Type 2 Diabetes MellitusPhase 1NCT04345107

Multiple Ascending Doses of SY-009 in Type 2 Diabetes Mellitus

A Phase 1 study testing SY-009 in people with Type 2 Diabetes Mellitus, run by Suzhou Yabao Pharmaceutical R&D Co., Ltd. at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a phase Ib placebo-controlled study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of SY-009 after Multiple Ascending Doses in patients with Type 2 Diabetes Mellitus (T2DM). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: SY-009
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 4 sitesChina
Study dates: 1 May 2020to 21 Sep 2021
Phase: Phase 1
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

body weight of male ≥ 50kg, female ≥ 45kg, and body mass index (BMI) between 18.0 and 35.0 kg / m2 (including the threshold value) at screening;
Have T2DM prior to entering the trial based on the disease diagnostic criteria (WHO, 1999), and currently being treated with diet and exercise only for at last 12 weeks , or no systemic treatment of diabetes (the cumulative use of antidiabetic drugs in the past 3 months has lasted no more than 2 weeks and no antidiabetic drugs has been used in the past month);
7% ≤ HbA1c ≤ 9.5% at screening;
7 mmol/L≤FPG ≤ 13.3 mmol/L at baseline;
During the study period and within 60 days after the end of the study, the subjects has no fertility or sperm / egg donation plan and will voluntarily take effective physical contraceptive measures;
Have given written informed consent to participate in this study, are well motivated, capable, and willing to communicate with the investigator and complete all the requirements according to the protocol.

Who cannot join

Those who are known to be allergic to the test drug (including the auxiliary materials of the test drug) or its analogues, or who are allergic to two or more drugs, food and pollen, or who have taken SGLT1 or SGLT2 inhibitors in the past year;
It was diagnosed as type 1 diabetes, or gestational diabetes, or other special type diabetes;
There is enough evidence to show that there is proliferative retinopathy of active diabetes;
History of severe hypoglycemia (such as consciousness disorder and coma caused by hypoglycemia), or history of severe unconsciousness hypoglycemia;
Organ transplantation history, or other acquired, congenital immune system diseases, or peripheral vascular diseases with clinical significance;
Have significant hyperglycemia symptoms, such as polyuria, polydipsia, accidental weight loss or dehydration;

