Dose Response Study of Transdermal Human Insulin in Patients

Part of paid clinical trials in Palm Beach Gardens, Florida.

Sponsor
Transdermal Delivery Solutions Corp
Study ID
NCT05159453
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Glucose, High Blood

Eligibility Criteria

Sex
ALL
Age
25 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Human Insulin — BIOLOGICAL
    International Unit for International Unit exchange of transdermally delivered Human Insulin for injected Human Insulin or combinations of basal and fast-acting insulins.
  • Finger-actuated, Metered Pump Sprayer — DEVICE
    Stock, pharmaceutical grade High Density Polyethylene (HDPE) bottle and HDPE nylon and stainless steel finger-actuated pump sprayer delivering 0.2 mL per pump.

Study Details

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 Insulin as compared to historic patient response to injected insulins.

Key Dates

Start date
Sep 2, 2027
Status verified
May 2026
Primary completion
Oct 15, 2027
Completion
Dec 15, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Main Experimental
    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.

Primary Outcome Measure

Percentage of Glucose Time in Range for Study Participants [ Time Frame: 21 Days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Langford Research InstitutePalm Beach GardensFlorida33410-

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Langford Research Institute· Palm Beach Gardens, FL