Bioavailability, Biopotency and Food Effect Study of SCD0503 Compared to Subcutaneous Regular Human Insulin

What Was Tested

This registered phase 1 trial tested Insulin (regular human).

Reason for the study The participants have been diagnosed with type 1 diabetes and are being treated with standard insulin therapy.

For this reason, the investigational product named SCD0503 is to be tested in the study.

It had eight arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as biological and other.

Who Took Part

Enrollment: 16 planned participants were the target.

It was open to men only aged from 18 years up to 64 years.

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

Examples of who could join: Male person with type 1 diabetes mellitus. Age between 18 and 64 years, both inclusive. Body Mass Index (BMI) between 18.5 and 29.9 kg/m2, both inclusive. Diabetes duration of at least 12 months at the time of screening. Stable insulin regimen for at least 2 months prior to inclusion into the trial.

The full record lists 8 inclusion and 13 exclusion criteria; among the exclusions: systolic blood pressure \< 90 mmhg or \>139 mmhg and/or diastolic blood pressure \< 50 mmhg or \> 89 mmhg; heart rate at rest outside the range of 50- 90 beats per minute; proliferative retinopathy or maculopathy as judged by the investigator based on a recent (\<1 year) ophthalmologic examination.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant and investigator.

It started in 2026-05-29 with completion listed for 2026-10.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): AUCins.0-6h, area under the serum insulin concentration curve from 0 to 6 hours (time frame: From enrollment to the end of treatment in 4 months). Cins.max, maximum observed insulin concentration (time frame: From enrollment to the end of treatment in 4 months). AUCGIR.0-6h, area under the insulin concentration-time curve from 0 to 6 hours (time frame: From enrollment to the end of treatment in 4 months).

It also tracked 20 secondary outcomes, for example AUCins.0-1h, AUCins.0-2h, AUCins.0-4h, areas under the serum insulin concentration curve in the indicated time intervals, tmax.ins., time to maximum observed insulin concentration, λz, terminal elimination rate constant of insulin, t½ is the terminal serum elimination half-life calculated as t½=ln2/λz, MRT, Mean residence time (h) and CL/F, Systemic clearance after oral administration (mL/min).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 16 people.

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

It is still 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.