Diabetes MellitusPhase 1NCT06901726
Open, Randomized Crossover Study on PK, PD, Biopotency, and Bioavailability of Insulin Capsules in Healthy Chinese Males
A Phase 1 study testing Human insulin enteric coated capsules in dose 32mg and Human Insulin Injection in dose 5IU in people with Diabetes Mellitus, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
Pharmacokinetics and pharmacodynamics study of 2 formulations (human insulin enteric coated capsules 32mg vs. human insulin injection 5IU) Relative biopotency and bioavailability of human insulin enteric coated capsules 32mg vs. human insulin injection 5IU Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Human insulin enteric coated capsules in dose 32mg and Human Insulin Injection in dose 5IU
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2025to 1 Jun 2025
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Chinese male subjects aged 20-35 (inclusive);
- Body mass index (BMI) between 19 and 24 kg/m2 ( extrems inclusive, body mass index= body weight/ height2);
- Normal oral glucose tolerance Test (fasting plasma glucose [FPG]< 6.1 mmol/L and 2-hour postprandial blood glucose after loading with glucose [2hPG]< 7.8 mmol/L), and HbA1C<6.0%
- Normal insulin releasing test (judged by investigator);
- Considered generally healthy upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, without history of acute and chronic diseases with clinical significance, incl.: of the cardiovascular system, bronchopulmonary, neuroendocrine systems, endocrine system, as well as diseases of the gastrointestinal tract, liver, kidneys, blood, as judged by the Investigator.
- Signed informed consent and volunteers' consent to all restrictions imposed during the study.
Who cannot join
- Known allergic or suspected hypersensitivity to investigational product (IP) or related product
- Previous or existing diseases of the cardiovascular system, endocrine system, gastrointestinal system, nervous system, or diseases of the lungs, hematologic, immunology, psychiatry, and metabolic abnormalities, as judged by the investigator;
- History of heavy smoking, alcohol abuse, and drug abuse;
- Taking more than 14 units alcohol per week within 3 months prior to screening (1unit≈360 mL of beer, 45mL of spirits, or 150 mL of wine), or receiving alcohol within 48 hours prior to IP administration, or failure to abstain from alcohol during the trial;
- Receiving excessive amounts of tea, coffee, and/or caffeine rich beverages (8 or more cups, 1 cup ≈ 250 mL) per day within 3 months prior to screening;
- Use of any medication that may affect glucose lowering effect (such as oral contraceptives, corticosteroids, diuretics, adrenaline, salbutamol, glucagon, growth hormone, thyroid hormone, etc.) within 28 days prior to screening;
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- Taking any medications, vitamin products, or any Chinese herbal medicine or nutrition supplements within 2 weeks prior to IP administration;
- Participation in any clinical trial less than 3 months prior to screening or planning to participate in other trials after ICF signed.
- Blood donation or blood loss≥ 200mL of any reasons within 3 months prior to screening; history of blood transfusion or component blood transfusion; failure to guarantee not to donate whole blood / component blood (such as plasma, platelets) during the trial or within 30 days after the end of the trial;
- Undergo surgery prior to IP administration within 1month or plan to undergo surgery during the trial;
- Occurrence of acute disease during screening;
- Positive test of any: HIV-Ab, HBSAg, HCV-Ab,TP-Ab;
- History of needle phobia and blood phobia;
- Any conditions that make volunteer participation ineligible judged by investigating physician.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open, Randomized, Single Dose (32mg), Two-way Crossover Study on Pharmacokinetics, Pharmacodynamics, Relative Biopotency and Bioavailability of Human Insulin Enteric Coated Capsules in Healthy Chinese Male Subjects
Pharmacokinetics and pharmacodynamics study of 2 formulations (human insulin enteric coated capsules 32mg vs. human insulin injection 5IU) Relative biopotency and bioavailability of human insulin enteric coated capsules 32mg vs. human insulin injection 5IU
Read the detailed description
An open, randomized, single dose, two-way crossover study on Pharmacokinetics, pharmacodynamics, relative biopotency and bioavailability of human insulin enteric coated capsules in healthy Chinese male subjects using hyperinsulinemic-euglycemic clamp.
- Conditions
- Diabetes Mellitus
- Being tested
- Human insulin enteric coated capsules in dose 32mg, Human Insulin Injection in dose 5IU
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human insulin enteric coated capsules in dose 32mgDrug
Single oral administration of human insulin enteric coated capsules in dose 32mg (16 mg per capsule, two capsules).
Human Insulin Injection in dose 5IUDrug
Single subcutaneous administration of Human Insulin Injection in dose 5IU.
