Type 2 DiabetesPhase 2NCT05426018
The Efficacy and Safety of Different Doses of SY-009 in Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing SY-009 capsules in people with Type 2 Diabetes, run by Suzhou Yabao Pharmaceutical R&D Co., Ltd. at 7 sites in China.
Trial summary
SY-009 is a novel compound that inhibits sodium glucose cotransporter-1 (SGLT-1). The preclinical and phase 1 clinical trial data support to carry out phase II clinical trial in diabetes subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- SY-009 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 7 sitesChina
- Study dates
- 1 Jul 2022to 1 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects were ≥ 18 years old and ≤ 75 years old at the first screening (visit 1);
- At the first screening (visit 1) and the baseline period (visit 3), male weight ≥ 50kg, female weight ≥ 45kg, and body mass index (BMI) between 18.0 and 35.0 kg/m2 (including the critical value);
- At the first screening (visit 1), the subjects had been diagnosed with type 2 diabetes for at least 3 months according to the WHO diagnostic criteria and classification in 1999;
- The subjects had been receiving diet control and exercise therapy for 3 months before the first screening (visit 1), and had not received systematic treatment for diabetes during this period (the cumulative use of hypoglycemic drugs in recent 3 months was not more than 2 weeks, and no hypoglycemic drugs were used in recent 1 month);
- The subjects' HbA1c at the first screening (visit 1) was between 7.5% and 10.5% (including the critical value); During the baseline period (visit 3), HbA1c was between 7.0% and 10.5% (including the critical value);
- Subjects' fasting blood glucose ≤ 13.3mmol/l in the baseline period (visit 3);
- Before the trial, the nature, significance, possible benefits, possible inconvenience, potential risks and discomfort of the trial have been understood in detail, and they have volunteered to participate in the clinical trial. They can communicate well with researchers, comply with the requirements of the whole trial, and have signed a written informed consent.
Who cannot join
- Known allergic to the test drug (including the excipients of the test drug) or its analogues, or allergic constitution (such as allergic to two or more drugs, food and pollen), or having taken SGLT-1 or sglt-2 inhibitors in the past 1 year;
- Received long-term (>2 weeks) systemic glucocorticoid therapy (excluding topical, ophthalmic or inhaled preparations) within 3 months before screening;
- Diagnosed as type 1 diabetes, or gestational diabetes, or other special types of diabetes;
- There is sufficient evidence of active diabetes proliferative retinopathy;
- History of severe hypoglycemia (such as consciousness disorder and coma caused by hypoglycemia), or history of serious unconscious hypoglycemia;
- History of acute metabolic complications of diabetes within 6 months before screening (diabetes ketoacidosis, hypertonic non ketoacidosis coma, diabetes lactic acidosis);
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- Serious trauma, serious infection or operation that may affect blood glucose control occurred within 1 month before screening;
- There are obvious blood system diseases (such as aplastic anemia, myelodysplastic syndrome), or any disease that causes hemolysis or red blood cell instability (such as malaria), or hemoglobinopathy that may affect the determination of HbA1c level (such as sickle cell disease);
- Have obvious autonomic neuropathy, such as urinary retention, postural hypotension, diabetes diarrhea or gastroparesis；
- Habitual diarrhea, irritable bowel syndrome, clinically significant abnormal gastric emptying (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as active ulcer within 6 months) or gastrointestinal surgery within 3 months before screening;
- History of organ transplantation (excluding corneal transplantation), or other acquired or congenital immune system diseases, or clinically significant peripheral vascular diseases;
- History of heart failure (NYHA grade III and IV), or history of acute myocardial infarction or unstable angina pectoris within 6 months before screening; Or have a history of coronary angioplasty, coronary stent implantation or coronary artery bypass surgery within 6 months before screening or have a recent cardiac surgery plan;
- In the screening period, when no pacemaker was installed, grade II or III atrioventricular block or qtcb interval was prolonged >500 MS in 12 lead ECG;
- Patients with abnormal thyroid function (such as thiourea and thyroid hormone drugs) whose treatment dose was not stable within the first 6 months were screened; Hypothyroidism with poor control or history of hypothyroidism;
- Unstable weight (weight change more than 5kg) within 2 months before screening, or used drugs with weight control effect or performed surgery that can lead to unstable weight, or is currently in the weight loss plan and is not in the maintenance stage;
- Poor blood pressure control (systolic blood pressure (SBP) ≥ 160mmhg and / or diastolic blood pressure (DBP) ≥ 100 mmHg);
- At the first screening (visit 1), the subjects were positive for HBsAg, HCV antibody, Treponema pallidum antibody or human immunodeficiency virus antibody;
- The clinical laboratory test results at the first screening (visit 1) and the baseline period (visit 3) meet any of the following criteria: 1） Hemoglobin (Hgb) < 100g/l; 2） Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper limit of normal value (ULN);3） Total bilirubin (TBIL) > 1.5 times the upper limit of normal value (except for the known Gilbert syndrome that meets the following requirements, that is, part of bilirubin indicates conjugated bilirubin < 35% of total bilirubin); 4） Triglyceride (TG) ≥ 5.7mmol/l; 5） Estimated glomerular filtration rate < 60 ml/min (estimated by CKD-EPI formula);