Show all 33Show fewer

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), long-term medication with direct impact on gastrointestinal peristalsis, or gastrointestinal surgery;
Have obvious blood system diseases (such as aplastic anemia, myelodysplastic syndrome), or any disease causing hemolysis or red blood cell instability (such as malaria), or accompanied by hemoglobin diseases (such as sickle type red blood cell disease) that may affect the determination of HbA1c level;
Obvious autonomic neuropathy, such as urinary retention, orthostatic hypotension, diabetic diarrhea or gastroparesis.
History of heart failure (NYHA class Ⅲ and Ⅳ, Appendix 2), or history of acute myocardial infarction or unstable angina within 6 months before screening, or history of coronary angioplasty, coronary stent implantation or coronary bypass surgery within 6 months before screening, or recent cardiac surgery plan;
Serious trauma, infection or operation that may affect blood glucose control occurred within one month before screening;
In the first two months of the screening, the drug with weight control effect was used or the operation that can lead to weight instability was performed, or the drug is currently in the weight-loss plan and is not in the maintenance stage;
Completed or withdrawn an intervention clinical trial within 3 months before screening, or is currently conducting the intervention clinical trial, or participated in other medical research activities, which is not suitable for the study according to the judgment of the researcher;
Those who frequently drink alcohol (more than 21 units (male) and 14 units / week (female) (1 unit = 360ml beer; or 150ml wine; or 45ml white wine) in the three months before screening, or who can't stop drinking during the test;
Those who are addicted to smoking (more than 10 cigarettes per day or the same amount of tobacco) within 3 months before screening or who cannot quit smoking (stop nicotine intake) during the trial;
Those who lost / donated more than 400 ml blood within 3 months before screening (except female physiological blood loss), received blood transfusion or used blood products, or planned to donate blood within 1 month (30 days) after the end of the trial or during the trial;
To screen the patients with unstable thyroid function (such as thiourea and thyroid hormone drugs) in the first 6 months, with poor control of hypothyroidism or history of hypothyroidism;
In the first 6 months of screening, there was a history of diabetic acute metabolic complications (diabetic ketoacidosis, hyperosmotic nonketotic coma, diabetic lactate acidosis);
In the screening period, when no pacemaker was installed, 12 lead ECG showed second degree or third degree atrioventricular block or qtcb interval prolonged more than 500 ms;
The results of clinical laboratory examination in screening period meet any of the following criteria:
Hemoglobin (Hgb) < lower limit of normal value (LLN);
Aspartate transaminase (AST) or alanine transaminase (ALT) > 2 times of upper limit of normal value (ULN);
Total bilirubin (TBIL) > 1.5 times the upper limit of normal value (except for known Gilbert syndrome which meets the following requirements, that is, part of bilirubin indicates that the combined bilirubin is less than 35% of total bilirubin);
Triglyceride (TG) ≥ 5.7mmol/l;
Estimated glomerular filtration rate < 60 ml / min (estimated by Cockroft Gault formula);
Fasting C peptide < 1.0 ng / ml (333 pmol / L);
Hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum antibody or human immunodeficiency virus antibody were screened positive;
Poor blood pressure control (SBP ≥ 160mmhg and / or DBP ≥ 100mmhg);
Patients with history of needle syncope, blood syncope or intolerant of venipuncture;
Those with a history of drug abuse or positive drug abuse screening;
Patients with obvious mental disorders, epilepsy and other persons without behavioral or cognitive abilities;
Female subjects in pregnancy, lactation, or with pregnancy intention, or positive pregnancy test (hCG test); and female subjects of childbearing age who can not take effective contraceptive measures (effective contraceptive measures include abstinence, sterilization, intrauterine device, or diaphragm method stipulated by local laws) during the test period;
The subject may not complete the study for other reasons or the researcher thinks it should not be included.

Trial locations and contacts

4 sites in 1 country.

China4 sites

The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210093
Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Yuncheng Central Hospital
Yuncheng, Shanxi, 044000

Other trials in China

About this study

Official title: A Phase Ib Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SY-009 After Multiple Ascending Doses in Patients With Type 2 Diabetes Mellitus

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, dose-increasing, multiple oral administration clinical trial. The planned dose escalation levels were 1, 2, 3 and 4 mg daily (6 dose groups).

After the completion of the test and safety evaluation of the initial dose of 1mg daily dose in two groups (0.5mg bid and 1mg QD), the main researchers of the team leader and the sponsor jointly determine whether to enter the 2mg daily dose study.

After the completion of the test and safety evaluation of two groups (1mg bid and 2mg QD) of 2mg daily dose, the main researchers of the group leader and the sponsor jointly determine whether to enter the 4mg daily dose study.

If the test and safety assessment of 4mg daily dose group (2mg bid) are completed and the dose termination standard is not met, the test will be terminated; if the safety assessment during or after the test reaches the dose termination standard, the study of 3mg daily dose group (1.5mg bid) will be carried out, and then the test will be terminated.

Conditions: Type 2 Diabetes Mellitus
Being tested: SY-009, SY-009 matching placebo
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-009Drug
The subjects were admitted to the clinical trial center two days before the administration period (D-2), fasted for 10 hours overnight on the day before the Administration (D-1), and banned water for 1 hour before the administration. Take sy-009 test drug or placebo immediately before meal (QD is before breakfast, bid is before breakfast and dinner) in the morning of the first day of administration, and deliver it with not more than 200ml warm boiled water. From the day 2 (D2) to the day 7 (D7) before dinner, the oral cavity of the subjects was checked for residual drugs after each administration.
SY-009 matching placeboDrug
SY-009 matching placebo

