Bioavailability, Biopotency and Food Effect Study of SCD0503 Compared to Subcutaneous Regular Human Insulin
2026년 6월 2일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
16
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Clinical Manager
- 전화번호: please reach out by email
- 이메일: scd.global@scd.co.kr
연구 장소
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North Rhine-Westphalia
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Neuss, North Rhine-Westphalia, 독일, 41460
- 모병
- Profil Institut für Stoffwechselforschung GmbH
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연락하다:
- Investigator
- 전화번호: +49213140180
- 이메일: clinicaltrialservices@profil.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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
다른 이름들:
placebo for test product
다른 이름들:
reference product/comparator
다른 이름들:
placebo for reference product
|
|
실험적: Sequence 2: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-Actrapid-SCD0503 medium
|
test product
다른 이름들:
placebo for test product
다른 이름들:
reference product/comparator
다른 이름들:
placebo for reference product
|
|
실험적: Sequence 3: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-SCD0503 medium-Actrapid
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test product
다른 이름들:
placebo for test product
다른 이름들:
reference product/comparator
다른 이름들:
placebo for reference product
|
|
실험적: Sequence 4: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-Actrapid-SCD0503 medium
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test product
다른 이름들:
placebo for test product
다른 이름들:
reference product/comparator
다른 이름들:
placebo for reference product
|
|
실험적: Sequence 5: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-SCD0503 medium-Actrapid
|
test product
다른 이름들:
placebo for test product
다른 이름들:
reference product/comparator
다른 이름들:
placebo for reference product
|
|
실험적: Sequence 6: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-Actrapid-SCD0503 medium
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test product
다른 이름들:
placebo for test product
다른 이름들:
reference product/comparator
다른 이름들:
placebo for reference product
|
|
실험적: Sequence 7: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-SCD0503 medium-Actrapid
|
test product
다른 이름들:
placebo for test product
다른 이름들:
reference product/comparator
다른 이름들:
placebo for reference product
|
|
실험적: Sequence 8: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-Actrapid-SCD0503 medium
|
test product
다른 이름들:
placebo for test product
다른 이름들:
reference product/comparator
다른 이름들:
placebo for reference product
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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AUCins.0-6h, area under the serum insulin concentration curve from 0 to 6 hours
기간: 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
기간: 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
기간: 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)
기간: From enrollment to the end of treatment in 4 months
|
From enrollment to the end of treatment in 4 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
AUCins.0-1h, AUCins.0-2h, AUCins.0-4h, areas under the serum insulin concentration curve in the indicated time intervals
기간: 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
기간: 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
기간: 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
기간: 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)
기간: From enrollment to the end of treatment in 4 months
|
From enrollment to the end of treatment in 4 months
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CL/F, Systemic clearance after oral administration (mL/min)
기간: From enrollment to the end of treatment in 4 months
|
From enrollment to the end of treatment in 4 months
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V/F, volume of distribution (L)
기간: 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)
기간: 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
기간: From enrollment to the end of treatment in 4 months
|
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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: From enrollment to the end of treatment in 4 months
|
From enrollment to the end of treatment in 4 months
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tmax.GIR., time to maximum glucose infusion rate
기간: 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
기간: 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
기간: From enrollment to the end of treatment in 4 months
|
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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 29일
기본 완료 (추정된)
2026년 10월 1일
연구 완료 (추정된)
2026년 10월 1일
연구 등록 날짜
최초 제출
2026년 5월 26일
QC 기준을 충족하는 최초 제출
2026년 6월 2일
처음 게시됨 (실제)
2026년 6월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 2일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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