- Regular drinking (weekly alcohol intake greater than 21 units (male) and 14 units / week (female) (1 unit = 360ml beer; 150ml wine; or 45ml Baijiu) within 3 months before screening, or unable to quit drinking during the test;
- Those who lost more than 400 ml of blood / donated blood (except physiological blood loss of women) within 3 months before screening, received blood transfusion or used blood products, or planned to donate blood during the test or within 1 month (30 days) after the end of the test;
- Patients with a history of needle fainting, blood fainting or inability to tolerate venipuncture；
- History of drug abuse, drug abuse and addiction;
- Patients with obvious mental disorders, epilepsy and other persons without behavioral ability or cognitive ability;
- History of malignant tumor or currently suffering from any malignant tumor;
- Female subjects in pregnancy, lactation or pregnancy test (blood HCG test) positive; And the subjects have fertility or sperm / egg donation plans during the test period and within 60 days after the end of the test and cannot take effective physical contraceptive measures (effective contraceptive measures include abstinence, sterilization, intrauterine device, or diaphragm method stipulated by local laws);
- An intervention clinical trial has been completed or withdrawn within 1 month before screening, or is currently undergoing an intervention clinical trial, or has participated in other medical research activities, which is not suitable to participate in this trial according to the judgment of the researcher;
- The subjects may not be able to complete the test for other reasons or the researchers think they should not be included.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
The Second Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
Gaoyou Lv, 13695552978
Changsha Central Hospital
Changsha, Hunan
Chengdu Fifth People's Hospital
Chengdu, Sichan
Hongyi Cao, 13730683979
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Zhihong Wang, 13883021919
Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang
Qiuling Zhang, 18989873772
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Tianyou Pan, 15305609568, TianyouPan@163.com
The first hospital of Hebei Medical University
Shijiazhuang, Hebei
Huimin Zhou, 13331369900
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Trial Evaluate the Efficacy and Safety of Oral Administration of Different Doses of SY-009 Capsule in Patients With T2DM for 12 Weeks
SY-009 is a novel compound that inhibits sodium glucose cotransporter-1 (SGLT-1). The preclinical and phase 1 clinical trial data support to carry out phase II clinical trial in diabetes subjects.
- Conditions
- Type 2 Diabetes
- Being tested
- SY-009 capsules
- Keywords
- Sodium glucose cotransporter-1 (SGLT-1) inhibitor
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SY-009 capsulesDrug
3 capsules each time (3 test drugs), 3 times a day (oral administration before breakfast, lunch, dinner or with meals)
| Study group | Role | What they receive |
|---|---|---|
| SY-009 -1 | Experimental | 0.5mg tid Receives: Drug: SY-009 capsules |
| SY-009-2 | Experimental | 1.0mg tid Receives: Drug: SY-009 capsules |
| SY-009-3 | Experimental | 1.5mg tid Receives: Drug: SY-009 capsules |
| Placebo | Placebo comparator | tid Receives: Drug: SY-009 capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of HbA1c compared with baseline at 12 weeks
Changes of HbA1c in each dose group compared with baseline at 12 weeks of treatment
Measured: 12 weeks
Secondary outcomes (16)
Changes of HbA1c compared with baseline at 8 weeks
Changes of HbA1c in each dose group compared with baseline at 8 weeks of treatment
Measured: 8 weeks
Changes of maximum blood glucose increase (0-180min) after breakfast compared with baseline at 12 weeks
Changes of maximum blood glucose increase (0-180min) after breakfast in each dose group compared with baseline at 12 weeks of treatment
Measured: 12 weeks
Proportion of subjects with HbA1c ≤ 7%
Measured: 8 weeks，12 weeks
Proportion of subjects with HbA1c ≤ 6.5%
Measured: 8 weeks，12 weeks
Changes of blood glucose at 2h after breakfast compared with baseline
Measured: 12 weeks
Changes of insulin at 2h after breakfast compared with baseline
Measured: 12 weeks
Changes of C-peptide at 2h after breakfast compared with baseline
Measured: 12 weeks
Change of GLP-1 from baseline 2h after breakfast
Measured: 12 weeks
Change of GIP from baseline 2h after breakfast
Measured: 12 weeks
Change of mean fasting blood glucose from baseline
Measured: 12 weeks
Change of fasting blood glucose from baseline
Measured: 4 weeks，8 weeks，12 weeks
change of mean blood glucose value at 7 time points from baseline
Based on SMPG test,the change of mean blood glucose value at 7 time points from baseline
Measured: 4 weeks，8 weeks，12 weeks
Changes of blood glucose at 2h after meal compared with baseline
Based on SMPG test,the Changes of blood glucose at 2h after meal (breakfast, lunch and dinner) compared with baseline
Measured: 4 weeks，8 weeks，12 weeks
Changes in insulin resistance (HOMA-IR) from baseline
Measured: 12 weeks
Islet of Langerhans β Cellular function (HOMA- β） Change from baseline
Measured: 12 weeks
Blood drug concentration level
Measured: 4 weeks，8 weeks，12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426018
- Sponsor's protocol ID
- SY009003
- Status last verified
- May 2022
- First submitted
- 15 Jun 2022
- Last updated
- 21 Jun 2022
- 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 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Trial Evaluate the Efficacy and Safety of Oral Administration of Different Doses of SY-009 Capsule in Patients With T2DM for 12 Weeks
- ClinicalTrials.gov ID
- NCT05426018
- Acronym / sponsor ID
- SY009003
- Conditions
- Type 2 Diabetes
- Keywords
- Sodium glucose cotransporter-1 (SGLT-1) inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 21 Jun 2022 (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.
