Bioavailability, Biopotency and Food Effect Study of SCD0503 Compared to Subcutaneous Regular Human Insulin
2 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
16
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Clinical Manager
- Número de teléfono: please reach out by email
- Correo electrónico: scd.global@scd.co.kr
Ubicaciones de estudio
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North Rhine-Westphalia
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Neuss, North Rhine-Westphalia, Alemania, 41460
- Reclutamiento
- Profil Institut für Stoffwechselforschung GmbH
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Contacto:
- Investigator
- Número de teléfono: +49213140180
- Correo electrónico: clinicaltrialservices@profil.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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)
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test product
Otros nombres:
placebo for test product
Otros nombres:
reference product/comparator
Otros nombres:
placebo for reference product
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Experimental: Sequence 2: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-Actrapid-SCD0503 medium
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test product
Otros nombres:
placebo for test product
Otros nombres:
reference product/comparator
Otros nombres:
placebo for reference product
|
|
Experimental: Sequence 3: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-SCD0503 medium-Actrapid
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test product
Otros nombres:
placebo for test product
Otros nombres:
reference product/comparator
Otros nombres:
placebo for reference product
|
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Experimental: Sequence 4: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-Actrapid-SCD0503 medium
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test product
Otros nombres:
placebo for test product
Otros nombres:
reference product/comparator
Otros nombres:
placebo for reference product
|
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Experimental: Sequence 5: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-SCD0503 medium-Actrapid
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test product
Otros nombres:
placebo for test product
Otros nombres:
reference product/comparator
Otros nombres:
placebo for reference product
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Experimental: Sequence 6: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-Actrapid-SCD0503 medium
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test product
Otros nombres:
placebo for test product
Otros nombres:
reference product/comparator
Otros nombres:
placebo for reference product
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Experimental: Sequence 7: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-SCD0503 medium-Actrapid
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test product
Otros nombres:
placebo for test product
Otros nombres:
reference product/comparator
Otros nombres:
placebo for reference product
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Experimental: Sequence 8: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-Actrapid-SCD0503 medium
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test product
Otros nombres:
placebo for test product
Otros nombres:
reference product/comparator
Otros nombres:
placebo for reference product
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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AUCins.0-6h, area under the serum insulin concentration curve from 0 to 6 hours
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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Cins.max, maximum observed insulin concentration
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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AUCGIR.0-6h, area under the insulin concentration-time curve from 0 to 6 hours
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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GRELcl, Relative biopotency (will be derived of the dose corrected ratio of AUCGIR.0-6h for oral and sc insulin)
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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AUCins.0-1h, AUCins.0-2h, AUCins.0-4h, areas under the serum insulin concentration curve in the indicated time intervals
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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tmax.ins., time to maximum observed insulin concentration
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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λz, terminal elimination rate constant of insulin
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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t½ is the terminal serum elimination half-life calculated as t½=ln2/λz
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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MRT, Mean residence time (h)
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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CL/F, Systemic clearance after oral administration (mL/min)
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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V/F, volume of distribution (L)
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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FRELcl, Relative bioavailability (will be derived from the dose corrected ratio of AUCins.0-6h for oral and sc insulin)
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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Cins.max.fed, maximum observed insulin concentration after meal test
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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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
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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FRELfed, Relative bioavailability (will be derived of the dose corrected ratio of AUCins.fed.0-6 for oral and sc insulin)
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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Food effect is investigated by comparing the total and maximum oral insulin exposure in the fasted state and after food intake
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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AUCGIR.0-1h, AUCGIR.0-2h and AUCGIR.0-4h, areas under the glucose infusion rate curve in the indicated time-intervals
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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GIRmax, maximum glucose infusion rate
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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tmax.GIR., time to maximum glucose infusion rate
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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t50%-GIR(early), time to half-maximum glucose infusion rate before GIRmax
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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t50%-GIR(late), time to half-maximum glucose infusion rate after GIRmax
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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Onset of action, time from trial product administration until plasma glucose concentration has decreased at least 5 mg/dL from baseline
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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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
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From enrollment to the end of treatment in 4 months
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PGmax, maximum plasma glucose after meal test
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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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
Periodo de tiempo: From enrollment to the end of treatment in 4 months
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From enrollment to the end of treatment in 4 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
29 de mayo de 2026
Finalización primaria (Estimado)
1 de octubre de 2026
Finalización del estudio (Estimado)
1 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
26 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de junio de 2026
Publicado por primera vez (Actual)
9 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Enfermedades metabólicas
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Enfermedades Nutricionales y Metabólicas
- Diabetes Mellitus, Tipo 1
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Hormonas peptídicas
- Péptidos
- Aminoácidos, péptidos y proteínas
- Insulina
- Hormonas pancreáticas
- Proinsulina
- Insulina
Otros números de identificación del estudio
- SCD-4E001
- 2024-519502-12 (Número EudraCT)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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