title: Efficacy and safety of teneligliptin, a dipeptidyl peptidase-4 inhibitor, combined with metformin in Korean patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled phase III trial.
abstract: The aim of the present study was to assess the efficacy and safety of teneligliptin in combination with metformin in Korean patients with type 2 diabetes mellitus who were inadequately controlled with metformin monotherapy. Patients [glycated haemoglobin (HbA1c) 7.0-10.0%, on stable metformin ≥1000 mg/day] were randomized 2 : 1 to receive 20 mg teneligliptin plus metformin (n = 136) or placebo plus metformin (n = 68). The primary endpoint was the change in HbA1c levels from baseline to week 16. The mean baseline HbA1c was 7.9% in the teneligliptin group and 7.8% in the placebo group. The differences between the teneligliptin and placebo groups regarding changes in HbA1c and fasting plasma glucose levels were -0.78 % and -1.24 mmol/l (22.42 mg/dl), respectively, at week 16. The incidence of adverse events was similar between the groups. The addition of teneligliptin once daily to metformin was effective and generally well tolerated in Korean patients with type 2 diabetes.
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: M K
authors.initials: MK
authors.lastname: Kim
authors.forename: E-J
authors.initials: EJ
authors.lastname: Rhee
authors.forename: K A
authors.initials: KA
authors.lastname: Han
authors.forename: A C
authors.initials: AC
authors.lastname: Woo
authors.forename: M-K
authors.initials: MK
authors.lastname: Lee
authors.forename: B J
authors.initials: BJ
authors.lastname: Ku
authors.forename: C H
authors.initials: CH
authors.lastname: Chung
authors.forename: K-A
authors.initials: KA
authors.lastname: Kim
authors.forename: H W
authors.initials: HW
authors.lastname: Lee
authors.forename: I B
authors.initials: IB
authors.lastname: Park
authors.forename: J Y
authors.initials: JY
authors.lastname: Park
authors.forename: H C
authors.initials: HC
authors.lastname: Chul Jang
authors.forename: K S
authors.initials: KS
authors.lastname: Park
authors.forename: W I
authors.initials: WI
authors.lastname: Jang
authors.forename: B Y
authors.initials: BY
authors.lastname: Cha
mesh_terms: D001786:Blood Glucose / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D005215:Fasting; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008687:Metformin / Q000627:therapeutic use*; D011720:Pyrazoles / Q000627:therapeutic use*; D056910:Republic of Korea / Q000208:ethnology; D053778:Thiazolidines / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; 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 inhibitors; Korean; metformin; teneligliptin