Study groups in NCT04345107
Study group	Role	What they receive
SY-009-1mg/d-1	Experimental	0.5mg BID. The subjects were given the drug for the first time before breakfast in D1, and then continued to take the drug daily until dinner in D7, and left after PD sample collection and safety assessment before breakfast in D8. Start at the same time as the SY-009-1mg/d-2 group. At the end of the two groups, the researchers will decide whether to move on to the next stage，2mg/d. Receives: Drug: SY-009
SY-009-1mg/d-2	Experimental	1mg QD.The subjects were given the drug for the first time before breakfast in D1, and then continued to take the drug daily until dinner in D7, and left after PD sample collection and safety assessment before breakfast in D8.Start at the same time as the SY-009-1mg/d-1 group. At the end of the two groups, the researchers will decide whether to move on to the next stage，2mg/d. Receives: Drug: SY-009
SY-009-2mg/d-1	Experimental	1mg BID.The subjects were given the drug for the first time before breakfast in D1, and then continued to take the drug daily until dinner in D7, and left after PD sample collection and safety assessment before breakfast in D8. Start at the same time as the SY-009-2mg/d-2 group. At the end of the two groups, the researchers will decide whether to move on to the next stage，4mg/d. Receives: Drug: SY-009
SY-009-2mg/d-2	Experimental	2mg QD.The subjects were given the drug for the first time before breakfast in D1, and then continued to take the drug daily until dinner in D7, and left after PD sample collection and safety assessment before breakfast in D8. Start at the same time as the SY-009-2mg/d-1 group. At the end of the two groups, the researchers will decide whether to move on to the next stage，4mg/d. Receives: Drug: SY-009
SY-009-4mg/d	Experimental	2mg BID.The subjects were given the drug for the first time before breakfast in D1, and then continued to take the drug daily until dinner in D7, and left after PD sample collection and safety assessment before breakfast in D8. If the test and safety assessment of 4mg daily dose group (2mg bid) are completed and the dose termination standard is not met, the test will be terminated; if the safety assessment during or after the test reaches the dose termination standard, the study of 3mg daily dose group (1.5mg bid) will be carried out, and then the test will be terminated. Receives: Drug: SY-009
SY-009-3mg/d	Experimental	1.5mg BID.The subjects were given the drug for the first time before breakfast in D1, and then continued to take the drug daily until dinner in D7, and left after PD sample collection and safety assessment before breakfast in D8, and then the test will be terminated. Receives: Drug: SY-009
SY-009 matching placebo	Placebo comparator	Oral administration of the same number of tablets in the corresponding test group. Receives: Drug: SY-009 matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum postprandial (breakfast, lunch, dinner) blood glucose added value
Compared with placebo, the maximum change in glucose from baseline at D7.
Measured: 7 days
Blood glucose AUC (AUC 0-4,AUC 4-10, AUC 10-14, AUC 0-24) in different periods.
Compared with placebo, the mean change in glucose AUC from baseline at D7.
Measured: 7 days
The Safety and tolerance of SY-009，Collecting Number of subjects with adverse events as assessed by CTCAE V5.0
Number of subjects with adverse events, major adverse events, serious adverse events, abnormal Laboratory Values, abnormal vital signs, Abnormal physical examination, Abnormal ECG data，Gastrointestinal adverse reactions (diarrhea, etc.) and hypoglycemia events
Measured: 7 days
C-peptide concentration changes before and after meal.
Compared with placebo, the mean change from baseline at D7.
Measured: 7 days
The changes of insulin concentration before and after meal.
Compared with placebo, the mean change from baseline at D7.
Measured: 7 days
GLP-1 concentration changes before and after meal.
Compared with placebo, the mean change from baseline at D7.
Measured: 7 days
GIP concentration changes before and after meal.
Compared with placebo, the mean change from baseline at D7.
Measured: 7 days

