title: Ipragliflozin in combination with metformin for the treatment of Japanese patients with type 2 diabetes: ILLUMINATE, a randomized, double-blind, placebo-controlled study.
abstract: This multicenter, double-blind, placebo-controlled study examined the efficacy and safety of ipragliflozin, a sodium-glucose co-transporter 2 inhibitor, in combination with metformin in Japanese patients with type 2 diabetes mellitus (T2DM). Patients were randomized in a 2 : 1 ratio to 50 mg ipragliflozin (n = 112) or placebo (n = 56) once daily for 24 weeks, followed by a 28-week open-label extension in which all patients received 50 or 100 mg ipragliflozin, while continuing metformin. The primary outcome was the change in glycated haemoglobin (HbA1c) from baseline to week 24. HbA1c decreased significantly in the ipragliflozin group (-0.87%; adjusted mean difference from placebo: -1.30%; p < 0.001). The overall incidence of treatment-emergent adverse events was similar in both groups, although pollakiuria and constipation were more common in the ipragliflozin group; thus, ipragliflozin significantly improved glycaemic control and reduced body weight without major safety issues in Japanese patients with T2DM.
authors.affiliation: Department of Medicine, Shiga University of Medical Science, Shiga, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Kashiwagi
authors.forename: K
authors.initials: K
authors.lastname: Kazuta
authors.forename: K
authors.initials: K
authors.lastname: Goto
authors.forename: S
authors.initials: S
authors.lastname: Yoshida
authors.forename: E
authors.initials: E
authors.lastname: Ueyama
authors.forename: A
authors.initials: A
authors.lastname: Utsuno
mesh_terms: D000368:Aged; D044466:Asian People; D001786:Blood Glucose / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005960:Glucosides / Q000627:therapeutic use*; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D010919:Placebos; D013876:Thiophenes / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D005960:Glucosides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D010919:Placebos; D013876:Thiophenes; C517652:hemoglobin A1c protein, human; C572941:ipragliflozin
keywords: Japanese; SGLT2; ipragliflozin; metformin; randomized controlled trial; type 2 diabetes