Effect of Metformin on the esRAGE levels in type 2 diabetic patients: the Metformin Sitagliptin Randomized Trial

Not Applicable

• Conditions: Type 2 Diabetes

• Registration Number: JPRN-UMIN000005253
• Lead Sponsor: Osaka City University Graduate School of Medicine, Metabolism, Endocrinology, and Molecular Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-01
• Study Completion: 2014-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
esRAGE level of the plasma at 24 weeks after administration of metformin or sitagliptin.

Secondary Outcome Measures

Name	Time	Method
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.