Lu C.-H.Min K.W.LEE-MING CHUANGKokubo S.Yoshida S.Cha B.-S.2020-06-012020-06-0120162040-1116https://www.scopus.com/inward/record.uri?eid=2-s2.0-84949667903&doi=10.1111%2fjdi.12422&partnerID=40&md5=db1e29ce98a6b7fda92ed0a8fb4152dfhttps://scholars.lib.ntu.edu.tw/handle/123456789/495694Aims/Introduction: To determine the efficacy and safety of ipragliflozin in combination with metformin in Asian patients with type 2 diabetes mellitus. Materials and Methods: This phase 3, multicenter, placebo-controlled, double-blind, parallel-group study was carried out at 18 sites in Korea and 12 sites in Taiwan. After an 8-week washout period for patients using drugs other than metformin and a 2-week run-in period, patients were randomized to either 50 mg ipragliflozin or a placebo for 24 weeks while continuing metformin. Efficacy outcomes included the changes in hemoglobin A1c, fasting plasma glucose (FPG) and bodyweight from baseline to the end of treatment (with last observation carried forward). Safety outcomes included treatment-emergent adverse events. Results: Between November 2011 and January 2013, 171 patients were randomized to and administered ipragliflozin (n = 87) or a placebo (n = 83). The mean changes (standard deviation) in hemoglobin A1c were -0.94% (0.75%) and -0.47% (0.81%) in the ipragliflozin and placebo groups, respectively (between-group difference -0.46%, P < 0.001). The changes in fasting plasma glucose and bodyweight were also significantly greater in the ipragliflozin group, with between-group differences of -14.1 mg/dL and -1.24 kg, respectively (both P < 0.001). The most common treatment-emergent adverse events (ipragliflozin vs placebo) were upper respiratory tract infection (9.2% vs 12.0%) and urinary tract infection (6.9% vs 2.4%). Conclusions: These results show that ipragliflozin is effective and well tolerated when used in combination with metformin in Asian patients with type 2 diabetes mellitus. ? 2016 Asian Association for the Study of Diabetes and John Wiley & Sons Australia, Ltd.[SDGs]SDG3alanine aminotransferase; bilirubin glucuronide; creatinine; fatty acid; glucose; hemoglobin; hemoglobin A1c; high density lipoprotein cholesterol; ipragliflozin; low density lipoprotein cholesterol; magnesium; metformin; nitrogen; phosphorus; placebo; potassium; triacylglycerol; urea; glucoside; ipragliflozin; metformin; thiophene derivative; acute pyelonephritis; adult; Article; Asian; colon polyp; compression fracture; concussion; constipation; controlled study; contusion; diastolic blood pressure; dizziness; double blind procedure; drug efficacy; drug safety; drug tolerability; drug withdrawal; dysuria; erythrocyte count; female; genital tract infection; glomerulus filtration rate; glycemic control; hematocrit; human; hydronephrosis; hypertransaminasemia; hypoglycemia; Korean (people); major clinical study; male; multicenter study; nocturia; non insulin dependent diabetes mellitus; osteoarthritis; parallel design; phase 3 clinical trial; pollakisuria; polyuria; priority journal; proteinuria; randomized controlled trial; rhinopharyngitis; side effect; spine disease; synovial cyst; systolic blood pressure; Taiwanese; upper respiratory tract infection; urea nitrogen blood level; ureter obstruction; urinary tract infection; urine osmolality; waist circumference; weight reduction; adverse effects; Asian continental ancestry group; clinical trial; combination drug therapy; Diabetes Mellitus, Type 2; treatment outcome; Asian Continental Ancestry Group; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Therapy, Combination; Female; Glucosides; Humans; Male; Metformin; Thiophenes; Treatment Outcomejournal article10.1111/jdi.12422273307232-s2.0-84949667903