Secondary outcomes (17)

Peak concentration (Cmax)
after the first dose
Measured: 1 day
Peak time (Tmax)
after the first dose
Measured: 1 day
Terminal elimination rate constant (λ z)
after the first dose
Measured: 1 day
Terminal elimination half-life (T1 / 2)
after the first dose
Measured: 1 day
Area under the drug time curve from 0 to the last detectable time (auc0-t)
after the first dose
Measured: 1 day
Area under the drug time curve (auc0 - ∞) from 0 to infinite time
after the first dose
Measured: 1 day
Auc0 - ∞ extrapolation percentage (% aucex)
after the first dose
Measured: 1 day
Apparent clearance (CL / F)
after the first dose
Measured: 1 day
Apparent distribution volume (VZ / F).
after the first dose
Measured: 1 day
Steady state peak concentration (Cmax, SS).
After reaching steady state
Measured: 7 days
Steady state peak time (Tmax, SS).
After reaching steady state
Measured: 7 days
Steady state terminal elimination half-life (T1 / 2, SS).
After reaching steady state
Measured: 7 days
Area under drug time curve (auc0-t, SS) from steady state 0 to last detectable time.
After reaching steady state
Measured: 7 days
The area under the drug time curve (auc0 - ∞, SS) of steady state from 0 to infinite time.
After reaching steady state
Measured: 7 days
Auc0 - ∞ extrapolation percentage (% aucex)
After reaching steady state
Measured: 7 days
Accumulation ratio (rauc, rcmax)
After reaching steady state
Measured: 7 days
Stable Valley concentration (ctrough, SS).
After reaching steady state
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202021 Sep 2021

First posted14 Apr 2020
Study start1 May 2020
Primary completion29 Apr 2021
Study completion21 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Type 2 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: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04345107
Sponsor's protocol ID: SY009002
Status last verified: May 2021
First submitted: 9 Apr 2020
Last updated: 1 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Yang H, Zhang Y, Hong Y, Wei Y, Zhu Y, Huang L, Yang Y, Sun R, Li J. Effect of SY009, a novel SGLT1 inhibitor, on the plasma metabolome and bile acids in patients with type 2 diabetes mellitus. Front Endocrinol (Lausanne). 2025 Jan 28;16:1487058. doi: 10.3389/fendo.2025.1487058. eCollection 2025.
PubMed 39936104
Huang L, Cao B, Geng Y, Zhou X, Yang Y, Ma T, Lin H, Huang Z, Zhuo L, Li J. A randomized double-blind phase Ib clinical trial of SY-009 in patients with type 2 diabetes mellitus. Eur J Pharm Sci. 2024 Jan 1;192:106644. doi: 10.1016/j.ejps.2023.106644. Epub 2023 Nov 20.
PubMed 37981049

