PMID- 26277887 OWN - NLM STAT- MEDLINE DCOM- 20160815 LR - 20221207 IS - 1463-1326 (Electronic) IS - 1462-8902 (Linking) VI - 17 IP - 12 DP - 2015 Dec TI - Efficacy and safety of pioglitazone added to alogliptin in Japanese patients with type 2 diabetes mellitus: a multicentre, randomized, double-blind, parallel-group, comparative study. PG - 1198-201 LID - 10.1111/dom.12555 [doi] AB - A phase IV, multicentre, randomized, double-blind, parallel-group, comparative study was conducted in Japanese subjects with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control, despite treatment with alogliptin in addition to diet and/or exercise therapy. Subjects with glycated haemoglobin (HbA1c) concentrations of 6.9-10.5% were randomized to receive 16 weeks' double-blind treatment with pioglitazone 15 mg, 30 mg once daily or placebo added to alogliptin 25 mg once daily. The primary endpoint was the change in HbA1c from baseline at the end of treatment period (week 16). Both pioglitazone 15 and 30 mg combination therapy resulted in a significantly greater reduction in HbA1c than alogliptin monotherapy [-0.80 and -0.90% vs 0.00% (the least squares mean using analysis of covariance model); p < 0.0001, respectively]. The overall incidence rates of treatment-emergent adverse events were similar among the treatment groups. Pioglitazone/alogliptin combination therapy was effective and generally well tolerated in Japanese subjects with T2DM and is considered to be useful in clinical settings. CI - (c) 2015 John Wiley & Sons Ltd. FAU - Kaku, K AU - Kaku K AD - Department of Medicine, Kawasaki Medical School, Okayama, Japan. FAU - Katou, M AU - Katou M AD - Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan. FAU - Igeta, M AU - Igeta M AD - Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan. FAU - Ohira, T AU - Ohira T AD - Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan. FAU - Sano, H AU - Sano H AD - Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan. LA - eng PT - Clinical Trial, Phase IV PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20151023 PL - England TA - Diabetes Obes Metab JT - Diabetes, obesity & metabolism JID - 100883645 RN - 0 (Dipeptidyl-Peptidase IV Inhibitors) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Piperidines) RN - 0 (Thiazolidinediones) RN - 0 (hemoglobin A1c protein, human) RN - 56HH86ZVCT (Uracil) RN - JHC049LO86 (alogliptin) RN - X4OV71U42S (Pioglitazone) SB - IM MH - Combined Modality Therapy/adverse effects MH - Diabetes Mellitus, Type 2/blood/diet therapy/*drug therapy/therapy MH - Diet, Diabetic MH - Dipeptidyl-Peptidase IV Inhibitors/adverse effects/*therapeutic use MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Drug Resistance MH - Drug Therapy, Combination/adverse effects MH - Exercise MH - Glycated Hemoglobin/analysis MH - Humans MH - Hyperglycemia/*prevention & control MH - Hypoglycemic Agents/administration & dosage/adverse effects/*therapeutic use MH - Japan MH - Pioglitazone MH - Piperidines/adverse effects/*therapeutic use MH - Thiazolidinediones/administration & dosage/adverse effects/*therapeutic use MH - Uracil/adverse effects/*analogs & derivatives/therapeutic use OTO - NOTNLM OT - alogliptin OT - combination therapy OT - glycaemic control OT - pioglitazone OT - type 2 diabetes mellitus EDAT- 2015/08/19 06:00 MHDA- 2016/08/16 06:00 CRDT- 2015/08/18 06:00 PHST- 2015/05/20 00:00 [received] PHST- 2015/06/07 00:00 [revised] PHST- 2015/08/13 00:00 [accepted] PHST- 2015/08/18 06:00 [entrez] PHST- 2015/08/19 06:00 [pubmed] PHST- 2016/08/16 06:00 [medline] AID - 10.1111/dom.12555 [doi] PST - ppublish SO - Diabetes Obes Metab. 2015 Dec;17(12):1198-201. doi: 10.1111/dom.12555. Epub 2015 Oct 23.