PMID- 27710821 OWN - NLM STAT- MEDLINE DCOM- 20170117 LR - 20181202 IS - 1872-8227 (Electronic) IS - 0168-8227 (Linking) VI - 121 DP - 2016 Nov TI - Effects of linagliptin monotherapy compared with voglibose on postprandial blood glucose responses in Japanese patients with type 2 diabetes: Linagliptin Study of Effects on Postprandial blood glucose (L-STEP). PG - 146-156 LID - S0168-8227(16)30605-2 [pii] LID - 10.1016/j.diabres.2016.09.014 [doi] AB - AIMS: To compare the efficacy on glycemic parameters between a 12-week administration of once-daily linagliptin and thrice-daily voglibose in Japanese patients with type 2 diabetes. METHODS: In a multi-center, randomized, parallel-group study, 382 patients with diabetes were randomized to the linagliptin group (n=192) or the voglibose group (n=190). A meal tolerance test was performed at weeks 0 and 12. Primary outcomes were the change from baseline to week 12 in serum glucose levels at 2h during the meal tolerance test, HbA1c levels, and serum fasting glucose levels, which were compared between the 2 groups. RESULTS: Whereas changes in serum glucose levels at 2h during the meal tolerance test did not differ between the groups, the mean change in HbA1c levels from baseline to week 12 in the linagliptin group (-0.5+/-0.5% [-5.1+/-5.4mmol/mol]) was significantly larger than in the voglibose group (-0.2+/-0.5% [-2.7+/-5.4mmol/mol]). In addition, there was significant difference in changes in serum fasting glucose levels (-0.51+/-0.95mmol/L in the linagliptin group vs. -0.18+/-0.92mmol/L in the voglibose group, P<0.001). The incidences of hypoglycemia, serious adverse events (AEs), and discontinuations due to AEs were low and similar in both groups. However, gastrointestinal AEs were significantly lower in the linagliptin group (1.05% vs. 5.85%; P=0.01). CONCLUSIONS: These data suggested that linagliptin monotherapy had a stronger glucose-lowering effect than voglibose monotherapy with respect to HbA1c and serum fasting glucose levels, but not serum glucose levels 2h after the start of the meal tolerance test. CI - Copyright (c) 2016 Elsevier Ireland Ltd. All rights reserved. FAU - Fujitani, Yoshio AU - Fujitani Y AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan; Center for Therapeutic Innovations in Diabetes, Juntendo University Graduate School of Medicine, Tokyo, Japan. FAU - Fujimoto, Shimpei AU - Fujimoto S AD - Department of Endocrinology, Metabolism and Nephrology, Kochi Medical School, Kochi University, Nankoku-shi, Kochi, Japan. FAU - Takahashi, Kiyohito AU - Takahashi K AD - Takahashi Kiyohito Clinic, Hakodate, Hokkaido, Japan. FAU - Satoh, Hiroaki AU - Satoh H AD - Department of Nephrology, Hypertension, Diabetology, Endocrinology, and Metabolism, Fukushima Medical University, Fukushima, Japan. FAU - Hirose, Takahisa AU - Hirose T AD - Division of Diabetes, Metabolism, and Endocrinology, Department of Medicine, Toho University School of Medicine, Tokyo, Japan. FAU - Hiyoshi, Toru AU - Hiyoshi T AD - Japanese Red Cross Medical Center, Tokyo, Japan. FAU - Ai, Masumi AU - Ai M AD - Department of Insured Medical Care Management, Tokyo Medical and Dental University (TMDU), Tokyo, Japan. FAU - Okada, Yosuke AU - Okada Y AD - First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu-shi, Japan. FAU - Gosho, Masahiko AU - Gosho M AD - Department of Clinical Trial and Clinical Epidemiology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan. FAU - Mita, Tomoya AU - Mita T AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan; Center for Molecular Diabetology, Juntendo University Graduate School of Medicine, Tokyo, Japan. FAU - Watada, Hirotaka AU - Watada H AD - Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan; Center for Beta-Cell Biology and Regeneration, Juntendo University Graduate School of Medicine, Tokyo, Japan; Center for Therapeutic Innovations in Diabetes, Juntendo University Graduate School of Medicine, Tokyo, Japan; Center for Molecular Diabetology, Juntendo University Graduate School of Medicine, Tokyo, Japan; Sportology Center, Juntendo University Graduate School of Medicine, Tokyo, Japan. Electronic address: hwatada@juntendo.ac.jp. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20160922 PL - Ireland TA - Diabetes Res Clin Pract JT - Diabetes research and clinical practice JID - 8508335 RN - 0 (Blood Glucose) RN - 0 (Hypoglycemic Agents) RN - 3X29ZEJ4R2 (Linagliptin) RN - 4L6452S749 (Inositol) RN - S77P977AG8 (voglibose) SB - IM MH - Adult MH - Blood Glucose/*drug effects/metabolism MH - Diabetes Mellitus, Type 2/blood/*drug therapy MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Female MH - Follow-Up Studies MH - Humans MH - Hypoglycemic Agents/administration & dosage MH - Inositol/administration & dosage/*analogs & derivatives MH - Japan MH - Linagliptin/*administration & dosage MH - Male MH - Middle Aged MH - *Postprandial Period MH - Retrospective Studies MH - Time Factors MH - Young Adult OTO - NOTNLM OT - Alpha-glucosidase inhibitor OT - DPP4 inhibitor OT - Postprandial hyperglycemia OT - Type 2 diabetes mellitus EDAT- 2016/10/07 06:00 MHDA- 2017/01/18 06:00 CRDT- 2016/10/07 06:00 PHST- 2016/06/18 00:00 [received] PHST- 2016/08/18 00:00 [revised] PHST- 2016/09/02 00:00 [accepted] PHST- 2016/10/07 06:00 [pubmed] PHST- 2017/01/18 06:00 [medline] PHST- 2016/10/07 06:00 [entrez] AID - S0168-8227(16)30605-2 [pii] AID - 10.1016/j.diabres.2016.09.014 [doi] PST - ppublish SO - Diabetes Res Clin Pract. 2016 Nov;121:146-156. doi: 10.1016/j.diabres.2016.09.014. Epub 2016 Sep 22.