title: 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).
abstract: OBJECTIVE
  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.
authors.affiliation: 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.
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Fujitani
authors.affiliation: Department of Endocrinology, Metabolism and Nephrology, Kochi Medical School, Kochi University, Nankoku-shi, Kochi, Japan.
authors.forename: Shimpei
authors.initials: S
authors.lastname: Fujimoto
authors.affiliation: Takahashi Kiyohito Clinic, Hakodate, Hokkaido, Japan.
authors.forename: Kiyohito
authors.initials: K
authors.lastname: Takahashi
authors.affiliation: Department of Nephrology, Hypertension, Diabetology, Endocrinology, and Metabolism, Fukushima Medical University, Fukushima, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Satoh
authors.affiliation: Division of Diabetes, Metabolism, and Endocrinology, Department of Medicine, Toho University School of Medicine, Tokyo, Japan.
authors.forename: Takahisa
authors.initials: T
authors.lastname: Hirose
authors.affiliation: Japanese Red Cross Medical Center, Tokyo, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Hiyoshi
authors.affiliation: Department of Insured Medical Care Management, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.
authors.forename: Masumi
authors.initials: M
authors.lastname: Ai
authors.affiliation: First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu-shi, Japan.
authors.forename: Yosuke
authors.initials: Y
authors.lastname: Okada
authors.affiliation: Department of Clinical Trial and Clinical Epidemiology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Gosho
authors.affiliation: Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan; Center for Molecular Diabetology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Tomoya
authors.initials: T
authors.lastname: Mita
authors.affiliation: 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.
authors.forename: Hirotaka
authors.initials: H
authors.lastname: Watada
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D007294:Inositol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D007564:Japan; D000069476:Linagliptin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D019518:Postprandial Period; D012189:Retrospective Studies; D013997:Time Factors; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D000069476:Linagliptin; D007294:Inositol; C102817:voglibose
keywords: Alpha-glucosidase inhibitor; DPP4 inhibitor; Postprandial hyperglycemia; Type 2 diabetes mellitus