Diabetes mellitus
Conditions
Interventions
Group 1:Yogliptin Tablet, 200mg continue to administrate for 12 weeks
Group 2:Yogliptin Tablet, 300mg continue to administrate for 12 weeks
Group 3:Yogliptin Tablet, 400mg continue to administrate for 12 weeks
control group:Yogliptin Placebo continue to administrate for 12 weeks
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form; 2. Subjects who meet the World Health Organization(WHO) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes; 3. Aged 18 to 70 years, male or female; 4. 19kg/m^2 = 7.5 to <= 10.5% at screening; 6. Centralised HbA1c at the end of run-in period7.0% <= HbA1c <= 10.0%; 7. FPG < 13.9mmol/L(250mg/dL) at screening; 8. Patients need to meet the following requirements before screening: (1) diagnosis of type 2 diabetes for no more than 3 years and no more than 3 months; (2) lifestyle is basically stable within 3 months before screening; 9. No regular oral hypoglycemic drugs or the use of injectable preparations, or only the lowest dose of a single hypoglycemic drug in clinical treatment, the above are continuous use of less than or equal to 7 days; 10.Able to comply with the restrictions and requirements of the study protocol and able to complete the study in the opinion of the investigator.
Exclusion criteria
Exclusion criteria: 1. History of type 1 diabetes or secondary diabetes; 2. History of acute diabetic complications such as ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), or lactic acidosis; 3. Experienced serious diabetic complications such as retinopathy into proliferative phase, neuropathy with painful neuropathy, vascular lesions more than 50% occluded, eGFR = 500 ms during the screening period or at baseline; 8. Poor blood pressure control, SBP > 160 mmHg and/or DBP > 100 mmHg at screening or baseline; 9. Patients whose laboratory test results meet the following criteria: (1) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 2.5 times the upper limit of normal range (UNL), total bilirubin (TBIL) >= 2.0 times the upper limit of normal range; (2) glomerular filtration rate (eGFR) 5.6 mmol/L; 10. Patients with one or more positive results of hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody and treponema pallidum antibody; 11. DPP-4 inhibitors, GLP-1 receptor agonists within 3 months prior to screening; 12. Systemic glucocorticoids within 3 months prior to screening, serious infection or recent major surgery and transplantation; 13. History of joint pain after use of DPP-4 inhibitors; 14. Investigational product (placebo) treatment compliance rate = 400 mL, excluding female menstrual blood volume), receiving blood transfusion or using blood products within 3 months before screening; 20. Men who drink more than 21 units of alcohol per week and women who drink more than 14 units (1 unit of alcohol ˜ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK;PD;HbA1c;Fasting blood glucose;2-hour postprandial blood glucose; | — |
Countries
China
Contacts
Public ContactWenying Yang
Outcome results
None listed