| Eligibility |
Inclusion Criteria:
- 1.Subjects have diagnosed with type 2 diabetes according to the Guidelines for
prevention and treatment of type 2 diabetes in China (2020 Edition), and have been
diagnosed with T2DM for at least 8 weeks before screening;
- 2.Aged 18 to 75 years (inclusive), no gender limitation;
- 3. Body Mass Index (BMI): 18.5=BMI=40;
- 4. No hypoglycemic drugs have been used within 8 weeks before screening, and the blood
glucose control is poor after diet and exercise therapy alone
- 5.The continuous use of insulin =14 days (except gestational diabetes), and/or the
types of hypoglycemic drugs used in combination <3 with the continuous use time =4
weeks within 1 year (more than 8 weeks) before screening;
- 6.HbA1c must meet the following criteria:
- Screening: 7.5% = HbA1c = 11.0% (Local laboratory)
- Baseline: 7.0% = HbA1c = 10.5% (Central laboratory)
- 7.Subjects of childbearing potential must use reliable methods of contraception
throughout the study period and at least 3 months after the last dose to avoid
pregnancy in female subjects or pregnancy in the male subject's partner;
- 8. Willing and able to accurately use home glucose meter for self-glucose monitoring;
- 9. Be able to understand and follow the trial procedure, voluntarily participate in
the trial and sign the informed consent form.
Exclusion Criteria:
- 1. Type 1 diabetes;
- 2. Body weight change more than 5% within 1 month prior to screening;
- 3. Received any of the following medications:
1. Prior discontinuation of DPP-4 inhibitors or GLP-1 receptor agonists for
efficacy, tolerability, and safety reasons;
2. Systemic glucocorticoid and growth hormone have been used within 8 weeks before
screening;
- 4. History of =2 episodes of grade 3 hypoglycemia within 6 months prior to screening,
or grade 3 hypoglycemia between screening to randomization;
- 5. Acute complications of diabetes, such as diabetic ketoacidosis and hyperglycemic
hyperosmolar status, occurred =1 time within 6 months prior to screening;
- 6. Severe chronic complications of diabetes (e.g., proliferative diabetic retinopathy,
severe diabetic neuropathy, diabetic foot, etc.) within 6 months prior to screening
- 7. History of acute or chronic pancreatitis prior to screening;
- 8. Subjects with clinically significant gastric emptying abnormalities (e.g., gastric
outlet obstruction), severe chronic gastrointestinal diseases (e.g., gastroparesis,
inflammatory bowel disease, or intestinal obstruction) within 6 months prior to
screening, or who have undergone gastrointestinal surgery that affects gastric
emptying;
- 9. Any of the following cardiovascular events within 6 months prior to screening:
decompensated cardiac insufficiency (NYHA class III or IV); history of unstable angina
pectoris, myocardial infarction, coronary artery bypass grafting, or coronary stent
implantation; long QT syndrome or prolonged QTcF interval (QTcF: male >450 ms, female
>470 ms) on 12-lead ECG; severe arrhythmias that are evaluated by the investigator to
be inappropriate for participation in this clinical trial;
- 10. Hemorrhagic stroke or acute ischemic stroke disease occurred within 6 months prior
to screening;
- 11. History of psychiatric diseases (such as depression, anxiety, etc.) during
screening; or symptomatic gallbladder disease; or history of other diseases that may
endanger the safety of the subject and that the investigator deems inappropriate for
enrollment;
- 12. Any type of malignant tumor treated or untreated within 5 years prior to screening
(except for clinically cured basal cell carcinoma or carcinoma in situ);
- 13. Severe or acute infection within 4 weeks prior to screening, or refractory urinary
tract or genital infection within 6 months prior to screening;
- 14. Having a significant blood system disease (e.g., aplastic anemia, myelodysplastic
syndrome) or any disease causing hemolysis or red blood cell instability (e.g.,
malaria) at screening;
- 15. Subjects with thyroid dysfunction that cannot be controlled by a stable drug dose
at screening, or with clinically significant abnormalities in thyroid function
examination results requiring drug treatment at screening;
- 16. Personal or family history of medullary thyroid cancer (MTC) or type 2 multiple
endocrine tumor syndrome at screening;
- 17. Any of the indicators meet the following criteria:
- i. Systolic blood pressure = 160mmHg or diastolic blood pressure = 100mmHg at
screening or before randomization;
- ii. Laboratory tests show any of the following abnormalities:
1. FPG=13.9 mmol/L;
2. ALT or AST=2.5×ULN;
3. Total bilirubin (TBiL) =2.0×ULN;
4. Triglyceride >5.7 mmol/L;
5. eGFR<45 mL/(min*1.73 m^2);
6. Serum amylase and/or lipase =3×ULN;
7. Hemoglobin <100 g/L;
8. Calcitonin=50 ng/L(pg/mL);
- iii. Serological examination:
1. Human immunodeficiency virus antibody or treponema pallidum antibody is positive;
2. Hepatitis C antibody is positive, and HCV RNA was higher than the lower limit of
the detection reference range;
3. Hepatitis B surface antigen is positive, and the quantitative detection result of
HBV DNA was higher than the lower limit of the detection reference range;
- 18. Known allergy to the test drug, Empagliflozin, or related excipients;
- 19. Subjects who have lost more than 400 mL blood due to blood donation or other
reasons within 3 months prior to screening;
- 20. Average alcohol intake more than 21 units of alcohol (male)/14 units of alcohol
(female) per week within the 3 months prior to screening (1 unit ˜360 mL beer, or 45
mL spirits with 40% alcohol content, or 150 mL wine);
- 21. Subject participated in any drug or medical device clinical study within 3 months
prior to screening (except for screening failure);
- 22. Pregnant or lactating female;
- 23. Not suitable for this study in the investigator's opinion.
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