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SY-009 After Multiple Ascending Doses in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT04345107
Acronym / sponsor ID: SY009002
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd.Industry (pharma, biotech, devices)
Study start: 1 May 2020 (actual)
Primary completion: 29 Apr 2021 (actual)
Study completion: 21 Sep 2021 (actual)
First posted: 14 Apr 2020 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
SY-009-1mg/d-1	Experimental	Drug: SY-0090.5mg BID. The subjects were given the drug for the first time before breakfast in D1, and then continued to take the drug daily until dinner in D7, and left after PD sample collection and safety assessment before breakfast in D8. Start at the same time as the SY-009-1mg/d-2 group. At the end of the two groups, the researchers will decide whether to move on to the next stage，2mg/d.
SY-009-1mg/d-2	Experimental	Drug: SY-0091mg QD.The subjects were given the drug for the first time before breakfast in D1, and then continued to take the drug daily until dinner in D7, and left after PD sample collection and safety assessment before breakfast in D8.Start at the same time as the SY-009-1mg/d-1 group. At the end of the two groups, the researchers will decide whether to move on to the next stage，2mg/d.
SY-009-2mg/d-1	Experimental	Drug: SY-0091mg BID.The subjects were given the drug for the first time before breakfast in D1, and then continued to take the drug daily until dinner in D7, and left after PD sample collection and safety assessment before breakfast in D8. Start at the same time as the SY-009-2mg/d-2 group. At the end of the two groups, the researchers will decide whether to move on to the next stage，4mg/d.
SY-009-2mg/d-2	Experimental	Drug: SY-0092mg QD.The subjects were given the drug for the first time before breakfast in D1, and then continued to take the drug daily until dinner in D7, and left after PD sample collection and safety assessment before breakfast in D8. Start at the same time as the SY-009-2mg/d-1 group. At the end of the two groups, the researchers will decide whether to move on to the next stage，4mg/d.
SY-009-4mg/d	Experimental	Drug: SY-0092mg BID.The subjects were given the drug for the first time before breakfast in D1, and then continued to take the drug daily until dinner in D7, and left after PD sample collection and safety assessment before breakfast in D8. If the test and safety assessment of 4mg daily dose group (2mg bid) are completed and the dose termination standard is not met, the test will be terminated; if the safety assessment during or after the test reaches the dose termination standard, the study of 3mg daily dose group (1.5mg bid) will be carried out, and then the test will be terminated.
SY-009-3mg/d	Experimental	Drug: SY-0091.5mg BID.The subjects were given the drug for the first time before breakfast in D1, and then continued to take the drug daily until dinner in D7, and left after PD sample collection and safety assessment before breakfast in D8, and then the test will be terminated.
SY-009 matching placebo	Placebo comparator	Drug: SY-009 matching placeboOral administration of the same number of tablets in the corresponding test group.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

body weight of male ≥ 50kg, female ≥ 45kg, and body mass index (BMI) between 18.0 and 35.0 kg / m2 (including the threshold value) at screening;
Have T2DM prior to entering the trial based on the disease diagnostic criteria (WHO, 1999), and currently being treated with diet and exercise only for at last 12 weeks , or no systemic treatment of diabetes (the cumulative use of antidiabetic drugs in the past 3 months has lasted no more than 2 weeks and no antidiabetic drugs has been used in the past month);
7% ≤ HbA1c ≤ 9.5% at screening;
7 mmol/L≤FPG ≤ 13.3 mmol/L at baseline;
During the study period and within 60 days after the end of the study, the subjects has no fertility or sperm / egg donation plan and will voluntarily take effective physical contraceptive measures;

Key exclusion criteria (33 listed)

Those who are known to be allergic to the test drug (including the auxiliary materials of the test drug) or its analogues, or who are allergic to two or more drugs, food and pollen, or who have taken SGLT1 or SGLT2 inhibitors in the past year;
It was diagnosed as type 1 diabetes, or gestational diabetes, or other special type diabetes;
There is enough evidence to show that there is proliferative retinopathy of active diabetes;
History of severe hypoglycemia (such as consciousness disorder and coma caused by hypoglycemia), or history of severe unconsciousness hypoglycemia;
Organ transplantation history, or other acquired, congenital immune system diseases, or peripheral vascular diseases with clinical significance;

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-009The subjects were admitted to the clinical trial center two days before the administration period (D-2), fasted for 10 hours overnight on the day before the Administration (D-1), and banned water for 1 hour before the administration. Take sy-009 test drug or placebo immediately before meal (QD is before breakfast, bid is before breakfast and dinner) in the morning of the first day of administration, and deliver it with not more than 200ml warm boiled water. From the day 2 (D2) to the day 7 (D7) before dinner, the oral cavity of the subjects was checked for residual drugs after each administration.	Drug	SY-009-1mg/d-1, SY-009-1mg/d-2, SY-009-2mg/d-1, SY-009-2mg/d-2, SY-009-3mg/d, SY-009-4mg/d
SY-009 matching placeboSY-009 matching placebo	Drug	SY-009 matching placebo

