Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

2 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

16

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Clinical Manager
  • Numéro de téléphone: please reach out by email
  • E-mail: scd.global@scd.co.kr

Lieux d'étude

  • Allemagne
    • North Rhine-Westphalia
      • Neuss, North Rhine-Westphalia, Allemagne, 41460
        • Recrutement
        • Profil Institut für Stoffwechselforschung GmbH
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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)
Biologique: oral insulin
test product
Autres noms:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Autre: Placebo A
placebo for test product
Autres noms:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologique: subcutaneous insulin
reference product/comparator
Autres noms:
  • Actrapide
Autre: Placebo B
placebo for reference product
Expérimental: Sequence 2: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-Actrapid-SCD0503 medium
Biologique: oral insulin
test product
Autres noms:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Autre: Placebo A
placebo for test product
Autres noms:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologique: subcutaneous insulin
reference product/comparator
Autres noms:
  • Actrapide
Autre: Placebo B
placebo for reference product
Expérimental: Sequence 3: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-SCD0503 medium-Actrapid
Biologique: oral insulin
test product
Autres noms:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Autre: Placebo A
placebo for test product
Autres noms:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologique: subcutaneous insulin
reference product/comparator
Autres noms:
  • Actrapide
Autre: Placebo B
placebo for reference product
Expérimental: Sequence 4: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-Actrapid-SCD0503 medium
Biologique: oral insulin
test product
Autres noms:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Autre: Placebo A
placebo for test product
Autres noms:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologique: subcutaneous insulin
reference product/comparator
Autres noms:
  • Actrapide
Autre: Placebo B
placebo for reference product
Expérimental: Sequence 5: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-SCD0503 medium-Actrapid
Biologique: oral insulin
test product
Autres noms:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Autre: Placebo A
placebo for test product
Autres noms:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologique: subcutaneous insulin
reference product/comparator
Autres noms:
  • Actrapide
Autre: Placebo B
placebo for reference product
Expérimental: Sequence 6: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-Actrapid-SCD0503 medium
Biologique: oral insulin
test product
Autres noms:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Autre: Placebo A
placebo for test product
Autres noms:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologique: subcutaneous insulin
reference product/comparator
Autres noms:
  • Actrapide
Autre: Placebo B
placebo for reference product
Expérimental: Sequence 7: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-SCD0503 medium-Actrapid
Biologique: oral insulin
test product
Autres noms:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Autre: Placebo A
placebo for test product
Autres noms:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologique: subcutaneous insulin
reference product/comparator
Autres noms:
  • Actrapide
Autre: Placebo B
placebo for reference product
Expérimental: Sequence 8: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-Actrapid-SCD0503 medium
Biologique: oral insulin
test product
Autres noms:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Autre: Placebo A
placebo for test product
Autres noms:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologique: subcutaneous insulin
reference product/comparator
Autres noms:
  • Actrapide
Autre: Placebo B
placebo for reference product

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
AUCins.0-6h, area under the serum insulin concentration curve from 0 to 6 hours
Délai: 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
Délai: 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
Délai: 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)
Délai: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
AUCins.0-1h, AUCins.0-2h, AUCins.0-4h, areas under the serum insulin concentration curve in the indicated time intervals
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Sam Chun Dang Pharm. Co. Ltd.

Collaborateurs

Profil Institut für Stoffwechselforschung GmbH

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 mai 2026

Achèvement primaire (Estimé)

1 octobre 2026

Achèvement de l'étude (Estimé)

1 octobre 2026

Dates d'inscription aux études

Première soumission

26 mai 2026

Première soumission répondant aux critères de contrôle qualité

2 juin 2026

Première publication (Réel)

9 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner