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

Condition(s) studied

Investigational drug(s) / intervention(s)

oral insulin: test product

Placebo A: placebo for test product

subcutaneous insulin: reference product/comparator

Placebo B: placebo for reference product

Study summary

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.

Eligibility

Primary outcome measure(s)

• AUCins.0-6h, area under the serum insulin concentration curve from 0 to 6 hours — From enrollment to the end of treatment in 4 months
• Cins.max, maximum observed insulin concentration — 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 — 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) — From enrollment to the end of treatment in 4 months

Trial sites (1)

Other trials for the same condition