Diabetes Mellitus, Type 1Phase 1NCT07634770
Bioavailability, Biopotency and Food Effect Study of SCD0503 Compared to Subcutaneous Regular Human Insulin
A Phase 1 study testing oral insulin and subcutaneous insulin in people with Diabetes Mellitus, Type 1, run by Sam Chun Dang Pharm. Co. Ltd. at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- oral insulin and subcutaneous insulin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 29 May 2026to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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%
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Profil Institut für Stoffwechselforschung GmbH
Neuss, North Rhine-Westphalia, 41460
Investigator, +49213140180, clinicaltrialservices@profil.com
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- oral insulin, Placebo A, subcutaneous insulin, Placebo B
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral insulinBiological
Also called SCD0503 low dose, SCD0503 medium dose, SCD0503 high dose
test product
Placebo AOther
Also called Placebo A low dose, Placebo A medium dose, Plaebo A high dose
placebo for test product
subcutaneous insulinBiological
Also called Actrapid
reference product/comparator
Placebo BOther
placebo for reference product
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-SCD0503 medium -Actrapid | Experimental | 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) Receives: Biological: oral insulin; Other: Placebo A; Biological: subcutaneous insulin; Other: Placebo B |
| Sequence 2: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-Actrapid-SCD0503 medium | Experimental | Not described Receives: Biological: oral insulin; Other: Placebo A; Biological: subcutaneous insulin; Other: Placebo B |
| Sequence 3: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-SCD0503 medium-Actrapid | Experimental | Not described Receives: Biological: oral insulin; Other: Placebo A; Biological: subcutaneous insulin; Other: Placebo B |
| Sequence 4: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-Actrapid-SCD0503 medium | Experimental | Not described Receives: Biological: oral insulin; Other: Placebo A; Biological: subcutaneous insulin; Other: Placebo B |
| Sequence 5: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-SCD0503 medium-Actrapid | Experimental | Not described Receives: Biological: oral insulin; Other: Placebo A; Biological: subcutaneous insulin; Other: Placebo B |
| Sequence 6: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-Actrapid-SCD0503 medium | Experimental | Not described Receives: Biological: oral insulin; Other: Placebo A; Biological: subcutaneous insulin; Other: Placebo B |
| Sequence 7: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-SCD0503 medium-Actrapid | Experimental | Not described Receives: Biological: oral insulin; Other: Placebo A; Biological: subcutaneous insulin; Other: Placebo B |
| Sequence 8: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-Actrapid-SCD0503 medium | Experimental | Not described Receives: Biological: oral insulin; Other: Placebo A; Biological: subcutaneous insulin; Other: Placebo B |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCins.0-6h, area under the serum insulin concentration curve from 0 to 6 hours
Measured: From enrollment to the end of treatment in 4 months
Cins.max, maximum observed insulin concentration
Measured: 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
Measured: 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)
Measured: From enrollment to the end of treatment in 4 months
Secondary outcomes (20)
AUCins.0-1h, AUCins.0-2h, AUCins.0-4h, areas under the serum insulin concentration curve in the indicated time intervals
Measured: From enrollment to the end of treatment in 4 months
tmax.ins., time to maximum observed insulin concentration
Measured: From enrollment to the end of treatment in 4 months
λz, terminal elimination rate constant of insulin
Measured: From enrollment to the end of treatment in 4 months
t½ is the terminal serum elimination half-life calculated as t½=ln2/λz
Measured: From enrollment to the end of treatment in 4 months
MRT, Mean residence time (h)
Measured: From enrollment to the end of treatment in 4 months
CL/F, Systemic clearance after oral administration (mL/min)
Measured: From enrollment to the end of treatment in 4 months
V/F, volume of distribution (L)
Measured: 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)
Measured: From enrollment to the end of treatment in 4 months
Cins.max.fed, maximum observed insulin concentration after meal test
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: From enrollment to the end of treatment in 4 months
GIRmax, maximum glucose infusion rate
Measured: From enrollment to the end of treatment in 4 months
tmax.GIR., time to maximum glucose infusion rate
Measured: From enrollment to the end of treatment in 4 months
t50%-GIR(early), time to half-maximum glucose infusion rate before GIRmax
Measured: From enrollment to the end of treatment in 4 months
t50%-GIR(late), time to half-maximum glucose infusion rate after GIRmax
Measured: 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
Measured: From enrollment to the end of treatment in 4 months
PGmax, maximum plasma glucose after meal test
Measured: 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
Measured: From enrollment to the end of treatment in 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start29 May 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sam Chun Dang Pharm. Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634770
- Sponsor's protocol ID
- SCD-4E001
- Other IDs
- 2024-519502-12
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07634770
- Acronym / sponsor ID
