title: Efficacy and safety of sitagliptin as compared with glimepiride in Japanese patients with type 2 diabetes mellitus aged ≥ 60 years (START-J trial).
abstract: 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.
authors.affiliation: Japan Association for Diabetes Education and Care, Tokyo, Japan.|Department of Endocrinology and Metabolism, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Terauchi
authors.affiliation: Japan Association for Diabetes Education and Care, Tokyo, Japan.|Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University School of Medicine, Akita, Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Yamada
authors.affiliation: Japan Association for Diabetes Education and Care, Tokyo, Japan.|Third Department of Internal Medicine, Division of Diabetes, Endocrinology and Metabolism, Kyorin University School of Medicine, Mitaka, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Ishida
authors.affiliation: Japan Association for Diabetes Education and Care, Tokyo, Japan.|Diabetes and Metabolism Information Centre, Diabetes Research Centre, Research Institute, National Centre for Global Health and Medicine, Tokyo, Japan.
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Ohsugi
authors.affiliation: Japan Association for Diabetes Education and Care, Tokyo, Japan.|IMS Miyoshi General Hospital, Miyoshi, Japan.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Kitaoka
authors.affiliation: Japan Association for Diabetes Education and Care, Tokyo, Japan.|Tohoku Medical and Pharmaceutical University Wakabayashi Hospital, Sendai, Japan.
authors.forename: Jo
authors.initials: J
authors.lastname: Satoh
authors.affiliation: Japan Association for Diabetes Education and Care, Tokyo, Japan.|Yutaka Seino Distinguished Centre for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan.|Department of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan.|Division of Molecular and Metabolic Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Yabe
authors.affiliation: Japan Association for Diabetes Education and Care, Tokyo, Japan.
authors.forename: Nobuyuki
authors.identifier: 0000-0002-9422-5360
authors.initials: N
authors.lastname: Shihara
authors.affiliation: Japan Association for Diabetes Education and Care, Tokyo, Japan.|Yutaka Seino Distinguished Centre for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan.|Centre for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Seino
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging / Q000208:ethnology; D015190:Blood Glucose Self-Monitoring; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000208:ethnology; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D000074099:Equivalence Trials as Topic; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000453:epidemiology / Q000503:physiopathology / Q000517:prevention & control*; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology / Q000503:physiopathology / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D054795:Incretins / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan / Q000453:epidemiology; D008875:Middle Aged; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D000068900:Sitagliptin Phosphate / Q000009:adverse effects / Q000627:therapeutic use*; D013453:Sulfonylurea Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D015431:Weight Loss / Q000187:drug effects
chemical_list: D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D054795:Incretins; D000068900:Sitagliptin Phosphate; D013453:Sulfonylurea Compounds; C517652:hemoglobin A1c protein, human; C057619:glimepiride
keywords: DPP-4 inhibitor; clinical trial; randomized trial; sitagliptin; sulphonylureas