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

2 giugno 2026 aggiornato da: Sam Chun Dang Pharm. Co. Ltd.

A Trial to Investigate the Relative Bioavailability, Relative Biopotency and Food Effect of SCD0503 (Oral Insulin) in Comparison to Subcutaneous Regular Human Insulin Under Euglycaemic Clamp Conditions and After Food Intake in People With Type I Diabetes

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

The sponsor of the study is developing a new insulin-based medicine that can be taken by mouth (orally). For this reason, the investigational product named SCD0503 is to be tested in the study. The sponsor wants to investigate the course of blood concentrations and the blood sugar-lowering effect of the investigational product and to find out whether SCD0503 is safe.

Investigational product tested in this study The investigational product tested, SCD0503, is still under clinical evaluation and has not yet been approved for your treatment. The active ingredient is regular human insulin, which has been used for many years in approved medicines for the treatment of diabetes. SCD0503 is being used in humans for the first time in this study.

Study procedures The study will last for approximately 1 to 4 months. During this time, the participant will come to the investigational site 8 times for visits.

During 4 visits the participant will undergo a clamp examination. The blood sugar-lowering effect of the investigational product is determined using a clamp device, a computer-controlled device that maintains blood sugar at a constant level within the normal range. This is achieved by infusing a sugar solution. During 2 further visits the participant will have a meal test. During the meal test, the blood sugar-lowering effect of the investigational product is determined after intake of a standardized meal as breakfast. You will have catheters in your arms to take blood, measure your blood sugar level and to infuse glucose (sugar) or insulin, if needed.

SCD0503 is compared with a regular human insulin already approved for the treatment of diabetes.

The participant will receive SCD0503 and the comparator product during different visits to the investigational site. The participant will also receive a placebo together with the investigational or the comparator product. The placebo looks identical but contains no active ingredient. As the investigational product is administered orally and the comparator product is injected under the skin, two placebos are used in this study.

The order of medications given will be decided by chance, using a pre-defined method called randomization (a procedure similar to flipping a coin). Neither the participant nor the study physician will know which of the 2 medicines is administered at the respective dosing occasion. However, in case of emergency, this information will be quickly available.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

16

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Germania
    • North Rhine-Westphalia
      • Neuss, North Rhine-Westphalia, Germania, 41460

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Sequence 1: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-SCD0503 medium -Actrapid
SCD0503 low dose: placebo B (subcutaneous injection)/ SCD0503 low dose + Placebo A medium dose (oral) SCD0503 medium dose: placebo B (subcutaneous injection)/ SCD0503 medium dose + Placebo A low dose (oral) SCD0503 high dose: placebo B (subcutaneous injection)/ SCD0503 high dose (oral) Actrapid: subcutaneous insulin/ Placebo A high dose (oral)
Biologico: oral insulin
test product
Altri nomi:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Altro: Placebo A
placebo for test product
Altri nomi:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologico: subcutaneous insulin
reference product/comparator
Altri nomi:
  • Actrapid
Altro: Placebo B
placebo for reference product
Sperimentale: Sequence 2: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-Actrapid-SCD0503 medium
Biologico: oral insulin
test product
Altri nomi:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Altro: Placebo A
placebo for test product
Altri nomi:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologico: subcutaneous insulin
reference product/comparator
Altri nomi:
  • Actrapid
Altro: Placebo B
placebo for reference product
Sperimentale: Sequence 3: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-SCD0503 medium-Actrapid
Biologico: oral insulin
test product
Altri nomi:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Altro: Placebo A
placebo for test product
Altri nomi:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologico: subcutaneous insulin
reference product/comparator
Altri nomi:
  • Actrapid
Altro: Placebo B
placebo for reference product
Sperimentale: Sequence 4: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-Actrapid-SCD0503 medium
Biologico: oral insulin
test product
Altri nomi:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Altro: Placebo A
placebo for test product
Altri nomi:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologico: subcutaneous insulin
reference product/comparator
Altri nomi:
  • Actrapid
Altro: Placebo B
placebo for reference product
Sperimentale: Sequence 5: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-SCD0503 medium-Actrapid
Biologico: oral insulin
test product
Altri nomi:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Altro: Placebo A
placebo for test product
Altri nomi:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologico: subcutaneous insulin
reference product/comparator
Altri nomi:
  • Actrapid
Altro: Placebo B
placebo for reference product
Sperimentale: Sequence 6: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-Actrapid-SCD0503 medium
Biologico: oral insulin
test product
Altri nomi:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Altro: Placebo A
placebo for test product
Altri nomi:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologico: subcutaneous insulin
reference product/comparator
Altri nomi:
  • Actrapid
Altro: Placebo B
placebo for reference product
Sperimentale: Sequence 7: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-SCD0503 medium-Actrapid
Biologico: oral insulin
test product
Altri nomi:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Altro: Placebo A
placebo for test product
Altri nomi:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologico: subcutaneous insulin
reference product/comparator
Altri nomi:
  • Actrapid
Altro: Placebo B
placebo for reference product
Sperimentale: Sequence 8: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-Actrapid-SCD0503 medium
Biologico: oral insulin
test product
Altri nomi:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Altro: Placebo A
placebo for test product
Altri nomi:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologico: subcutaneous insulin
reference product/comparator
Altri nomi:
  • Actrapid
Altro: Placebo B
placebo for reference product

