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

2. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

16

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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)
Biologisk: oral insulin
test product
Andre navne:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Andet: Placebo A
placebo for test product
Andre navne:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologisk: subcutaneous insulin
reference product/comparator
Andre navne:
  • Actrapid
Andet: Placebo B
placebo for reference product
Eksperimentel: Sequence 2: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-Actrapid-SCD0503 medium
Biologisk: oral insulin
test product
Andre navne:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Andet: Placebo A
placebo for test product
Andre navne:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologisk: subcutaneous insulin
reference product/comparator
Andre navne:
  • Actrapid
Andet: Placebo B
placebo for reference product
Eksperimentel: Sequence 3: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-SCD0503 medium-Actrapid
Biologisk: oral insulin
test product
Andre navne:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Andet: Placebo A
placebo for test product
Andre navne:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologisk: subcutaneous insulin
reference product/comparator
Andre navne:
  • Actrapid
Andet: Placebo B
placebo for reference product
Eksperimentel: Sequence 4: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-Actrapid-SCD0503 medium
Biologisk: oral insulin
test product
Andre navne:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Andet: Placebo A
placebo for test product
Andre navne:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologisk: subcutaneous insulin
reference product/comparator
Andre navne:
  • Actrapid
Andet: Placebo B
placebo for reference product
Eksperimentel: Sequence 5: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-SCD0503 medium-Actrapid
Biologisk: oral insulin
test product
Andre navne:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Andet: Placebo A
placebo for test product
Andre navne:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologisk: subcutaneous insulin
reference product/comparator
Andre navne:
  • Actrapid
Andet: Placebo B
placebo for reference product
Eksperimentel: Sequence 6: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-Actrapid-SCD0503 medium
Biologisk: oral insulin
test product
Andre navne:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Andet: Placebo A
placebo for test product
Andre navne:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologisk: subcutaneous insulin
reference product/comparator
Andre navne:
  • Actrapid
Andet: Placebo B
placebo for reference product
Eksperimentel: Sequence 7: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-SCD0503 medium-Actrapid
Biologisk: oral insulin
test product
Andre navne:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Andet: Placebo A
placebo for test product
Andre navne:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologisk: subcutaneous insulin
reference product/comparator
Andre navne:
  • Actrapid
Andet: Placebo B
placebo for reference product
Eksperimentel: Sequence 8: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-Actrapid-SCD0503 medium
Biologisk: oral insulin
test product
Andre navne:
  • SCD0503 low dose
  • SCD0503 medium dose
  • SCD0503 high dose
Andet: Placebo A
placebo for test product
Andre navne:
  • Placebo A low dose
  • Placebo A medium dose
  • Plaebo A high dose
Biologisk: subcutaneous insulin
reference product/comparator
Andre navne:
  • Actrapid
Andet: Placebo B
placebo for reference product

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
AUCins.0-1h, AUCins.0-2h, AUCins.0-4h, areas under the serum insulin concentration curve in the indicated time intervals
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From enrollment to the end of treatment in 4 months
From enrollment to the end of treatment in 4 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sam Chun Dang Pharm. Co. Ltd.

Samarbejdspartnere

Profil Institut für Stoffwechselforschung GmbH

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. maj 2026

Primær færdiggørelse (Anslået)

1. oktober 2026

Studieafslutning (Anslået)

1. oktober 2026

Datoer for studieregistrering

Først indsendt

26. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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