A Phase 1 interventional study of oral insulin and Placebo A in Diabetes Mellitus, Type 1, sponsored by Sam Chun Dang Pharm. Co. Ltd.. Recruiting at 1 site in Germany. Open to male participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Sam Chun Dang Pharm. Co. Ltd. · Phase 1, Interventional, and Basic science
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 16 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Sam Chun Dang Pharm. Co. Ltd. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Biological: oral insulin · Other: Placebo A · Biological: subcutaneous insulin · Other: Placebo B
Biological: oral insulin · Other: Placebo A · Biological: subcutaneous insulin · Other: Placebo B
Biological: oral insulin · Other: Placebo A · Biological: subcutaneous insulin · Other: Placebo B
Biological: oral insulin · Other: Placebo A · Biological: subcutaneous insulin · Other: Placebo B
Biological: oral insulin · Other: Placebo A · Biological: subcutaneous insulin · Other: Placebo B
Biological: oral insulin · Other: Placebo A · Biological: subcutaneous insulin · Other: Placebo B
Biological: oral insulin · Other: Placebo A · Biological: subcutaneous insulin · Other: Placebo B
Biological: oral insulin · Other: Placebo A · Biological: subcutaneous insulin · Other: Placebo B
test product
Also known as: SCD0503 low dose, SCD0503 medium dose, SCD0503 high dose
placebo for test product
Also known as: Placebo A low dose, Placebo A medium dose, Plaebo A high dose
reference product/comparator
Also known as: Actrapid
placebo for reference product
AUCins.0-6h, area under the serum insulin concentration curve from 0 to 6 hours
Time frame: From enrollment to the end of treatment in 4 months
Cins.max, maximum observed insulin concentration
Time frame: 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
Time frame: 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)
Time frame: From enrollment to the end of treatment in 4 months
AUCins.0-1h, AUCins.0-2h, AUCins.0-4h, areas under the serum insulin concentration curve in the indicated time intervals
Time frame: From enrollment to the end of treatment in 4 months
tmax.ins., time to maximum observed insulin concentration
Time frame: From enrollment to the end of treatment in 4 months
λz, terminal elimination rate constant of insulin
Time frame: From enrollment to the end of treatment in 4 months
t½ is the terminal serum elimination half-life calculated as t½=ln2/λz
Time frame: From enrollment to the end of treatment in 4 months
MRT, Mean residence time (h)
Time frame: From enrollment to the end of treatment in 4 months
CL/F, Systemic clearance after oral administration (mL/min)
Time frame: From enrollment to the end of treatment in 4 months
V/F, volume of distribution (L)
Time frame: 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)
Time frame: From enrollment to the end of treatment in 4 months
Cins.max.fed, maximum observed insulin concentration after meal test
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From enrollment to the end of treatment in 4 months
GIRmax, maximum glucose infusion rate
Time frame: From enrollment to the end of treatment in 4 months
tmax.GIR., time to maximum glucose infusion rate
Time frame: From enrollment to the end of treatment in 4 months
t50%-GIR(early), time to half-maximum glucose infusion rate before GIRmax
Time frame: From enrollment to the end of treatment in 4 months
t50%-GIR(late), time to half-maximum glucose infusion rate after GIRmax
Time frame: 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
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
Time frame: From enrollment to the end of treatment in 4 months
PGmax, maximum plasma glucose after meal test
Time frame: 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
Time frame: From enrollment to the end of treatment in 4 months
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Sam Chun Dang Pharm. Co. Ltd.