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.
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%
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
Crossover
oral insulin
Biological/Vaccinetest product
Placebo A
Other interventionplacebo for test product
subcutaneous insulin
Biological/Vaccinereference product/comparator
Placebo B
Other interventionplacebo for reference product
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Treatment groupsSee each treatment group below.
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)
AUCins.0-1h, AUCins.0-2h, AUCins.0-4h, areas under the serum insulin concentration curve in the indicated time intervals
tmax.ins., time to maximum observed insulin concentration
λz, terminal elimination rate constant of insulin
t½ is the terminal serum elimination half-life calculated as t½=ln2/λz
Click on the lead sponsor to view all of their trials.
Sam Chun Dang Pharm. Co. Ltd.
Lead sponsor
Profil Institut für Stoffwechselforschung GmbH
Collaborator