- SCD-4E001
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Sam Chun Dang Pharm. Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH
- Study start
- 29 May 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-SCD0503 medium -Actrapid | Experimental | Biological: oral insulin, Other: Placebo A, Biological: subcutaneous insulin, Other: Placebo BSCD0503 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) |
| Sequence 2: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-Actrapid-SCD0503 medium | Experimental | Biological: oral insulin, Other: Placebo A, Biological: subcutaneous insulin, Other: Placebo B |
| Sequence 3: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-SCD0503 medium-Actrapid | Experimental | Biological: oral insulin, Other: Placebo A, Biological: subcutaneous insulin, Other: Placebo B |
| Sequence 4: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-Actrapid-SCD0503 medium | Experimental | Biological: oral insulin, Other: Placebo A, Biological: subcutaneous insulin, Other: Placebo B |
| Sequence 5: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-SCD0503 medium-Actrapid | Experimental | Biological: oral insulin, Other: Placebo A, Biological: subcutaneous insulin, Other: Placebo B |
| Sequence 6: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-Actrapid-SCD0503 medium | Experimental | Biological: oral insulin, Other: Placebo A, Biological: subcutaneous insulin, Other: Placebo B |
| Sequence 7: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-SCD0503 medium-Actrapid | Experimental | Biological: oral insulin, Other: Placebo A, Biological: subcutaneous insulin, Other: Placebo B |
| Sequence 8: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-Actrapid-SCD0503 medium | Experimental | Biological: oral insulin, Other: Placebo A, Biological: subcutaneous insulin, Other: Placebo B |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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%
- Fasting C-peptide <= 0.20 nmol/L
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral insulinAlso: SCD0503 low dose, SCD0503 medium dose, SCD0503 high dosetest product | Biological | Sequence 1: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-SCD0503 medium -Actrapid, Sequence 2: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-Actrapid-SCD0503 medium, Sequence 3: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-SCD0503 medium-Actrapid, Sequence 4: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-Actrapid-SCD0503 medium, Sequence 5: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-SCD0503 medium-Actrapid, Sequence 6: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-Actrapid-SCD0503 medium, Sequence 7: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-SCD0503 medium-Actrapid, Sequence 8: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-Actrapid-SCD0503 medium |
| Placebo AAlso: Placebo A low dose, Placebo A medium dose, Plaebo A high doseplacebo for test product | Other | Sequence 1: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-SCD0503 medium -Actrapid, Sequence 2: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-Actrapid-SCD0503 medium, Sequence 3: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-SCD0503 medium-Actrapid, Sequence 4: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-Actrapid-SCD0503 medium, Sequence 5: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-SCD0503 medium-Actrapid, Sequence 6: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-Actrapid-SCD0503 medium, Sequence 7: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-SCD0503 medium-Actrapid, Sequence 8: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-Actrapid-SCD0503 medium |
| subcutaneous insulinAlso: Actrapidreference product/comparator | Biological | Sequence 1: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-SCD0503 medium -Actrapid, Sequence 2: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-Actrapid-SCD0503 medium, Sequence 3: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-SCD0503 medium-Actrapid, Sequence 4: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-Actrapid-SCD0503 medium, Sequence 5: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-SCD0503 medium-Actrapid, Sequence 6: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-Actrapid-SCD0503 medium, Sequence 7: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-SCD0503 medium-Actrapid, Sequence 8: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-Actrapid-SCD0503 medium |
| Placebo Bplacebo for reference product | Other | Sequence 1: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-SCD0503 medium -Actrapid, Sequence 2: SCD0503 low dose-SCD0503 medium dose-Actrapid-SCD0503 high dose-Actrapid-SCD0503 medium, Sequence 3: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-SCD0503 medium-Actrapid, Sequence 4: SCD0503 medium dose-SCD0503 high dose-SCD0503 low dose-Actrapid-Actrapid-SCD0503 medium, Sequence 5: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-SCD0503 medium-Actrapid, Sequence 6: SCD0503 high dose-Actrapid-SCD0503 medium dose-SCD0503 low dose-Actrapid-SCD0503 medium, Sequence 7: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-SCD0503 medium-Actrapid, Sequence 8: Actrapid-SCD0503 low dose-SCD0503 high dose-SCD0503 medium dose-Actrapid-SCD0503 medium |
Primary outcome
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
20 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oral insulin and subcutaneous insulin in people with Diabetes Mellitus, Type 1, run by Sam Chun Dang Pharm. Co. Ltd. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Manager (please reach out by email, scd.global@scd.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.