Insulin Patch for High Blood Sugar
(LEVPS Trial)

Recruiting in Palo Alto (17 mi)

Overseen byWilliam D. Kirsh, D.O.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Transdermal Delivery Solutions Corp

No Placebo Group

Prior Safety Data

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.

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.

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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.

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Treatment Details

Interventions

Finger-actuated, Metered Pump Sprayer (Procedure)
Human Insulin (Insulin)

Trial OverviewThe 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

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.