Early Phase 1 N=7 Device Feasibility

Transdermal Insulin Response In Healthy Volunteers

Pharmacodynamic Response to Small Doses of Insulin

Bottom Line

View on ClinicalTrials.gov: NCT04857320 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2023

Primary outcome: 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 — 3.8; -1.8; 7 mg/dL — p=0.000016

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Human insulin (Combination_product)
Age: Adult · 20+ yrs
Sex: Male
Sponsor: Transdermal Delivery Solutions Corp
Primary completion: Nov 2021

Outcome Measures

Outcome	Result	p-value
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	3.8; -1.8; 7	0.000016 sig
PRIMARY Daily Average Serum Glucose Measured in mg/dL as a Response to Small Doses (0.075 to 0.15 IUs/Kg) Human Insulin	95; 99; 85; 89; 103	—
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	—	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

The subject has a serum protein HbA1c of less than 6.
The subject is willing and able to read, 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 is a non-smoker.
The subject must agree to continue with daily serum glucose testing by means of a wearable blood glucose for the pharmacokinetic assessments.
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.

Exclusion Criteria

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 a clinically significant illness 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.
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 their Haemoglobin concentration and haematocrit 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04857320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.