin dosing systems, which provide optimized insulin management through advanced algorithms. These alternatives offer various benefits such as improved glycemic control, reduced hypoglycemia risk, and enhanced patient adherence.

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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

Must not have

More than 2 hypoglycemic events in the last month

History of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease other than T2D

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 days dosing plus 7 days post dose follow-up.

Awards & highlights

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 25 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a serious health condition besides type 2 diabetes.

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I lost a lot of blood recently and my blood levels haven't normalized.

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I use an insulin pump for my diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days dosing plus 7 days post dose follow-up.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Glucose Time in Range for Study Participants

Secondary study objectives

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%

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

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood sugar, such as insulin therapy, work by facilitating the uptake of glucose into cells, thereby lowering blood glucose levels. Transdermal human insulin, similar to injected insulin, helps reduce blood glucose by mimicking the body's natural insulin. Other treatments like metformin decrease hepatic glucose production and increase insulin sensitivity, while GLP-1 receptor agonists enhance insulin secretion and inhibit glucagon release. These mechanisms are essential for high blood sugar patients as they address insulin resistance and impaired insulin secretion, helping to maintain glycemic control and prevent complications.