title: Efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes mellitus: a 24-week multicentre, randomized, double-blind, placebo-controlled phase III trial.
abstract: We assessed the 24-week efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes mellitus (T2DM) that was inadequately controlled with diet and exercise. The present study was designed as a multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study. Patients (n = 142) were randomized 2 : 1 into two different treatment groups as follows: 99 received teneligliptin (20 mg) and 43 received placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) level from baseline to week 24. Teneligliptin significantly reduced the HbA1c level from baseline compared with placebo after 24 weeks. At week 24, the differences between changes in HbA1c and fasting plasma glucose (FBG) in the teneligliptin and placebo groups were -0.94% [least-squares (LS) mean -1.22, -0.65] and -1.21 mmol/l (-1.72, -0.70), respectively (all p < 0.001). The incidence of hypoglycaemia and adverse events were not significantly different between the two groups. This phase III, randomized, placebo-controlled study provides evidence of the safety and efficacy of 24 weeks of treatment with teneligliptin as a monotherapy in Korean patients with T2DM.
authors.affiliation: Department of Internal Medicine, College of Medicine, Hanyang University, Seoul, Korea.
authors.forename: S
authors.initials: S
authors.lastname: Hong
authors.affiliation: Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: C-Y
authors.initials: CY
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Eulji University College of Medicine, Seoul, Korea.
authors.forename: K A
authors.initials: KA
authors.lastname: Han
authors.affiliation: Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.
authors.forename: C H
authors.initials: CH
authors.lastname: Chung
authors.affiliation: Division of Endocrinology, Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea.
authors.forename: B J
authors.initials: BJ
authors.lastname: Ku
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: H C
authors.initials: HC
authors.lastname: Jang
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: C W
authors.initials: CW
authors.lastname: Ahn
authors.affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: M-K
authors.initials: MK
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: M K
authors.initials: MK
authors.lastname: Moon
authors.affiliation: Department of Internal Medicine, Uijeognbu St. Mary's Hospital, Catholic University Medical College, Uijeongbu, Korea.
authors.forename: H S
authors.initials: HS
authors.lastname: Son
authors.affiliation: Department of Internal Medicine, College of Medicine, Hanyang University, Seoul, Korea.
authors.forename: C B
authors.initials: CB
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, CHA Bungdang Medical Center, CHA University College of Medicine, Seongnam, Korea.
authors.forename: Y-W
authors.initials: YW
authors.lastname: Cho
authors.affiliation: Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: S-W
authors.initials: SW
authors.lastname: Park
mesh_terms: D000284:Administration, Oral; D001786:Blood Glucose / Q000032:analysis; D003131:Combined Modality Therapy / Q000009:adverse effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000178:diet therapy / Q000188:drug therapy* / Q000628:therapy; D003927:Diet, Diabetic; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D015444:Exercise; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000453:epidemiology / Q000517:prevention & control*; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D015994:Incidence; D007333:Insulin Resistance; D010349:Patient Compliance; D011720:Pyrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D056910:Republic of Korea / Q000453:epidemiology; D053778:Thiazolidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors
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-IV inhibitor; antidiabetic drug; phase III study; type 2 diabetes