Primary outcome

Maximum postprandial (breakfast, lunch, dinner) blood glucose added value
Time frame: 7 days
Compared with placebo, the maximum change in glucose from baseline at D7.
Blood glucose AUC (AUC 0-4,AUC 4-10, AUC 10-14, AUC 0-24) in different periods.
Time frame: 7 days
Compared with placebo, the mean change in glucose AUC from baseline at D7.
The Safety and tolerance of SY-009，Collecting Number of subjects with adverse events as assessed by CTCAE V5.0
Time frame: 7 days
Number of subjects with adverse events, major adverse events, serious adverse events, abnormal Laboratory Values, abnormal vital signs, Abnormal physical examination, Abnormal ECG data，Gastrointestinal adverse reactions (diarrhea, etc.) and hypoglycemia events
C-peptide concentration changes before and after meal.
Time frame: 7 days
Compared with placebo, the mean change from baseline at D7.
The changes of insulin concentration before and after meal.
Time frame: 7 days
Compared with placebo, the mean change from baseline at D7.
GLP-1 concentration changes before and after meal.
Time frame: 7 days
Compared with placebo, the mean change from baseline at D7.
GIP concentration changes before and after meal.
Time frame: 7 days
Compared with placebo, the mean change from baseline at D7.

17 secondary outcomes

Peak concentration (Cmax)
Time frame: 1 day
Peak time (Tmax)
Time frame: 1 day
Terminal elimination rate constant (λ z)
Time frame: 1 day
Terminal elimination half-life (T1 / 2)
Time frame: 1 day
Area under the drug time curve from 0 to the last detectable time (auc0-t)
Time frame: 1 day
Area under the drug time curve (auc0 - ∞) from 0 to infinite time
Time frame: 1 day
Auc0 - ∞ extrapolation percentage (% aucex)
Time frame: 1 day
Apparent clearance (CL / F)
Time frame: 1 day
Apparent distribution volume (VZ / F).
Time frame: 1 day
Steady state peak concentration (Cmax, SS).
Time frame: 7 days
Steady state peak time (Tmax, SS).
Time frame: 7 days
Steady state terminal elimination half-life (T1 / 2, SS).
Time frame: 7 days
Area under drug time curve (auc0-t, SS) from steady state 0 to last detectable time.
Time frame: 7 days
The area under the drug time curve (auc0 - ∞, SS) of steady state from 0 to infinite time.
Time frame: 7 days
Auc0 - ∞ extrapolation percentage (% aucex)
Time frame: 7 days
Accumulation ratio (rauc, rcmax)
Time frame: 7 days
Stable Valley concentration (ctrough, SS).
Time frame: 7 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
Derived from this study: PubMed 39936104Yang H, Zhang Y, Hong Y, Wei Y, Zhu Y, Huang L, Yang Y, Sun R, Li J. Effect of SY009, a novel SGLT1 inhibitor, on the plasma metabolome and bile acids in patients with type 2 diabetes mellitus. Front Endocrinol (Lausanne). 2025 Jan 28;16:1487058. doi: 10.3389/fendo.2025.1487058. eCollection 2025.
Derived from this study: PubMed 37981049Huang L, Cao B, Geng Y, Zhou X, Yang Y, Ma T, Lin H, Huang Z, Zhuo L, Li J. A randomized double-blind phase Ib clinical trial of SY-009 in patients with type 2 diabetes mellitus. Eur J Pharm Sci. 2024 Jan 1;192:106644. doi: 10.1016/j.ejps.2023.106644. Epub 2023 Nov 20.

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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.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SY-009 in people with Type 2 Diabetes Mellitus, run by Suzhou Yabao Pharmaceutical R&D Co., Ltd. at 4 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 6 inclusion and 33 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: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum postprandial (breakfast, lunch, dinner) blood glucose added value (time frame: 7 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04345107, which also lists 2 linked publications.

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 1 Apr 2022.