Oral insulin vs. subcutaneous insulin in adults with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial evaluating the pharmacokinetics, biopotency, and safety of an investigational oral insulin (SCD0503) compared to subcutaneous regular human insulin and two placebos in adults with type 1 diabetes. Participants will undergo up to several months of testing to measure blood levels of insulin and glucose response, while safety is monitored. The study includes a randomized, crossover-like design with multiple treatment arms to assess oral absorption, blood sugar effects, and tolerability under controlled conditions. Eligible participants are adults 18-64 with stable regimens and specific health criteria related to diabetes management.

Why it matters

Who can join: the full rules

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

Where it's running

• Profil Institut für Stoffwechselforschung GmbH
  Neuss, North Rhine-Westphalia, Germany Recruiting

Study contacts

• Study coordinator: Clinical Manager
• Email: scd.global@scd.co.kr
• Phone: please reach out by email

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.