title: Efficacy and safety of the dipeptidyl peptidase-4 inhibitor gemigliptin compared with sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone.
abstract: OBJECTIVE
  This study was designed to assess the efficacy and safety of a dipeptidyl peptidase-4 inhibitor, gemigliptin versus sitagliptin added to metformin in patients with type 2 diabetes.
  
  
  METHODS
  We conducted a double-blind, randomized, active-controlled trial in 425 Asian patients with inadequately controlled type 2 diabetes being treated with metformin alone. Eligible patients were randomized into three groups: 50 mg gemigliptin qd, 25 mg gemigliptin bid or sitagliptin 100 mg qd added to ongoing metformin treatment for 24 weeks. Haemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) were measured periodically, and oral glucose tolerance tests were performed at baseline and 24 weeks after starting the treatment regimen.
  
  
  RESULTS
  Twenty-four weeks later, adding gemigliptin (50 mg/day) to ongoing metformin therapy significantly improved glycaemic control. Reduction in HbA1c caused by 50 mg gemigliptin qd (-0.77% ± 0.8) was non-inferior to that caused by 100 mg sitagliptin qd (-0.8% ± 0.85). Proportion of patients achieving HbA1c <7% while taking 25 mg gemigliptin bid (50%) or 50 mg gemigliptin qd (54.07%) was comparable to the results with 100 mg sitagliptin qd (48.87%). There were significant decreases in FPG, postprandial glucose and AUC0-2 h glucose, as well as increases in GLP-1 and β cell sensitivity to glucose (supported by homeostasis model assessment of β-cell function, postprandial 2-h c-peptide and insulinogenic index) in patients receiving gemigliptin treatment with their metformin therapy. There was no increased risk of adverse effects with this dose of gemigliptin compared with sitagliptin 100 mg qd.
  
  
  CONCLUSIONS
  Addition of gemigliptin 50 mg daily to metformin was shown to be efficacious, well tolerated and non-inferior to sitagliptin in patients with type 2 diabetes mellitus.
authors: Department of Endocrinology and Metabolism, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea. hongsiri@hanmail.net
authors: E J
authors: EJ
authors: Rhee
authors: W Y
authors: WY
authors: Lee
authors: K W
authors: KW
authors: Min
authors: V K
authors: VK
authors: Shivane
authors: A R
authors: AR
authors: Sosale
authors: H C
authors: HC
authors: Jang
authors: C H
authors: CH
authors: Chung
authors: I S
authors: IS
authors: Nam-Goong
authors: J A
authors: JA
authors: Kim
authors: S W
authors: SW
authors: Kim
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D044466:Asian People; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D005215:Fasting; D005260:Female; D052216:Glucagon-Like Peptide 1 / Q000187:drug effects*; D005951:Glucose Tolerance Test; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D010881:Piperidones / Q000627:therapeutic use*; D011719:Pyrazines / Q000627:therapeutic use*; D011743:Pyrimidines / Q000627:therapeutic use*; D056910:Republic of Korea / Q000453:epidemiology; D040242:Risk Reduction Behavior; D000068900:Sitagliptin Phosphate; D016896:Treatment Outcome; D014230:Triazoles / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D052216:Glucagon-Like Peptide 1; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D010881:Piperidones; D011719:Pyrazines; D011743:Pyrimidines; D000068900:Sitagliptin Phosphate; D014230:Triazoles; C534891:LC15-0444; C517652:hemoglobin A1c protein, human