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
AUCins.0-6h, area under the serum insulin concentration curve from 0 to 6 hours
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
Cins.max, maximum observed insulin concentration
Lasso di tempo: From enrollment to the end of treatment in 4 months
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
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
GRELcl, Relative biopotency (will be derived of the dose corrected ratio of AUCGIR.0-6h for oral and sc insulin)
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
AUCins.0-1h, AUCins.0-2h, AUCins.0-4h, areas under the serum insulin concentration curve in the indicated time intervals
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
tmax.ins., time to maximum observed insulin concentration
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
λz, terminal elimination rate constant of insulin
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
t½ is the terminal serum elimination half-life calculated as t½=ln2/λz
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
MRT, Mean residence time (h)
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
CL/F, Systemic clearance after oral administration (mL/min)
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
V/F, volume of distribution (L)
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
FRELcl, Relative bioavailability (will be derived from the dose corrected ratio of AUCins.0-6h for oral and sc insulin)
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
Cins.max.fed, maximum observed insulin concentration after meal test
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
AUCins.fed.0-1h, AUCins.fed.0-2h, AUCins.fed.0-4h, AUCins.fed.0-6h, areas under the serum insulin concentration curve in the indicated time intervals after meal test
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
FRELfed, Relative bioavailability (will be derived of the dose corrected ratio of AUCins.fed.0-6 for oral and sc insulin)
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
Food effect is investigated by comparing the total and maximum oral insulin exposure in the fasted state and after food intake
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
AUCGIR.0-1h, AUCGIR.0-2h and AUCGIR.0-4h, areas under the glucose infusion rate curve in the indicated time-intervals
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
GIRmax, maximum glucose infusion rate
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
tmax.GIR., time to maximum glucose infusion rate
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
t50%-GIR(early), time to half-maximum glucose infusion rate before GIRmax
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
t50%-GIR(late), time to half-maximum glucose infusion rate after GIRmax
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
Onset of action, time from trial product administration until plasma glucose concentration has decreased at least 5 mg/dL from baseline
Lasso di tempo: From enrollment to the end of treatment in 4 months
where baseline is defined as the mean of plasma glucose levels from -6, -4 and -2 minutes before trial product adminiadministration as measured by ClampArt
From enrollment to the end of treatment in 4 months
PGmax, maximum plasma glucose after meal test
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months
AUCPG.0-1h, AUCPG.0-2h and AUCPG.0-4h and AUCPG.0-last areas under the plasma glucose concentration curve in the indicated time-intervals
Lasso di tempo: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sam Chun Dang Pharm. Co. Ltd.

Collaboratori

Profil Institut für Stoffwechselforschung GmbH

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

29 maggio 2026

Completamento primario (Stimato)

1 ottobre 2026

Completamento dello studio (Stimato)

1 ottobre 2026

Date di iscrizione allo studio

Primo inviato

26 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SCD-4E001
  • 2024-519502-12 (Numero EudraCT)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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