PMID- 28294488 OWN - NLM STAT- MEDLINE DCOM- 20180619 LR - 20221207 IS - 1463-1326 (Electronic) IS - 1462-8902 (Print) IS - 1462-8902 (Linking) VI - 19 IP - 8 DP - 2017 Aug TI - Efficacy and safety of sitagliptin as compared with glimepiride in Japanese patients with type 2 diabetes mellitus aged >/= 60 years (START-J trial). PG - 1188-1192 LID - 10.1111/dom.12933 [doi] AB - The aim of this study was to evaluate the efficacy and safety of sitagliptin administered to elderly patients with type 2 diabetes mellitus (T2DM) for 1 year as compared with glimepiride. Patients aged >/=60 years with T2DM and inadequately controlled blood glucose were randomly assigned to sitagliptin 50 mg once daily or glimepiride 0.5 mg once daily for 52 weeks. The primary efficacy endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 52. Secondary efficacy endpoints included self-monitored blood glucose and weight. Safety endpoints were adverse events including hypoglycaemia. Administration of sitagliptin or glimepiride to elderly patients with T2DM resulted in a significant decrease in HbA1c change from baseline. At 52 weeks, the least squares mean difference between the treatments was 0.11% (95% confidence interval [CI] -0.02 to 0.24; P = .087) (1.2 mmol/mol [-0.2 to 2.6]). The upper limit of the CI was below the predefined non-inferiority margin (0.3% [3.3 mmol/mol]), demonstrating non-inferiority of sitagliptin to glimepiride for the primary endpoint. Sitagliptin resulted in a significantly lower incidence rate of non-serious hypoglycaemia than glimepiride during the 52 weeks (4.7% vs 16.1%; P = .002); thus, sitagliptin is a useful therapeutic option for elderly patients with T2DM. CI - (c) 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. FAU - Terauchi, Yasuo AU - Terauchi Y AD - Japan Association for Diabetes Education and Care, Tokyo, Japan. AD - Department of Endocrinology and Metabolism, Yokohama City University Graduate School of Medicine, Yokohama, Japan. FAU - Yamada, Yuichiro AU - Yamada Y AD - Japan Association for Diabetes Education and Care, Tokyo, Japan. AD - Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University School of Medicine, Akita, Japan. FAU - Ishida, Hitoshi AU - Ishida H AD - Japan Association for Diabetes Education and Care, Tokyo, Japan. AD - Third Department of Internal Medicine, Division of Diabetes, Endocrinology and Metabolism, Kyorin University School of Medicine, Mitaka, Japan. FAU - Ohsugi, Mitsuru AU - Ohsugi M AD - Japan Association for Diabetes Education and Care, Tokyo, Japan. AD - Diabetes and Metabolism Information Centre, Diabetes Research Centre, Research Institute, National Centre for Global Health and Medicine, Tokyo, Japan. FAU - Kitaoka, Masafumi AU - Kitaoka M AD - Japan Association for Diabetes Education and Care, Tokyo, Japan. AD - IMS Miyoshi General Hospital, Miyoshi, Japan. FAU - Satoh, Jo AU - Satoh J AD - Japan Association for Diabetes Education and Care, Tokyo, Japan. AD - Tohoku Medical and Pharmaceutical University Wakabayashi Hospital, Sendai, Japan. FAU - Yabe, Daisuke AU - Yabe D AD - Japan Association for Diabetes Education and Care, Tokyo, Japan. AD - Yutaka Seino Distinguished Centre for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan. AD - Department of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan. AD - Division of Molecular and Metabolic Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. FAU - Shihara, Nobuyuki AU - Shihara N AUID- ORCID: 0000-0002-9422-5360 AD - Japan Association for Diabetes Education and Care, Tokyo, Japan. FAU - Seino, Yutaka AU - Seino Y AD - Japan Association for Diabetes Education and Care, Tokyo, Japan. AD - Yutaka Seino Distinguished Centre for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan. AD - Centre for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan. LA - eng SI - ClinicalTrials.gov/NCT01183104 PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20170412 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 (Incretins) RN - 0 (Sulfonylurea Compounds) RN - 0 (hemoglobin A1c protein, human) RN - 6KY687524K (glimepiride) RN - TS63EW8X6F (Sitagliptin Phosphate) SB - IM MH - Activities of Daily Living MH - Aged MH - Aged, 80 and over MH - *Aging/ethnology MH - Blood Glucose Self-Monitoring MH - Diabetes Mellitus, Type 2/blood/*drug therapy/ethnology MH - Dipeptidyl-Peptidase IV Inhibitors/adverse effects/therapeutic use MH - Equivalence Trials as Topic MH - Glycated Hemoglobin/analysis MH - Humans MH - Hyperglycemia/epidemiology/physiopathology/*prevention & control MH - Hypoglycemia/chemically induced/epidemiology/physiopathology/prevention & control MH - Hypoglycemic Agents/adverse effects/*therapeutic use MH - Incidence MH - Incretins/adverse effects/*therapeutic use MH - Japan/epidemiology MH - Middle Aged MH - Reproducibility of Results MH - Severity of Illness Index MH - Sitagliptin Phosphate/adverse effects/*therapeutic use MH - Sulfonylurea Compounds/adverse effects/*therapeutic use MH - Weight Loss/drug effects PMC - PMC5573934 OTO - NOTNLM OT - DPP-4 inhibitor OT - clinical trial OT - randomized trial OT - sitagliptin OT - sulphonylureas EDAT- 2017/03/16 06:00 MHDA- 2018/06/20 06:00 PMCR- 2017/08/29 CRDT- 2017/03/16 06:00 PHST- 2016/12/28 00:00 [received] PHST- 2017/03/03 00:00 [revised] PHST- 2017/03/06 00:00 [accepted] PHST- 2017/03/16 06:00 [pubmed] PHST- 2018/06/20 06:00 [medline] PHST- 2017/03/16 06:00 [entrez] PHST- 2017/08/29 00:00 [pmc-release] AID - DOM12933 [pii] AID - 10.1111/dom.12933 [doi] PST - ppublish SO - Diabetes Obes Metab. 2017 Aug;19(8):1188-1192. doi: 10.1111/dom.12933. Epub 2017 Apr 12.