Glucose, High BloodPhase 2/3LEVPSNCT05159453
Dose Response Study of Transdermal Human Insulin in Patients
A Phase 2/3 study testing Human Insulin and Finger-actuated, Metered Pump Sprayer in people with Glucose, High Blood, run by Transdermal Delivery Solutions Corp at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Glucose, High Blood
- What is being tested?
- Human Insulin and Finger-actuated, Metered Pump Sprayer
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2027to 15 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 25 and 75 years of age, inclusive.
- The subject is willing and able to read and 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's normal insulin dose ranges from between 10 to 200 IU per dose.
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- 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.
- 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.
Who cannot join
- 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 more than 2 hypoglycemic events in the last month.
- The subject's normal insulin dose is less than 10 and more than 200 IUs.
- Subjects receiving Insulin from an implanted or external insulin pump system.
- The subject has had a clinically significant illness or surgical procedure 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 other than T2D.
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- 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 subject's Hemoglobin concentration and hematocrit 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Langford Research Institute
Palm Beach Gardens, Florida, 33410
About this study
Official title: A Randomised, Multiple-Dose, Single Period, Phase II/III Dose Response Study to Examine Transdermal Human Insulin in Adult Diabetic Patients
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.
Read the 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
- Being tested
- Human Insulin, Finger-actuated, Metered Pump Sprayer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human InsulinBiological
Also called Humulin(R), Novolin(R)
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 SprayerDevice
Stock, pharmaceutical grade High Density Polyethylene (HDPE) bottle and HDPE nylon and stainless steel finger-actuated pump sprayer delivering 0.2 mL per pump.
| Study group | Role | What they receive |
|---|---|---|
| Main Experimental | 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. Receives: Biological: Human Insulin; Device: Finger-actuated, Metered Pump Sprayer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Glucose Time in Range for Study Participants
Number of Participants who manage blood glucose in study participants to between 70 and 200 mg Glucose / dL.
Measured: 21 Days
Secondary outcomes (2)
Avoidance of Hypoglycemia in Study Participants
Number of study participants that manage blood glucose in study participants to more than 50 mg/dL for 86% of the 21-days-on-dose of the study period
Measured: 21 days.
Skin Safety in Study Participants
Measure of skin irritation above level 1 - erythema \& edema - according to the The Organisation for Economic Co-operation and Development (OECD) Guideline for Testing of Chemicals No. 404, adopted 17th July, 1992: "Acute Dermal Irritation/Corrosion"
Measured: 21 days dosing plus 7 days post dose follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start2 Sep 2027 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose, High BloodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transdermal Delivery Solutions Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Langford Research Institute, Inc.
- Responsible party
- Sponsor
- Investigators
- Chandan A.S. Alam, MD, Principal investigator, Langford Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159453
- Sponsor's protocol ID
- LEV201-D-120121
- Acronym
- LEVPS
- Status last verified
- May 2026
- First submitted
- 1 Dec 2021
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Multiple-Dose, Single Period, Phase II/III Dose Response Study to Examine Transdermal Human Insulin in Adult Diabetic Patients
- ClinicalTrials.gov ID
- NCT05159453
- Acronym / sponsor ID
- LEVPS / LEV201-D-120121
- Conditions
- Glucose, High Blood
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Transdermal Delivery Solutions CorpIndustry (pharma, biotech, devices)
- Collaborators
- Langford Research Institute, Inc.
- Study start
- 2 Sep 2027 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Main Experimental | Experimental | Biological: Human Insulin, Device: Finger-actuated, Metered Pump SprayerType 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 25 and 75 years of age, inclusive.
- The subject is willing and able to read and 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.
Key exclusion criteria (12 listed)
- 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 more than 2 hypoglycemic events in the last month.
- The subject's normal insulin dose is less than 10 and more than 200 IUs.
- Subjects receiving Insulin from an implanted or external insulin pump system.
- The subject has had a clinically significant illness or surgical procedure within 30 days preceding entry into this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human InsulinAlso: Humulin(R), Novolin(R)International Unit for International Unit exchange of transdermally delivered Human Insulin for injected Human Insulin or combinations of basal and fast-acting insulins. | Biological | Main Experimental |
| Finger-actuated, Metered Pump SprayerStock, pharmaceutical grade High Density Polyethylene (HDPE) bottle and HDPE nylon and stainless steel finger-actuated pump sprayer delivering 0.2 mL per pump. | Device | Main Experimental |
Primary outcome
Percentage of Glucose Time in Range for Study Participants
Time frame: 21 Days
Number of Participants who manage blood glucose in study participants to between 70 and 200 mg Glucose / dL.
2 secondary outcomes
Avoidance of Hypoglycemia in Study Participants
Time frame: 21 days.
Skin Safety in Study Participants
Time frame: 21 days dosing plus 7 days post dose follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chandan A.S. Alam, MD principal investigator
Langford Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Human Insulin and Finger-actuated, Metered Pump Sprayer in people with Glucose, High Blood, run by Transdermal Delivery Solutions Corp at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kenneth B. Kirby, BA (5614296429, KKirby@Langfordresearch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Glucose Time in Range for Study Participants (time frame: 21 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.