title: Efficacy, safety and dose-response relationship of teneligliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus.
abstract: OBJECTIVE
  To assess the efficacy, safety and dose-response relationship of once-daily teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.
  
  
  METHODS
  In this randomized, double-blind, placebo-controlled, parallel-group study, patients (n = 324) were randomized to receive teneligliptin 10, 20 or 40 mg, or placebo, once daily before breakfast for 12 weeks. The primary endpoint was the change in haemoglobin (Hb)A1c from baseline to week 12.
  
  
  RESULTS
  All teneligliptin-treated groups showed significantly greater reductions in HbA1c and fasting plasma glucose (FPG) than did the placebo group. The differences between the teneligliptin 10, 20 or 40 mg groups and the placebo group for the change in HbA1c were -0.9 [least-squares (LS) mean; 95% confidence interval: -1.0, -0.7], -0.9 (-1.1, -0.7) and -1.0 (-1.2, -0.9)%, respectively (all, p < 0.001). The respective LS means for FPG were -17.8 (-23.4, -12.1), -16.9 (-22.6, -11.2) and -20.0 (-25.7, -14.3) mg/dl (all, p < 0.001). There were no significant differences in HbA1c among the three doses of teneligliptin. The incidence of adverse events and adverse drug reactions was similar in each group. The incidence of hypoglycaemia was not significantly different among the four groups.
  
  
  CONCLUSIONS
  Treatment with teneligliptin for 12 weeks provided significant and clinically meaningful reductions in HbA1c and FPG across the dose range studied and was generally well tolerated in Japanese patients with T2DM.
authors: Department of Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors: T
authors: T
authors: Kadowaki
authors: K
authors: K
authors: Kondo
mesh_terms: D000328:Adult; D000368:Aged; D019540:Area Under Curve; D044466:Asian People / Q000706:statistics & numerical data; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005215:Fasting; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011720:Pyrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D053778:Thiazolidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D011720:Pyrazoles; D053778:Thiazolidines; C579035:3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine; C517652:hemoglobin A1c protein, human
keywords: DPP-4 inhibitor; HbA1c; teneligliptin; type 2 diabetes mellitus