Dose Response Study of Transdermal Human Insulin in Patients

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Insulin (regular human).

It had 1 arm (groups): Main Experimental (experimental).

The registry classes the interventions as biological and device.

More on the Plan

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.

The study nurse will contact each subject every day of the study to answer questions and encourage compliance with the protocol.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to people of any sex aged from 25 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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 is willing and able to comply with all testing and requirements defined in the protocol.

The full record lists 9 inclusion and 12 exclusion criteria; among the exclusions: the subject has had more than 2 hypoglycemic events in the last month; subjects receiving insulin from an implanted or external insulin pump system; the subject has a known allergy or history of hypersensitivity to human insulin or similar modified insulin compounds.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2027-09-02 with completion listed for 2027-10-15.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Glucose Time in Range for Study Participants (time frame: 21 Days).

It also tracked 2 secondary outcomes, for example Avoidance of Hypoglycemia in Study Participants and Skin Safety in Study Participants.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3 trial of Insulin (regular human) in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.