Dose Response Study of Transdermal Human Insulin in Patients

NCT05159453 | Not Yet Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: LEV201-D-120121
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glucose, High Blood

Outcome Measures

Primary Outcomes (1)

• Percentage of Glucose Time in Range for Study Participants

  Number of Participants who manage blood glucose in study participants to between 70 and 200 mg Glucose / dL.

  21 Days

Secondary Outcomes (2)

• Avoidance of Hypoglycemia in Study Participants

  21 days.

• Skin Safety in Study Participants

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

Study Arms (1)

Main Experimental

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.

Biological: Human Insulin; Device: Finger-actuated, Metered Pump Sprayer

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.

Also known as: Humulin(R), Novolin(R)

Main Experimental

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.

Main Experimental

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Type 2 Diabetes Mellitus ("T2D") Patients on Insulin Replacement therapy not administered via implanted pump well-managing p.r.n as defined by serum glucose ranging between 85 and 200 mg/dL and no more than 1 hypoglycemic or serious hypoglycemic event within the last 9 months.
• and 75 years of age, inclusive.
• The subject is willing and able to read and understand the Subject Information Sheet and provide written informed consent.
• The subject has a body mass index (BMI) within 18-50 kg/m2.
• The subject is in otherwise good health as determined by medical history and physical examination.
• The subject's normal insulin dose ranges from between 10 to 200 IU per dose.
• The subject must agree to continue with daily serum glucose testing by means of a wearable blood glucose monitor for the pharmacodynamic assessments that the investigators have continuous access to via daily downloads.
• The subject is willing and able to comply with all testing and requirements defined in the protocol.
• The subject is willing and able to return to the study site for all visits.

You may not qualify if:

• The subject has any relevant deviations from normal other than blood glucose in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.
• The subject has had more than 2 hypoglycemic events in the last month.
• The subject's normal insulin dose is less than 10 and more than 200 IUs.
• Subjects receiving Insulin from an implanted or external insulin pump system.
• The subject has had a clinically significant illness or surgical procedure within 30 days preceding entry into this study.
• The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease other than T2D.
• The subject has a known allergy or history of hypersensitivity to Human Insulin or similar modified Insulin compounds.
• The subject has used any prescription medication that may interfere with the evaluation of study medication.
• The subject has donated or lost a significant volume of blood (\>450 mL) within four (4) weeks of the study, and subject's Hemoglobin concentration and hematocrit have not returned to within 5% of normal.
• The subject has a history of substance abuse or a current positive urine drug screen or urine alcohol test.
• Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males).
• Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry.

Sponsors & Collaborators

• Transdermal Delivery Solutions Corp: lead
• Langford Research Institute, Inc.: collaborator

Study Sites (1)

Langford Research Institute

Palm Beach Gardens, Florida, 33410, United States

Location

MeSH Terms

Interventions

Insulin

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• William D. Kirsh, D.O.

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth B. Kirby, BA

CONTACT

5614296429; KKirby@Langfordresearch.org

William D. Kirsh, D.O.

CONTACT

786-382-3310; wkirsh@aol.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group, crossover study of insulin supplementation beginning with 2 weeks monitoring of response to injected dosing, crossover to transdermal dosing, then back to injected dosing.

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 16, 2021
• Study Start: September 2, 2025
• Primary Completion: October 15, 2025
• Study Completion: December 15, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)