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

RecruitingPhase 1Ages 18 Years - 64 YearsMaleSam Chun Dang Pharm. Co. Ltd.
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In plain words

What the trial is, and whether it could suit you

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 T

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 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
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What it tests

  • oral insulin
  • Placebo A
  • subcutaneous insulin
  • Placebo B
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Where

1 site
Profil Institut fรผr Stoffwechselforschung GmbH
Neuss, Germany
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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