Efficacy and Safety of Chiglitazar Added to Glargine in Patients With Type 2 Diabetes

• 1.In accordance with the World Health Organization (WHO) issued in 1999 diabetes diagnostic criteriaType 2 diabetes mellitus (T2DM);
• 2. Male or female patients ≥18 years old;
• 3, BMI≥18.5 Kg/m2, \< 35 Kg/m2;
• 4, Glycosylated hemoglobin (HbA1C) > 7.5%; ≤10.5%;
• 5, Stable dose (insulin daily therapeutic dose change within ±20%) of glycerine or DI The therapeutic dose of Terterigu or NPH basal insulin is ≥0.25IU/kg/ day/or 20IU/ day；
• 6, Stable basic insulin treatment combined with metformin (metformin dose ≥1000mg/Days or maximum tolerated dose) ≥3 months；
• 7. Voluntarily sign informed consent and agree to be randomly assigned to any experimental group.

Exclusion Criteria:

• 1, Type 1 diabetes or specific type diabetes;
• 2. Fasting blood glucose (FPG) exceeding 13.3 mmol/L (240 mg/dL);
• 3, refractory hypertension [that is, on the basis of improving lifestyle, the application of a reasonable and tolerable sufficient amount of 3 or more antihypertensive drugs (including diuretics) for more than 1 month still does not reach the standard, or take 4 or more antihypertensive drugs to effectively control blood pressure];
• 4. Triglyceride (TG) > 500 mg /dL (5.65 mmol/L);
• 5, is taking or in the last 1 month has taken fibrate drug treatment;
• 6, lower limb edema or general edema;
• 7. Experienced 3 or more episodes of severe hypoglycemia and/or unintentional hypoglycemia in the 6 months prior to screening;
• 8. A definite diagnosis of osteoporosis or any other known bone disease;
• 9. History of diabetic ketoacidosis, diabetic hyperglycemia hyperosmolar syndrome, lactic acidosis and other acute complications of diabetes;
• 10. Severe microvascular complications (proliferative retinopathy; Urinary albumin/creatinine ratio > 300 mg/g; Marked peripheral neuropathy, etc.);
• 11. Large vascular lesions leading to hospital admission within 6 months before inclusion;
• 12, The New York Heart Association (NYHA) defines congestive heart failure as grade III or IV
• 13, significant liver and kidney dysfunction and systemic disease (significant liver dysfunction is defined as AST> 2.5 times the upper limit of normal and/or ALT> 2.5 times the upper limit of normal and/or total bilirubin > 1.5 times the upper limit of normal value; Renal dysfunction was defined as moderate to severe renal insufficiency (eGFR\<60 ml/ (min*1.73m2)).
• 14. Use of other hypoglycemic agents not specified in the inclusion criteria (thiazolidinediones, GLP-1RA, premixed or fast-acting insulin) in the current or 3 months prior to screening, with the exception of short-term treatment with additional insulin (a total of 7 days or less) for complications;
• 15, pregnant or lactating women, women of childbearing age who are unable or unwilling to take adequate contraception;
• 16. Participating in clinical trials of other drugs or medical devices during or within 3 months prior to screening;
• 17. The investigator considers it inappropriate to participate in this clinical trial.