PMID- 24919820 OWN - NLM STAT- MEDLINE DCOM- 20150924 LR - 20221207 IS - 1463-1326 (Electronic) IS - 1462-8902 (Print) IS - 1462-8902 (Linking) VI - 17 IP - 3 DP - 2015 Mar TI - Ipragliflozin in combination with metformin for the treatment of Japanese patients with type 2 diabetes: ILLUMINATE, a randomized, double-blind, placebo-controlled study. PG - 304-8 LID - 10.1111/dom.12331 [doi] AB - 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. CI - (c) 2014 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. FAU - Kashiwagi, A AU - Kashiwagi A AD - Department of Medicine, Shiga University of Medical Science, Shiga, Japan. FAU - Kazuta, K AU - Kazuta K FAU - Goto, K AU - Goto K FAU - Yoshida, S AU - Yoshida S FAU - Ueyama, E AU - Ueyama E FAU - Utsuno, A AU - Utsuno A LA - eng PT - Letter PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20140731 PL - England TA - Diabetes Obes Metab JT - Diabetes, obesity & metabolism JID - 100883645 RN - 0 (Blood Glucose) RN - 0 (Glucosides) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Placebos) RN - 0 (Thiophenes) RN - 0 (hemoglobin A1c protein, human) RN - 3N2N8OOR7X (ipragliflozin) RN - 9100L32L2N (Metformin) SB - IM MH - Aged MH - Asian People MH - Blood Glucose/drug effects MH - Body Weight/drug effects MH - Diabetes Mellitus, Type 2/*drug therapy MH - Double-Blind Method MH - Drug Therapy, Combination/methods MH - Female MH - Glucosides/*therapeutic use MH - Glycated Hemoglobin/drug effects MH - Humans MH - Hypoglycemic Agents/*therapeutic use MH - Male MH - Metformin/*therapeutic use MH - Middle Aged MH - Placebos MH - Thiophenes/*therapeutic use PMC - PMC4342773 OTO - NOTNLM OT - Japanese OT - SGLT2 OT - ipragliflozin OT - metformin OT - randomized controlled trial OT - type 2 diabetes EDAT- 2014/06/13 06:00 MHDA- 2015/09/25 06:00 PMCR- 2015/02/27 CRDT- 2014/06/13 06:00 PHST- 2014/02/10 00:00 [received] PHST- 2014/05/13 00:00 [revised] PHST- 2014/06/09 00:00 [accepted] PHST- 2014/06/13 06:00 [entrez] PHST- 2014/06/13 06:00 [pubmed] PHST- 2015/09/25 06:00 [medline] PHST- 2015/02/27 00:00 [pmc-release] AID - 10.1111/dom.12331 [doi] PST - ppublish SO - Diabetes Obes Metab. 2015 Mar;17(3):304-8. doi: 10.1111/dom.12331. Epub 2014 Jul 31.