PMID- 27110370 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20160425 LR - 20231111 IS - 2052-4897 (Print) IS - 2052-4897 (Electronic) IS - 2052-4897 (Linking) VI - 4 IP - 1 DP - 2016 TI - Pleiotropic effects of sitagliptin versus voglibose in patients with type 2 diabetes inadequately controlled via diet and/or a single oral antihyperglycemic agent: a multicenter, randomized trial. PG - e000190 LID - 10.1136/bmjdrc-2015-000190 [doi] LID - e000190 AB - PURPOSE: A step-up strategy for diet therapy and/or single oral antihyperglycemic agent (OHA) regimens has not yet been established. The aim of this study was to evaluate hemoglobin A1c (HbA1c) as a primary end point, and the pleiotropic effects on metabolic and cardiovascular parameters as secondary end points, of sitagliptin versus voglibose in patients with type 2 diabetes with inadequate glycemic control while on diet therapy and/or treatment with a single OHA. METHODS: In this multicenter, randomized, open-label, parallel-group trial, a total of 260 patients with inadequately controlled type 2 diabetes (HbA1c levels >6.9%) were randomly assigned to receive either sitagliptin (50 mg, once daily) or voglibose (0.6 mg, thrice daily) for 12 weeks. The primary end point was HbA1c levels. RESULTS: Patients receiving sitagliptin showed a significantly greater decrease in HbA1c levels (-0.78+/-0.69%) compared with those receiving voglibose (-0.30+/-0.78%). Sitagliptin treatment also lowered serum alkaline phosphatase levels and increased serum creatinine, uric acid, cystatin-C and homeostasis model assessment-beta values. Voglibose increased low-density lipoprotein-cholesterol levels and altered serum levels of several fatty acids, and increased Delta-5 desaturase activity. Both drugs increased serum adiponectin. The incidence of adverse events (AEs) was significantly lower in the sitagliptin group, due to the decreased incidence of gastrointestinal AEs. CONCLUSIONS: Sitagliptin shows superior antihyperglycemic effects compared with voglibose as a first-line or second-line therapy. However, both agents possess unique pleiotropic effects that lead to reduced cardiovascular risk in Japanese people with type 2 diabetes. TRIAL REGISTRATION NUMBER: UMIN 000003503. FAU - Matsushima, Yukiko AU - Matsushima Y AD - Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan; Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan; ERA-DM Chapter 1 Study Group, Kanazawa, Ishikawa, Japan. FAU - Takeshita, Yumie AU - Takeshita Y AD - Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan; Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan; ERA-DM Chapter 1 Study Group, Kanazawa, Ishikawa, Japan. FAU - Kita, Yuki AU - Kita Y AD - Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan; ERA-DM Chapter 1 Study Group, Kanazawa, Ishikawa, Japan. FAU - Otoda, Toshiki AU - Otoda T AD - Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan; ERA-DM Chapter 1 Study Group, Kanazawa, Ishikawa, Japan. FAU - Kato, Ken-Ichiro AU - Kato K AD - Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan; ERA-DM Chapter 1 Study Group, Kanazawa, Ishikawa, Japan. FAU - Toyama-Wakakuri, Hitomi AU - Toyama-Wakakuri H AD - Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan; ERA-DM Chapter 1 Study Group, Kanazawa, Ishikawa, Japan. FAU - Akahori, Hiroshi AU - Akahori H AD - ERA-DM Chapter 1 Study Group, Kanazawa, Ishikawa , Japan. FAU - Shimizu, Akiko AU - Shimizu A AD - ERA-DM Chapter 1 Study Group, Kanazawa, Ishikawa , Japan. FAU - Hamaguchi, Erika AU - Hamaguchi E AD - ERA-DM Chapter 1 Study Group, Kanazawa, Ishikawa , Japan. FAU - Nishimura, Yasuyuki AU - Nishimura Y AD - ERA-DM Chapter 1 Study Group, Kanazawa, Ishikawa , Japan. FAU - Kanamori, Takehiro AU - Kanamori T AD - Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan; ERA-DM Chapter 1 Study Group, Kanazawa, Ishikawa, Japan. FAU - Kaneko, Shuichi AU - Kaneko S AD - Department of Disease Control and Homeostasis , Kanazawa University Graduate School of Medical Sciences , Kanazawa, Ishikawa , Japan. FAU - Takamura, Toshinari AU - Takamura T AD - Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan; Department of Disease Control and Homeostasis, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, Japan; ERA-DM Chapter 1 Study Group, Kanazawa, Ishikawa, Japan. LA - eng PT - Journal Article DEP - 20160419 PL - England TA - BMJ Open Diabetes Res Care JT - BMJ open diabetes research & care JID - 101641391 PMC - PMC4838664 OTO - NOTNLM OT - A1C OT - Drug Therapy OT - Fatty Acid Desaturase(s) EDAT- 2016/04/26 06:00 MHDA- 2016/04/26 06:01 PMCR- 2016/04/19 CRDT- 2016/04/26 06:00 PHST- 2015/12/24 00:00 [received] PHST- 2016/02/04 00:00 [revised] PHST- 2016/02/15 00:00 [accepted] PHST- 2016/04/26 06:00 [entrez] PHST- 2016/04/26 06:00 [pubmed] PHST- 2016/04/26 06:01 [medline] PHST- 2016/04/19 00:00 [pmc-release] AID - bmjdrc-2015-000190 [pii] AID - 10.1136/bmjdrc-2015-000190 [doi] PST - epublish SO - BMJ Open Diabetes Res Care. 2016 Apr 19;4(1):e000190. doi: 10.1136/bmjdrc-2015-000190. eCollection 2016.