Type 2 diabetes
Conditions
Interventions
Study group:Chiglitazar
Control group:Sagagliptin
Sponsors
Shandong Provincial Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1)Type 2 diabetes patients who meet the diagnostic criteria for diabetes issued by the World Health Organization in 1999; (2)Male or female patients =18, and =70 years of age;history of diabetes mellitus =3 months and =10 years. (3)Patients who have undergone lifestyle interventions such as diet and exercise, and regularly take a stable oral dose (= 1000mg) of metformin for = 8 weeks, but their blood sugar remains uncontrolled; (4)Hemoglobin A1C (HbA1C) =7.0% and =9.5% ; (5) BMI=18.5 Kg/m2, and =35 Kg/m2; (6)Triglyceride =500 mg /dL (5.65 mmol/L);Total cholesterol (TC) =250mg/dl (6.45mmol/L) (If the researcher determines that the temporary elevation is caused by diet or other factors, it can be retested once); (7)Before screening, voluntarily sign an informed consent form and agree to be randomly assigned to any experimental group
Exclusion criteria
Exclusion criteria: (1) Known allergies or previous allergies to the drugs used in this study (2) Participation in a clinical trial of another drug within 3 months prior to the screening period; (3) Taking rosiglitazone or bisiglitazone within 3 months prior to the screening period (4) Refractory hypertension refers to the use of a reasonable and tolerable sufficient amount of three or more antihypertensive drugs on the basis of improving lifestyle, but blood pressure still does not meet the standard for more than one month, or taking four or more antihypertensive drugs can effectively control blood pressure; (5) Triglyceride (TG) >500 mg /dL (5.65 mmol/L); on treatment with a fibrate; (6) History of acute diabetes complications within 3 months prior to the study, or severe chronic complications of diabetes mellitus at the time of screening; (7) Carotid artery stenosis >50% within the previous 6 months, transient ischaemia, cerebrovascular accident, unstable angina pectoris within the 6 months prior to screening; history of myocardial infarction, coronary angioplasty or coronary artery bypass grafting; and cardiac insufficiency (NYHA class III/IV); (8) Pregnant or lactating women, gestational diabetes mellitus or diabetes mellitus combined with pregnancy; (9) Liver disease such as cirrhosis, active hepatitis, or ALT, AST greater than 2.5 times the upper limit of normal; severe renal disease, eGFR < 45 ml/min/1.73 m^2; (10) Any condition or comorbidities that, in the judgement of the investigator, may interfere with the results of the test; (11) Use of medications that may significantly affect glucose metabolism within the first 3 months of screening or expected to use; (12) Oedema; (13) Addiction to alcohol or prohibited drugs; (14) Pregnant or lactating women, women of childbearing age who are unable or unwilling to use adequate contraception; (15) Patients with comorbid psychiatric disorders who are unable or unwilling to co-operate; or any other condition deemed by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| endothelial function;Carotid intima-media thickness; | — |
Secondary
| Measure | Time frame |
|---|---|
| Indicators of arteriosclerosis;Glucose and Lipid Metabolism related indicators; | — |
Countries
China
Contacts
Public ContactZhu lei
Shandong Provincial Third Hospital,
Outcome results
None listed