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| Name | Class |
|---|---|
| Langford Research Institute, Inc. | INDUSTRY |
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Bio-fermentation produced Human insulin is available without prescription in the U.S. This study is a physician-initiated trial of a formula enabling transdermal delivery of human insulin.
The primary objective of the study is to determine the amount of lowering serum glucose as a function of dose of a topically applied formulation of Human Insulin administered by syringe measurement to adult Healthy Volunteer subjects as compared to no treatment. A 5-day period of daily blood sugar monitoring by means of wearable Continuous Glucose Monitor and insulin dosing for 3 days then monitoring for at least 3 days following will form the baseline and experimental data for each subject.
The secondary objective is to evaluate the tolerability and local and systemic effects of transdermal Human Insulin if any.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main Experimental | Experimental | Each subject will receive doses applied to the skin of 0.075 IUs / Kilogram Body Weight, 0.1 IUs/Kilogram Body Weight and 0.15 IUs /Kilogram Body Weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human insulin | Combination Product | Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 100 IU/mL of delivery vehicle. |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial Serum Glucose in mg/dL as a Response to Small Doses (0.075 to 0.15 IUs/Kg) Human Insulin Averaged Per Subject | An Average Postprandial serum glucose measured by the Continuous Glucose Monitor as a response to a single dose of Human Insulin averaged (Mean) for each Subject. Data is reported in mg/dL. The Average reported was a comparison from Baseline (Day 1) and up to 3.5 hours following each dose (assessed at Day 1 - Baseline, Day 2 - Dose 1, Day 3 - Dose 2, and Day 4 - Dose 3)" | Pre-dose Baseline & a Mean of readings over 3.5 hours |
| Daily Average Serum Glucose Measured in mg/dL as a Response to Small Doses (0.075 to 0.15 IUs/Kg) Human Insulin | Daily average serum glucose measured by the Continuous Glucose Monitor in measured in mg/dL as a response to a single dose of Human Insulin and reported by the Freestyle 14-day software. Data was collected 4 times an hour throughout the test period and across doses. The prandial segments were included in this average. Data is reported in mg/dL by subject. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| OECD Acute Dermal Irritation/Corrosion Score According to to the Organisation for Economic Co-operation and Development (OECD) Guideline for Testing of Chemicals No. 404 | The skin at the application site will be assessed at each Clinic Visit by the investigator and/or Study Nurse. Any dermal irritation will be scored according to to the Organisation for Economic Co-operation and Development (OECD) Guideline for Testing of Chemicals No. 404, adopted 17th July, 1992: "Acute Dermal Irritation/Corrosion" and any score of 0 or greater will be reported. The Guideline is a scale of from Zero (No erythema or edema), 1: Very slight, 2: Well-defined erythema/Slight edema (edges of area well-defined by definite raising), 3: Moderate to severe erythema/Moderate edema (raised approximately 1 mm) to 4: Severe erythema (beet redness) to eschar formation preventing grading / Severe edema (raised more than 1 mm, extending beyond area of exposure). The higher the score the worse the erythema or edema, so a score of 0 is very good and a score of 4 is very bad. |
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Inclusion Criteria:
Exclusion Criteria:
Male
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| Name | Affiliation | Role |
|---|---|---|
| William D. Kirsh, D.O., M.P.H. | Langford Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Langford Research Institute | Palm Beach Gardens | Florida | 33410 | United States |
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7 Volunteers were asked to undergo a physical exam including a complete metabolic panel via blood sample.
Subjects ("Ss") were recruited by word-of-mouth and attended a study orientation where the study participation expectations were discussed and the informed consent forms provided. Ss underwent a health screening to ascertain healthy, non diabetic status.
