title: Efficacy and safety of adding evogliptin versus sitagliptin for metformin-treated patients with type 2 diabetes: A 24-week randomized, controlled trial with open label extension.
abstract: This trial consisted of a 24-week multicentre, randomized, double-blind, double-dummy, active-controlled study and a 52-week open label extension study to assess the efficacy and safety of evogliptin, a novel dipeptidyl peptidase-4 inhibitor, compared to sitagliptin in patients with type 2 diabetes who have inadequate glycaemic control with metformin alone.
  
  
  
  Adult patients with type 2 diabetes mellitus (N = 222) with HbA1c 6.5% to 11% who were receiving stable doses of metformin (≥1000 mg/d) were randomized 1:1 to add-on evogliptin 5 mg (N = 112) or sitagliptin 100 mg (N = 110) once daily for 24 weeks. The primary efficacy analysis consisted of a comparison of the change from baseline HbA1c at week 24. Non-inferiority was concluded if the upper limit of the 2-sided 95% confidence interval for the HbA1c difference between treatments was <0.35%.
  
  
  
  Mean changes in HbA1c following addition of evogliptin or sitagliptin were -0.59% and -0.65%, respectively. The between-group difference was 0.06% (2-sided 95% confidence interval, -0.10 to 0.22), demonstrating non-inferiority. After the 52-week treatment, evogliptin caused a persistently decreased level of HbA1c (-0.44% ± 0.65%, P  < .0001). In general, both treatments were well tolerated, with incidences and types of adverse events comparable between the two groups. Hypoglycaemic events, mostly mild, were reported in 0.9% of patients treated with evogliptin and in 2.8% of patients treated with sitagliptin for 24 weeks.
  
  
  
  Evogliptin 5 mg added to metformin therapy effectively improved glycaemic control and was non-inferior to sitagliptin and well tolerated in patients with type 2 diabetes mellitus that was inadequately controlled by metformin alone.
authors.affiliation: Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, Republic of Korea.
authors.forename: Sang-Mo
authors.identifier: 0000-0002-8535-0565
authors.initials: SM
authors.lastname: Hong
authors.affiliation: Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Cheol-Young
authors.initials: CY
authors.lastname: Park
authors.affiliation: Data Management and Clinical Statistics Team, Dong-A ST, Seoul, Republic of Korea.
authors.forename: Dong-Min
authors.initials: DM
authors.lastname: Hwang
authors.affiliation: Department of Internal Medicine, Eulji University College of Medicine, Daejeon, Republic of Korea.
authors.forename: Kyung Ah
authors.initials: KA
authors.lastname: Han
authors.affiliation: Department of Internal Medicine, College of Medicine, Hanyang University, Seoul, Republic of Korea.
authors.forename: Chang Beom
authors.initials: CB
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea.
authors.forename: Choon Hee
authors.initials: CH
authors.lastname: Chung
authors.affiliation: Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
authors.forename: Kun-Ho
authors.initials: KH
authors.lastname: Yoon
authors.affiliation: Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon-si, Republic of Korea.
authors.forename: Ji-Oh
authors.initials: JO
authors.lastname: Mok
authors.affiliation: Department of Internal Medicine, College of Medicine, Seoul National University, Seoul, Republic of Korea.
authors.forename: Kyong Soo
authors.initials: KS
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Sung-Woo
authors.initials: SW
authors.lastname: Park
mesh_terms: D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016903:Drug Monitoring; D004351:Drug Resistance; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D015994:Incidence; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D056910:Republic of Korea / Q000453:epidemiology; D000068900:Sitagliptin Phosphate / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D010879:Piperazines; D000068900:Sitagliptin Phosphate; C557982:4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one; C517652:hemoglobin A1c protein, human
keywords: 
  DPP-4 inhibitor; combination therapy; evogliptin; metformin; sitagliptin; type 2 diabetes mellitus