| Study group | Role | What they receive |
|---|---|---|
| Human insulin enteric coated capsules in dose 32mg | Experimental | Single oral administration of human insulin enteric coated capsules in dose 32mg. Receives: Drug: Human insulin enteric coated capsules in dose 32mg |
| Human Insulin Injection in dose 5 IU | Active comparator | Single subcutaneous administration of Human Insulin Injection in dose 5IU. Receives: Drug: Human Insulin Injection in dose 5IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
GIRmax
PD endpoint: The maximum glucose infusion rate
Measured: 0-11 hours (hyperinsulinemic-euglycemic clamp)
TGIRmax
PD endpoint: The time to maximum observed glucose infusion rate
Measured: 0-11 hours (hyperinsulinemic-euglycemic clamp)
AUCGIR 0-11h
PD endpoint: The area under the glucose infusion rate curve from 0 to 11 hours
Measured: 0-11 hours (hyperinsulinemic-euglycemic clamp)
AUCGIR0-∞
PD endpoint: The area under the glucose infusion rate curve from 0 to infinity
Measured: 0-11 hours (hyperinsulinemic-euglycemic clamp)
Secondary outcomes (4)
Cmax
PK endpoint: The maximum observed insulin concentration
Measured: 0-11 hours (hyperinsulinemic-euglycemic clamp)
Tmax
PK endpoint: The time to maximum observed insulin concentration
Measured: 0-11 hours (hyperinsulinemic-euglycemic clamp)
AUCIns0-11h
PK endpoint: The area under the insulin concentration curve from 0 to 11 hours
Measured: 0-11 hours (hyperinsulinemic-euglycemic clamp)
AUCIns0-∞
PK endpoint: The area under the insulin concentration-time curve from 0 hours to infinity
Measured: 0-11 hours (hyperinsulinemic-euglycemic clamp)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start31 Mar 2025 (estimated)
- Primary completion24 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- two-way crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Weiqing, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901726
- Sponsor's protocol ID
- ORA-H-CN-008
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized, Single Dose (32mg), Two-way Crossover Study on Pharmacokinetics, Pharmacodynamics, Relative Biopotency and Bioavailability of Human Insulin Enteric Coated Capsules in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT06901726
- Acronym / sponsor ID
- ORA-H-CN-008
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 24 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 30 Mar 2025 (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.
Pharmacokinetics and pharmacodynamics study of 2 formulations (human insulin enteric coated capsules 32mg vs. human insulin injection 5IU) Relative biopotency and bioavailability of human insulin enteric coated capsules 32mg vs. human insulin injection 5IU
Detailed description
An open, randomized, single dose, two-way crossover study on Pharmacokinetics, pharmacodynamics, relative biopotency and bioavailability of human insulin enteric coated capsules in healthy Chinese male subjects using hyperinsulinemic-euglycemic clamp.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two-way crossover
| Arm | Type | Receives |
|---|---|---|
| Human insulin enteric coated capsules in dose 32mg | Experimental | Drug: Human insulin enteric coated capsules in dose 32mgSingle oral administration of human insulin enteric coated capsules in dose 32mg. |
| Human Insulin Injection in dose 5 IU | Active comparator | Drug: Human Insulin Injection in dose 5IUSingle subcutaneous administration of Human Insulin Injection in dose 5IU. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy Chinese male subjects aged 20-35 (inclusive);
- Body mass index (BMI) between 19 and 24 kg/m2 ( extrems inclusive, body mass index= body weight/ height2);
- Normal oral glucose tolerance Test (fasting plasma glucose [FPG]< 6.1 mmol/L and 2-hour postprandial blood glucose after loading with glucose [2hPG]< 7.8 mmol/L), and HbA1C<6.0%
- Normal insulin releasing test (judged by investigator);
- Considered generally healthy upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, without history of acute and chronic diseases with clinical significance, incl.: of the cardiovascular system, bronchopulmonary, neuroendocrine systems, endocrine system, as well as diseases of the gastrointestinal tract, liver, kidneys, blood, as judged by the Investigator.
Key exclusion criteria (14 listed)
- Known allergic or suspected hypersensitivity to investigational product (IP) or related product
- Previous or existing diseases of the cardiovascular system, endocrine system, gastrointestinal system, nervous system, or diseases of the lungs, hematologic, immunology, psychiatry, and metabolic abnormalities, as judged by the investigator;
- History of heavy smoking, alcohol abuse, and drug abuse;
- Taking more than 14 units alcohol per week within 3 months prior to screening (1unit≈360 mL of beer, 45mL of spirits, or 150 mL of wine), or receiving alcohol within 48 hours prior to IP administration, or failure to abstain from alcohol during the trial;
- Receiving excessive amounts of tea, coffee, and/or caffeine rich beverages (8 or more cups, 1 cup ≈ 250 mL) per day within 3 months prior to screening;
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 |
|---|---|---|
| Human insulin enteric coated capsules in dose 32mgSingle oral administration of human insulin enteric coated capsules in dose 32mg (16 mg per capsule, two capsules). | Drug | Human insulin enteric coated capsules in dose 32mg |
| Human Insulin Injection in dose 5IUSingle subcutaneous administration of Human Insulin Injection in dose 5IU. | Drug | Human Insulin Injection in dose 5 IU |
Primary outcome
GIRmax
Time frame: 0-11 hours (hyperinsulinemic-euglycemic clamp)
PD endpoint: The maximum glucose infusion rate
TGIRmax
Time frame: 0-11 hours (hyperinsulinemic-euglycemic clamp)
PD endpoint: The time to maximum observed glucose infusion rate
AUCGIR 0-11h
Time frame: 0-11 hours (hyperinsulinemic-euglycemic clamp)
PD endpoint: The area under the glucose infusion rate curve from 0 to 11 hours
AUCGIR0-∞
Time frame: 0-11 hours (hyperinsulinemic-euglycemic clamp)
PD endpoint: The area under the glucose infusion rate curve from 0 to infinity
4 secondary outcomes
Cmax
Time frame: 0-11 hours (hyperinsulinemic-euglycemic clamp)
Tmax
Time frame: 0-11 hours (hyperinsulinemic-euglycemic clamp)
AUCIns0-11h
Time frame: 0-11 hours (hyperinsulinemic-euglycemic clamp)
AUCIns0-∞
Time frame: 0-11 hours (hyperinsulinemic-euglycemic clamp)
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 3 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Human insulin enteric coated capsules in dose 32mg and Human Insulin Injection in dose 5IU in people with Diabetes Mellitus, run by Shanghai Jiao Tong University School of Medicine.
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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Yifei Zhang, MD, PHD (+86-13524640378, feifei-a@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GIRmax (time frame: 0-11 hours (hyperinsulinemic-euglycemic clamp)). 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 3 Apr 2025.