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Could an insulin pill replace the needle for type 1 diabetes?

NCT ID NCT07634770

Disease control Sponsor: Sam Chun Dang Pharm. Co. Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study is testing a new insulin pill (SCD0503) in 16 men with type 1 diabetes. The goal is to see how well the pill works compared to standard injected insulin and whether it is safe. Participants will have their blood sugar carefully controlled during the study to measure the pill's effects.

Why investors are watching

Sam Chun Dang Pharm. is testing SCD0503, an oral insulin pill, in a small Phase 1 trial with 16 people who have type 1 diabetes. This is the first time the drug is given to humans, so the readout will show whether an insulin pill can work at all, a key question for a small company with few other products.

If it works: If the trial shows the pill safely lowers blood sugar like injected insulin, the company could have a first-mover product in oral insulin, which would be a major asset for a small-cap firm.

If it fails: Phase 1 trials often fail on safety or effectiveness, and this is a first-in-human study, so a poor result or delay could set the program back years and hurt the company's prospects.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * HbA1c ≤ 8.5% * Fasting C-peptide \<= 0.20 nmol/L * Total insulin dose of \<1.2 (I)U/kg/day * 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 Exclusion Criteria: * 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 * Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening * Proliferative retinopathy or maculopathy as judged by the investigator based on a recent (\<1 year) ophthalmologic examination * Peripheral neuropathy * More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months pior to screening * Hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening * Significant history of alcoholism or drug abuse * Smoking more than 5 cigarettes or the equivalent per day * Tested positive for hepatitis Bs antigen * Tested positive for hepatitis C antibodies * Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen * Estimated glomerular filtration rate (eGFR) \< 60.0 mL/min/1.73m2

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 1

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Profil Institut für Stoffwechselforschung GmbH

    RECRUITING

    Neuss, North Rhine-Westphalia, 41460, Germany

    Contact Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.