T2DM
Conditions
Interventions
Treatment:Previous hypoglycemic treatment combined with oral administration of chiglitazar 48mg once a day
Placebo:Previous hypoglycemic treatment combined with placebo
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meet the WHO Diagnostic Criteria for Type 2 Diabetes (published in 1999); 2. Age >= 18, = 22.5 kg/m^2, 7.5%; 20% of baseline value for >= 12 weeks before randomization) of insulin >= 0.6 IU/kg/day and/or 40 IU/day, stable treatment >= 3 months; 6. With or without other oral antidiabetic drugs >= 8 weeks; 7. Willing to be assigned to any treatment arm and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes or special type diabetes; 2. A history of using Chiglitazar, Glucagon-like peptide-1 receptor agonist (GLP-1RA) or Thiazolidinedione (TZD) within 3 months; 3. Stable treatment of fibrates or other lipid-lowering drugs (not fibrates) = 180/110 mmHg); 5. Plasma triglyceride (TG) > 500 mg/dL (5.65 mmol/L); 6. Edema of lower extremities or anasarca; 7. Have experienced three or more severe hypoglycemic episodes and/or unconscious hypoglycemia in the 6 months before screening; 8. Experience uncontrolled hyperglycemia within 3 months, fasting plasma glucose > 13.9 mmol/L; 9. Dual energy X-ray diagnosed as osteoporosis, or a history of brittle fractures, or any other known metabolic bone disease; 10. History of diabetic ketoacidosis, diabetic hyperglycemic hyperosmolar syndrome, lactic acidosis; 11. Experienced acute myocardial infarction, unstable angina, cerebral infarction, and cerebral hemorrhage within 6 months; 12. Systemic hormone application and malignant tumor patients; 13. New York Heart Association (NYHA) Class III or IV; 14. Significant liver and kidney dysfunction and systemic diseases (Hepatic diseases: aspartate aminotransferase and/or alanine aminotransferase > 2.5 fold and/or total bilirubin > 1.5 fold of the upper limit of the normal range; Renal dysfunction is defined as moderate to severe renal insufficiency [eGFR < 60 ml/(min x 1.73 m^2)]); 15. Blood routine test: White blood cell (WBC) count per unit volume in peripheral blood < 3.5 x 10^9/L or hemoglobin concentration (HGB) below normal standards for the same age, gender, and region (male HGB < 130 g/L, female HGB < 115 g/L); 16. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method throughout the trial; 17. Participating or had participated in clinical trials of other drugs or medical devices in the 3 months before screening; 18. Any condition that make investigator consider the subject is not suitable to participate the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| daily dosage of insulin; | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c;Fasting plasma glucose, FPG;Postprandial plasma glucose, PPG;fasting C-peptide, FCP;TC,LDL-C,HDL-C,TG;Percentage of participants reducing daily dosage of insulin;Percentage of participants with HbA1c <7% and no hypoglycemia; | — |
Countries
China
Contacts
Public ContactYao Jun
Peking University First Hospital
Outcome results
None listed