Bioavailability, Biopotency and Food Effect Study of SCD0503 Compared to Subcutaneous Regular Human Insulin
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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Clinical Manager
- 電話番号：please reach out by email
- メール：scd.global@scd.co.kr
研究場所
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North Rhine-Westphalia
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Neuss、North Rhine-Westphalia、ドイツ、41460
- 募集
- Profil Institut für Stoffwechselforschung GmbH
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コンタクト：
- Investigator
- 電話番号：+49213140180
- メール：clinicaltrialservices@profil.com
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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
他の名前：
placebo for test product
他の名前：
reference product/comparator
他の名前：
placebo for reference product
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実験的：Sequence 2: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-Actrapid-SCD0503 medium
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test product
他の名前：
placebo for test product
他の名前：
reference product/comparator
他の名前：
placebo for reference product
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実験的：Sequence 3: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-SCD0503 medium-Actrapid
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test product
他の名前：
placebo for test product
他の名前：
reference product/comparator
他の名前：
placebo for reference product
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実験的：Sequence 4: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-Actrapid-SCD0503 medium
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test product
他の名前：
placebo for test product
他の名前：
reference product/comparator
他の名前：
placebo for reference product
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実験的：Sequence 5: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-SCD0503 medium-Actrapid
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test product
他の名前：
placebo for test product
他の名前：
reference product/comparator
他の名前：
placebo for reference product
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実験的：Sequence 6: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-Actrapid-SCD0503 medium
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test product
他の名前：
placebo for test product
他の名前：
reference product/comparator
他の名前：
placebo for reference product
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実験的：Sequence 7: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-SCD0503 medium-Actrapid
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test product
他の名前：
placebo for test product
他の名前：
reference product/comparator
他の名前：
placebo for reference product
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実験的：Sequence 8: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-Actrapid-SCD0503 medium
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test product
他の名前：
placebo for test product
他の名前：
reference product/comparator
他の名前：
placebo for reference product
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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AUCins.0-6h, area under the serum insulin concentration curve from 0 to 6 hours
時間枠：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
時間枠：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
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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