type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)type 2 diabetes who have inadequate glycemic control (HbA1c more than 7%) under medical treatment by dieting and exercise cure and/or drug treatment 2)patients who have no history of cardiovascular disease 3)no treatment or treatment with stable doses of antihypertensive agents for at least 3 months prior to randomization. 4)no treatment or treatment with stable doses of antiplatelet agents for at least 3 months prior to randomization. 5)patients who give a written informed.
Exclusion criteria
Exclusion criteria: 1)type 1 diabetes 2)patients with severe renal dysfunction (eGFR < 30 ml/min/1.73m2) 3)patients with liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges) 4)a pregnant woman and/or a woman under breast-feeding 5)patients who have diabetic proliferative retinopathy. 6)patients who have an anamnesis of hypersensitivity to the ingredient of a trial drugs. 7)patients who reciving GLP-1 recepter agonist. 8)patients who thought to be inappropriate to enter this study for some medical reasons by physician's judgments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c (after 6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin, hematocrit, erythropoietin, AST, ALT, gamma GTP, Cre, eGFR, Na, K, Cl, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride, RLP cholesterol, uric acid, BNP, cystatin C, CRP, hydroxybutyric acid, glucagon, KIM1, LFABP, 25(OD)VitD, leptin , IL-6, ApoB48, Treg, Th17, HMW adiponectin, FGF21, folic acid ,urinary glucose, urinary protein, urinary keton, urinary albumin, visceral fat area, BMI, blood-pressure, pulse, rate, DPP4 concentration and DPP4 activity. (3 months and 6 months after treatment) | — |
Countries
Japan
Contacts
Dokkyo Medical University Department of Endocrinology and Metabolism