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| ID | Title | Description |
|---|---|---|
| FG000 | Main Experimental | 7 Subjects. Each subject received doses applied to the skin of 0.075 IUs / Kilogram Body Weight, 0.1 IUs/Kilogram Body Weight and 0.15 IUs /Kilogram Body Weight Human insulin: Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 100 IU/mL of delivery vehicle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Main Experimental | Each subject will receive doses applied to the skin of 0.075 IUs / Kilogram Body Weight, 0.1 IUs/Kilogram Body Weight and 0.15 IUs /Kilogram Body Weight Human insulin: Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 100 IU/mL of delivery vehicle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postprandial Serum Glucose in mg/dL as a Response to Small Doses (0.075 to 0.15 IUs/Kg) Human Insulin Averaged Per Subject | An Average Postprandial serum glucose measured by the Continuous Glucose Monitor as a response to a single dose of Human Insulin averaged (Mean) for each Subject. Data is reported in mg/dL. The Average reported was a comparison from Baseline (Day 1) and up to 3.5 hours following each dose (assessed at Day 1 - Baseline, Day 2 - Dose 1, Day 3 - Dose 2, and Day 4 - Dose 3)" | We recruited and entered 7 healthy individuals into the study. We did not include data from 2 Subjects due to non-compliance with the protocol. | Posted | Mean | Full Range | mg/dL | Pre-dose Baseline & a Mean of readings over 3.5 hours |
|
21 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Main Experimental | Each subject will receive doses applied to the skin of 0.075 IUs / Kilogram Body Weight, 0.1 IUs/Kilogram Body Weight and 0.15 IUs /Kilogram Body Weight Human insulin: Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 100 IU/mL of delivery vehicle. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Managing Director | LANGFORD RESEARCH INSTITUTE | 5614296429 | 150 | KKirby@Langfordresearch.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Apr 21, 2021 | Nov 23, 2021 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 21, 2021 | Nov 16, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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Healthy Males, aged 20 to 60, Non-diabetic and Hemoglobin A1c test results of less than 6.
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| 20 Days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Average Untreated Serum Glucose | Mean | Full Range | mg/dL |
|
| OG001 | Dose 2 | Each subject will receive doses applied to the skin of 0.10 IUs / Kilogram Body Weight. Human insulin: Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 100 IU/mL of delivery vehicle. |
| OG002 | Dose 3 | Each subject will receive doses applied to the skin of 0.15 IUs / Kilogram Body Weight. Human insulin: Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 100 IU/mL of delivery vehicle. |
|
|
|
| Primary | Daily Average Serum Glucose Measured in mg/dL as a Response to Small Doses (0.075 to 0.15 IUs/Kg) Human Insulin | Daily average serum glucose measured by the Continuous Glucose Monitor in measured in mg/dL as a response to a single dose of Human Insulin and reported by the Freestyle 14-day software. Data was collected 4 times an hour throughout the test period and across doses. The prandial segments were included in this average. Data is reported in mg/dL by subject. | 7 healthy volunteers were recruited. Data from 2 of the subjects was not included, in both cases because of lack of compliance with device polling instructions. Subjects were directed to poll the sensor at least every 8 hours and follow a typical 3 meal schedule and these 2 subjects were unable to comply and or had device issues. | Posted | Mean | Full Range | mg/dL Serum Glucose | 72 hours |
|
|
|
|
| Secondary | OECD Acute Dermal Irritation/Corrosion Score According to to the Organisation for Economic Co-operation and Development (OECD) Guideline for Testing of Chemicals No. 404 | The skin at the application site will be assessed at each Clinic Visit by the investigator and/or Study Nurse. Any dermal irritation will be scored according to to the Organisation for Economic Co-operation and Development (OECD) Guideline for Testing of Chemicals No. 404, adopted 17th July, 1992: "Acute Dermal Irritation/Corrosion" and any score of 0 or greater will be reported. The Guideline is a scale of from Zero (No erythema or edema), 1: Very slight, 2: Well-defined erythema/Slight edema (edges of area well-defined by definite raising), 3: Moderate to severe erythema/Moderate edema (raised approximately 1 mm) to 4: Severe erythema (beet redness) to eschar formation preventing grading / Severe edema (raised more than 1 mm, extending beyond area of exposure). The higher the score the worse the erythema or edema, so a score of 0 is very good and a score of 4 is very bad. | Posted | Median | Full Range | units on a scale | 20 Days |
|
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|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Subject received doses applied to the skin of 0.075, 0.10 and 0.15 IUs / Kilogram on successive days. The Subject's average Serum Glucose for these 3 days were compared against the Subject's baseline unmedicated Serum Glucose on non-dosed days. |
| t-test, 1 sided |
| 0.000003 |
| Superiority |
| t-test, 1 sided | Degrees of Freedom = 3 | 0.000002 | Superiority |
| t-test, 1 sided | Degrees of Freedom = 3 | 0.000035 | Superiority |
| t-test, 1 sided | Degrees of Freedom = 3 | 0.000004 | Superiority |