Diabetes
Conditions
Interventions
Experimental Group:Metformin + Sitagliptin (Jenoda I) group
Control group:Metformin + Pioglitazone
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Patients with type 2 diabetes mellitus who are not treated with metformin alone (=1000mg/day, =4 weeks); (2) Aged 18 to 65 years, body mass index 20-35 kg/m2; (3) Glycated hemoglobin (HbA1c) 7.5-10.0%; (4) Volunteer to participate in this clinical study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with severe liver and kidney damage (ALT and / or AST more than 2.5 times the upper limit of normal, glomerular filtration rate <45ml / min); (2) Cardiac dysfunction (New York heart function classification reached grade III or above), acute coronary syndrome or acute myocardial infarction occurred in the past 3 months; (3) Blood pressure: SBP= 150mmHg and/or DBP= 90mmHg; (4) Current endocrine system diseases such as hyperthyroidism and hypercortisolism; (5) Any contraindications to pioglitazone or sitagliptin, or patients who are allergic to the test drug; (6) Frequent hypoglycemia; (7) Other thiazolidinediones are being used; (8) History of osteoporosis, history of non-violent fractures, etc.; (9) Combine the use of drugs that affect glucose metabolism, such as glucocorticoids; (10) Tumor patients, especially those with bladder tumors, and/or with a family history of bladder tumors, and/or a history of long-term hematuria; (11) Pregnancy or breastfeeding; (12) Women of childbearing age who do not use appropriate contraceptive measures; (13) Those who have participated in other drug clinical trials within three months; (14) Patients considered by the investigator to be unfit for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduced level of glycated hemoglobin (HbA1c);Fasting insulin level, HOMA-IR index, proinsulin/insulin ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose, 2h blood glucose reduction after standard meal;Blood lipid levels: triglycerides, cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol;Inflammatory index: IL-6, adiponectin;Fatty liver (MRI);Intra-abdominal fat (CT);Liver enzyme index: ALT, GTT;Blood pressure level;Urinary albumin/creatinine; | — |
Countries
China
Contacts
Public ContactNanwei Tong
Outcome results
None listed