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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

Sponsor
Sam Chun Dang Pharm. Co. Ltd. (Industry)
Enrolment
16 planned
Conditions
Diabetes Mellitus, Type 1
Interventions
oral insulin; Placebo A; subcutaneous insulin; Placebo B
Ages
adults
Registry
NCT07634770, CTIS2024-519502-12-00

Full record on ClinicalTrials.gov

From the registry

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…

Primary outcomes

  • AUCins.0-6h, area under the serum insulin concentration curve from 0 to 6 hours
  • Cins.max, maximum observed insulin concentration
  • AUCGIR.0-6h, area under the insulin concentration-time curve from 0 to 6 hours
  • GRELcl, Relative biopotency (will be derived of the dose corrected ratio of AUCGIR.0-6h for oral and sc insulin)

History

  1. Primary completion

  2. Registered

  3. Started