Trial Outcomes & Findings for Transdermal Insulin Response In Healthy Volunteers (NCT NCT04857320)

Last Updated: 2023-10-23

Results Overview

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)"

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

7 participants

Primary outcome timeframe

Pre-dose Baseline & a Mean of readings over 3.5 hours

Results posted on

2023-10-23

Participant Flow

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.

7 Volunteers were asked to undergo a physical exam including a complete metabolic panel via blood sample.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	7
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transdermal Insulin Response In Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Main Experimental n=7 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants
Average Untreated Serum Glucose	96.4 mg/dL n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose Baseline & a Mean of readings over 3.5 hours

Population: 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.

Outcome measures

Outcome measures
Measure	Dose 1 n=5 Participants Each subject will receive doses applied to the skin of 0.075 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.	Dose 2 n=5 Participants 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.	Dose 3 n=5 Participants 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.	Subject 5 Subject received doses applied to the skin of 0.075, 0.10 and 0.15 IUs / Kilogram Body Weight per dose. Human insulin: Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 50 IU/mL of delivery vehicle.	Subject 6 Subject received doses applied to the skin of 0.075, 0.10 and 0.15 IUs / Kilogram Body Weight per dose. Human insulin: Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 50 IU/mL of delivery vehicle.
Postprandial Serum Glucose in mg/dL as a Response to Small Doses (0.075 to 0.15 IUs/Kg) Human Insulin Averaged Per Subject	3.8 mg/dL Interval -3.0 to 6.0	-1.8 mg/dL Interval -5.0 to 1.0	7 mg/dL Interval -3.0 to 9.0	—	—

PRIMARY outcome

Timeframe: 72 hours

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Dose 1 n=1 Participants Each subject will receive doses applied to the skin of 0.075 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.	Dose 2 n=1 Participants 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.	Dose 3 n=1 Participants 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.	Subject 5 n=1 Participants Subject received doses applied to the skin of 0.075, 0.10 and 0.15 IUs / Kilogram Body Weight per dose. Human insulin: Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 50 IU/mL of delivery vehicle.	Subject 6 n=1 Participants Subject received doses applied to the skin of 0.075, 0.10 and 0.15 IUs / Kilogram Body Weight per dose. Human insulin: Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 50 IU/mL of delivery vehicle.
Daily Average Serum Glucose Measured in mg/dL as a Response to Small Doses (0.075 to 0.15 IUs/Kg) Human Insulin	95 mg/dL Serum Glucose Interval 94.0 to 95.0	99 mg/dL Serum Glucose Interval 98.0 to 101.0	85 mg/dL Serum Glucose Interval 85.0 to 85.0	89 mg/dL Serum Glucose Interval 87.0 to 93.0	103 mg/dL Serum Glucose Interval 101.0 to 105.0

SECONDARY outcome

Timeframe: 20 Days

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.

Outcome measures

Outcome measures
Measure	Dose 1 n=5 Participants Each subject will receive doses applied to the skin of 0.075 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.	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.	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.	Subject 5 Subject received doses applied to the skin of 0.075, 0.10 and 0.15 IUs / Kilogram Body Weight per dose. Human insulin: Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 50 IU/mL of delivery vehicle.	Subject 6 Subject received doses applied to the skin of 0.075, 0.10 and 0.15 IUs / Kilogram Body Weight per dose. Human insulin: Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 50 IU/mL of delivery vehicle.
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	0 units on a scale Interval 0.0 to 0.0	—	—	—	—

Adverse Events

Main Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Managing Director

LANGFORD RESEARCH INSTITUTE

Phone: 5614296429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place