Dose Response Study of Transdermal Human Insulin in Patients

NCT ID: NCT05159453

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-02
• Study Completion Date: 2025-12-15

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.

Detailed Description

A 21-Day open label study of transdermally delivered human insulin in 30 Type 2 Diabetics is anticipated. Well-managed Type 2 Diabetics will be added to the protocol from the patient census of practicing diabetologists and family practitioners, with preference given to patients already using a wearable Continuous Glucose Monitor (CGM) system. Once added to the protocol, Subjects will be monitored via CGM for two weeks before change of dose form. Subjects will be required to calibrate the CGM against finger-stick blood sampling and to poll the monitor sensor at least every 8 hours during the 42 days of monitoring including the 21-days on-transdermal-dose study period to ensure continuity of interstitial glucose measurement. Subjects will be monitored for 7 days after the last transdermal dose to monitor interchangeability of the dose forms.

Once baseline data is collected, Subjects will exchange transdermal dosing on a Unit for Unit basis. Trial materials will be formulated to a concentration of 100 IUs per mL and dispensed via 0.2 mL metered, finger-actuated pump sprayer, with each pump delivering 20 IUs of Human Insulin to the skin. If a patient, for example is currently using 120 IUs per day, 40 IUs basal insulin and 80 IUs Insulin Aspart, 120 IUs or 6 sprays would be used.

The study nurse will contact each subject every day of the study to answer questions and encourage compliance with the protocol.

Conditions

Glucose, High Blood

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Human Insulin

Intervention Type: 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

Intervention Type: 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.

Interventions

Human Insulin

International Unit for International Unit exchange of transdermally delivered Human Insulin for injected Human Insulin or combinations of basal and fast-acting insulins.

Intervention Type: BIOLOGICAL

Finger-actuated, Metered Pump Sprayer

Stock, pharmaceutical grade High Density Polyethylene (HDPE) bottle and HDPE nylon and stainless steel finger-actuated pump sprayer delivering 0.2 mL per pump.

Intervention Type: DEVICE

Other Intervention Names

Humulin(R); Novolin(R)

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 25 and 75 years of age, inclusive.

3. The subject is willing and able to read and understand the Subject Information Sheet and provide written informed consent.

4. The subject has a body mass index (BMI) within 18-50 kg/m2.

5. The subject is in otherwise good health as determined by medical history and physical examination.

6. The subject's normal insulin dose ranges from between 10 to 200 IU per dose.

7. 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.

8. The subject is willing and able to comply with all testing and requirements defined in the protocol.

9. The subject is willing and able to return to the study site for all visits.

Exclusion Criteria

1. 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.

2. The subject has had more than 2 hypoglycemic events in the last month.

3. The subject's normal insulin dose is less than 10 and more than 200 IUs.

4. Subjects receiving Insulin from an implanted or external insulin pump system.

5. The subject has had a clinically significant illness or surgical procedure within 30 days preceding entry into this study.

6. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease other than T2D.

7. The subject has a known allergy or history of hypersensitivity to Human Insulin or similar modified Insulin compounds.

8. The subject has used any prescription medication that may interfere with the evaluation of study medication.

9. 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.

10. The subject has a history of substance abuse or a current positive urine drug screen or urine alcohol test.

11. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males).

12. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Langford Research Institute, Inc.

INDUSTRY

Sponsor Role: collaborator

Transdermal Delivery Solutions Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William D. Kirsh, D.O.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Langford Research Institute

Palm Beach Gardens, Florida, United States

Countries

United States

Central Contacts

Kenneth B. Kirby, BA

Role: CONTACT

KKirby@Langfordresearch.org

5614296429

William D. Kirsh, D.O.

Role: CONTACT

wkirsh@aol.com

786-382-3310

Other Identifiers

LEV201-D-120121

Identifier Type: -

Identifier Source: org_study_id