Type 2 diabetes
Conditions
Interventions
1mg daily dose group:The daily dose was 0.5mg BID, and 10 people were randomly assigned to receive SY-009 capsule or placebo at 4:1, which was taken orally immediately before meals.
1mg daily dose group:The daily dose was 1mg QD, and 10 people were randomly assigned to receive SY-009 capsule or placebo at 4:1, which was taken orally immediately before meals.
2mg daily dose group:The daily dose was 1mg BID, and 10 people were randomly assigned to receive SY-009 capsule or placebo at 4:1, which was taken orally immediately before meals.
2mg daily dose group:The daily dose was 2mg QD, and 10 people were randomly assigned to receive SY-009 capsule or placebo at 4:1, which was taken orally immediately before meals.
4mg daily dose group:The daily dose was 2mg BID, and 10 people were randomly assigned to receive SY-009 capsule or placebo at 4:1, which was taken orally immediately before meals.
3mg daily dose group:The daily dose was 1.5mg BID, and 10 people were randomly assigned to receive SY-009 capsule or placebo at 4:1, which was taken orally immediately before meals.
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The age of the subjects at the time of the first screening is >=18 years old, <=65 years old, gender is not limited; 2. At the time of initial screening and baseline, the subjects weighed at least 50kg for males and 45kg for females, with a body mass index (BMI) ranging from 18.0 to 35.0 kg/m2 (including the cut-off value); 3. At the time of initial screening, subjects had been diagnosed with type 2 diabetes for at least 3 months according to the 1999 WHO diagnostic criteria and classification; 4. The subjects had been receiving diet control and exercise therapy in the 3 months before the first screening, and had not received systematic treatment for diabetes during this period (the cumulative use of hypoglycemic drugs in the last 3 months was no more than 2 weeks and no use of hypoglycemic drugs in the last 1 month); 5. At the time of initial screening, the subjects' HbAlc was between 7.0% and 9.5% (including the cut-off value); 6. The fasting blood glucose of the subjects in the baseline period was between 7.0 and 13.3mmol/L (including the critical value); 7. During the study period and within 60 days after the end of the study, the subject has no plans to have children or donate sperm/egg and voluntarily takes effective physical contraception; 8. Before the trial, I have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential risks and discomfort of the trial, volunteered to participate in this clinical trial, was able to communicate well with the researchers, complied with the requirements of the whole study, and signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to the test drug (including the excipients of the test drug) or its analogues, or have an allergic constitution (such as those who are allergic to two or more drugs, food and pollen), or have taken SGLT1 within 1 year in the past or SGLT2 inhibitors; 2. Diagnosed with type 1 diabetes, or gestational diabetes, or other special types of diabetes; 3. There is sufficient evidence to show that there is active diabetic proliferative retinopathy; 4. History of severe hypoglycemia (such as disturbance of consciousness caused by hypoglycemia, coma, etc.), or history of severe unconscious hypoglycemia; 5. History of organ transplantation, or suffering from other acquired or congenital immune system diseases, or clinically significant peripheral vascular diseases; 6. People with significant hyperglycemia symptoms, such as polyuria, polydipsia, unexpected weight loss or dehydration; 7. Habitual diarrhea, irritable bowel syndrome, clinically significant gastric emptying abnormalities (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as active ulcers within 6 months), and long-term administration Drugs that directly affect gastrointestinal motility, or have undergone gastrointestinal surgery; 8. Have 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 accompanied by hemoglobinopathies that may affect the determination of HbA1c levels (such as sickle disease) red blood cell disease); 9. With obvious autonomic neuropathy, such as urinary retention, orthostatic hypotension, diabetic diarrhea or gastroparesis; history of heart failure (NYHA classification and W class, Annex 2), or acute myocardial infarction or acute myocardial infarction within 6 months before screening A history of unstable angina; or a history of coronary angioplasty, coronary stent implantation, or coronary artery bypass surgery within 6 months before screening, or a recent cardiac surgery plan; 10. History of heart failure (NYHA class and W class, Annex 2), or history of acute myocardial infarction or unstable angina within 6 months before screening; or coronary angioplasty, coronary artery disease within 6 months before screening History of stent implantation or coronary artery bypass surgery or recent cardiac surgery plan; 11. Severe trauma, serious infection or surgery that may affect blood sugar control occurred within 1 month before screening; 12. Have used drugs with weight control effect or undergone surgery that can cause weight instability within 2 months before screening, or are currently in a weight loss plan and are not in the maintenance phase; 13. Completed or withdrawn from an interventional clinical trial within 3 months before screening, or is currently undergoing an interventional clinical trial, or participated in other medical research activities, and was judged by the investigator to be inappropriate to participate in this study; 14. Regular drinking within 3 months before screening (weekly alcohol intake greater than 21 units (male) and 14 units/week (female) (1 unit = 360ml beer; or 150ml Wine; or 45ml liquor), or those who cannot abstain from alcohol during the test; 15. Smokers (more than 10 cigarettes or equivalent amount of tobacco per day) within 3 months before screening or unable to quit smoking (stop nicotine intake) during the test; 16. Those who
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum postprandial (breakfast, lunch, dinner) blood glucose increases compared with preprandial blood glucose;Measured and differential blood glucose AUC;Measured and differential values of fasting blood glucose;Measured and variable values of C peptide;Measured and variable values of insulin;Measured and variable values of GLP-1;Measured and variable values of GIP;Islet function index; | — |
Countries
China
Contacts
Public ContactLi Juan
Nanjing Drum Tower Hospital
Outcome results
None listed