Type 2 Diabetes
Conditions
Interventions
metformin is administrated and dosage will be increased appropriately to reach the target HbA1c level (6.5% JDS).
Sitagliptin is administrated and dosage will be increased appropriately to reach the t
Sponsors
Osaka City University Graduate School of Medicine, Metabolism, Endocrinology, and Molecular Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with type 2 diabetes under life style intervention or mellitus taking an oral hypoglycemic agent except metformin, pioglitazone, DPP-4 inhibitor, GLP -1 analog preparation. 2)HbA1c >=6.5%, <=10.0%(JDS). 3)Age >=20 years, <75 years 4)Inpatient or outpatient. 5)Informed consent obtained
Exclusion criteria
Exclusion criteria: 1)The use of oral hypoglycemic agents, insulin preparations adrenocorticosteroid within 12 weeks prior to the start of observation period. 2)Patients with severe ketosis, diabetic coma, or with precoma 3)Patients with severe infections, before or after operation, or with serious trauma. 4)AST, ALT <=2.5 x Upper limit of facility reference at most recent of the registration, or patients with hepatic cirrhosis. 5)Patients with renal impairment.(Diabetic nephropathy staging >=stage3B before registration.) 6)Serve cardiovascular or pulmonary disorders, including shock, heart failure, myocardial infarction, lung infarction etc., or other conditions that are apt to cause hypoxemia. 7) Patients suffering from malnutrition, inanition, debility, pituitary gland malfunction, or adrenal gland dysfunction. 8)History of lactic acidosis. 9)Patients with a malignant tumor treated now. 10)History of hypersensitivity to biguanide oral hypoglycemic agent or DPP-4 inhibitor. 11)Pregnant women or women suspected of being pregnant. 12)Other patients determined to be inappropriate by physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| esRAGE level of the plasma at 24 weeks after administration of metformin or sitagliptin. | — |
Secondary
| Measure | Time frame |
|---|---|
| sRAGE level of the plasma, pentosidine, HbA1C, FGP, BMI, TC, HDL, LDL, TG, ACR(Albumen Creatinine Ratio) 24 weeks after administration of metformin or sitagliptin. | — |
Countries
Japan
Contacts
Public ContactShinya Fukumoto
Osaka City University Graduate School of Medicine Metabolism, Endocrinology, and Molecular Medicine
Outcome results
None listed