SY-009 is a novel compound that inhibits sodium glucose cotransporter-1 (SGLT-1). The preclinical and phase 1 clinical trial data support to carry out phase II clinical trial in diabetes subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SY-009 -1 | Experimental | Drug: SY-009 capsules0.5mg tid |
| SY-009-2 | Experimental | Drug: SY-009 capsules1.0mg tid |
| SY-009-3 | Experimental | Drug: SY-009 capsules1.5mg tid |
| Placebo | Placebo comparator | Drug: SY-009 capsulestid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects were ≥ 18 years old and ≤ 75 years old at the first screening (visit 1);
- At the first screening (visit 1) and the baseline period (visit 3), male weight ≥ 50kg, female weight ≥ 45kg, and body mass index (BMI) between 18.0 and 35.0 kg/m2 (including the critical value);
- At the first screening (visit 1), the subjects had been diagnosed with type 2 diabetes for at least 3 months according to the WHO diagnostic criteria and classification in 1999;
- The subjects had been receiving diet control and exercise therapy for 3 months before the first screening (visit 1), and had not received systematic treatment for diabetes during this period (the cumulative use of hypoglycemic drugs in recent 3 months was not more than 2 weeks, and no hypoglycemic drugs were used in recent 1 month);
- The subjects' HbA1c at the first screening (visit 1) was between 7.5% and 10.5% (including the critical value); During the baseline period (visit 3), HbA1c was between 7.0% and 10.5% (including the critical value);
Key exclusion criteria (27 listed)
- Known allergic to the test drug (including the excipients of the test drug) or its analogues, or allergic constitution (such as allergic to two or more drugs, food and pollen), or having taken SGLT-1 or sglt-2 inhibitors in the past 1 year;
- Received long-term (>2 weeks) systemic glucocorticoid therapy (excluding topical, ophthalmic or inhaled preparations) within 3 months before screening;
- Diagnosed as type 1 diabetes, or gestational diabetes, or other special types of diabetes;
- There is sufficient evidence of active diabetes proliferative retinopathy;
- History of severe hypoglycemia (such as consciousness disorder and coma caused by hypoglycemia), or history of serious unconscious hypoglycemia;
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 |
|---|---|---|
| SY-009 capsules3 capsules each time (3 test drugs), 3 times a day (oral administration before breakfast, lunch, dinner or with meals) | Drug | Placebo, SY-009 -1, SY-009-2, SY-009-3 |
Primary outcome
Changes of HbA1c compared with baseline at 12 weeks
Time frame: 12 weeks
Changes of HbA1c in each dose group compared with baseline at 12 weeks of treatment
16 secondary outcomes
Changes of HbA1c compared with baseline at 8 weeks
Time frame: 8 weeks
Changes of maximum blood glucose increase (0-180min) after breakfast compared with baseline at 12 weeks
Time frame: 12 weeks
Proportion of subjects with HbA1c ≤ 7%
Time frame: 8 weeks，12 weeks
Proportion of subjects with HbA1c ≤ 6.5%
Time frame: 8 weeks，12 weeks
Changes of blood glucose at 2h after breakfast compared with baseline
Time frame: 12 weeks
Changes of insulin at 2h after breakfast compared with baseline
Time frame: 12 weeks
Changes of C-peptide at 2h after breakfast compared with baseline
Time frame: 12 weeks
Change of GLP-1 from baseline 2h after breakfast
Time frame: 12 weeks
Change of GIP from baseline 2h after breakfast
Time frame: 12 weeks
Change of mean fasting blood glucose from baseline
Time frame: 12 weeks
Change of fasting blood glucose from baseline
Time frame: 4 weeks，8 weeks，12 weeks
change of mean blood glucose value at 7 time points from baseline
Time frame: 4 weeks，8 weeks，12 weeks
Changes of blood glucose at 2h after meal compared with baseline
Time frame: 4 weeks，8 weeks，12 weeks
Changes in insulin resistance (HOMA-IR) from baseline
Time frame: 12 weeks
Islet of Langerhans β Cellular function (HOMA- β） Change from baseline
Time frame: 12 weeks
Blood drug concentration level
Time frame: 4 weeks，8 weeks，12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
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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. This study is not recruiting at the moment.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SY-009 capsules in people with Type 2 Diabetes, run by Suzhou Yabao Pharmaceutical R&D Co., Ltd. at 7 sites in China.
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 7 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalong Zhu, DR (13805150781, zhudalong@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of HbA1c compared with baseline at 12 weeks (time frame: 12 weeks). 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 21 Jun 2022.