Clinical trial NCT05159453: Dose Response Study of Transdermal Human Insulin in Patients
Official title: A Randomised, Multiple-Dose, Single Period, Phase II/III Dose Response Study to Examine Transdermal Human Insulin in Adult Diabetic Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Glucose, High Blood
Lead sponsor: Transdermal Delivery Solutions Corp
Sponsor class: INDUSTRY
Collaborators: name: Langford Research Institute, Inc.
First posted: 2021-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Glucose Time in Range for Study Participants
timeFrame: 21 Days
Secondary outcomes:
measure: Avoidance of Hypoglycemia in Study Participants
timeFrame: 21 days.
measure: Skin Safety in Study Participants
timeFrame: 21 days dosing plus 7 days post dose follow-up.
Other outcomes:
Locations:
city: Palm Beach Gardens
country: United States
facility: Langford Research Institute
state: Florida
Study officials:
affiliation: University of Miami
name: William D. Kirsh, D.O.
role: PRINCIPAL_INVESTIGATOR
References: