PMID- 33855222
OWN - NLM
STAT- MEDLINE
DCOM- 20211018
LR  - 20221207
IS  - 2398-9238 (Electronic)
IS  - 2398-9238 (Linking)
VI  - 4
IP  - 2
DP  - 2021 Apr
TI  - Efficacy and safety of teneligliptin added to metformin in Chinese patients with 
      type 2 diabetes mellitus inadequately controlled with metformin: A phase 3, 
      randomized, double-blind, placebo-controlled study.
PG  - e00222
LID - 10.1002/edm2.222 [doi]
LID - e00222
AB  - INTRODUCTION: We evaluated the efficacy and safety of teneligliptin compared with 
      placebo when added to metformin therapy in Chinese patients with type 2 diabetes 
      inadequately controlled with metformin monotherapy. METHODS: This multicentre, 
      randomized, double-blind, placebo-controlled, parallel-group study enrolled type 
      2 diabetes patients with glycosylated haemoglobin (HbA1c) 7.0%-<10.0% and fasting 
      plasma glucose (FPG) <270 mg/dl, receiving a stable metformin dose >/=1000 mg/day. 
      Teneligliptin 20 mg or placebo was administered orally once daily (qd) before 
      breakfast for 24 weeks. The primary efficacy end-point was change in HbA1c from 
      baseline to Week 24. Safety end-points included the incidence of adverse events 
      (AEs). RESULTS: The least square mean (LSM) change from baseline (standard error 
      [SE]) was -0.72 (0.07) (95% confidence intervals [CI], -0.87, -0.58) for 
      teneligliptin and -0.01 (0.07) (95% CI, -0.16, 0.13) for placebo. The differences 
      (LSM +/- SE) between the placebo and teneligliptin groups in HbA1c and FPG were 
      -0.71% +/- 0.11% (p < .0001) and -16.5 +/- 4.7 mg/dl (p = .0005), respectively. 
      Teneligliptin yielded significant changes in HbA1c (-0.81%; p < .0001) and FPG 
      (-22.2 mg/dl; p < .0001) at Week 12. At Week 24, more patients achieved HbA1c 
      <7.0% with teneligliptin (41.7%) compared with placebo (16.1%; p < .0001). 
      Treatment-emergent AE incidence was similar with teneligliptin (58.9%) and 
      placebo (68.3%); upper respiratory tract infection, hyperuricaemia and 
      hyperlipidaemia were the most common AEs. CONCLUSIONS: Teneligliptin 20 mg qd for 
      24 weeks added to ongoing metformin treatment significantly decreased HbA1c and 
      FPG levels compared with placebo in Chinese type 2 diabetes patients. The 
      combination was safe and tolerable.
CI  - (c) 2021 The Authors. Endocrinology, Diabetes & Metabolism published by John Wiley 
      & Sons Ltd.
FAU - Ji, Linong
AU  - Ji L
AUID- ORCID: 0000-0003-1305-1598
AD  - Peking University People's Hospital, Beijing, China.
FAU - Li, Ling
AU  - Li L
AD  - Shengjing Hospital of China Medical University, Liaoning, China.
FAU - Ma, Jianhua
AU  - Ma J
AD  - Nanjing First Hospital, Nanjing, Jiangsu, China.
FAU - Li, Xuefeng
AU  - Li X
AD  - Shiyan Taihe Hospital, Hubei, China.
FAU - Li, Dongmei
AU  - Li D
AD  - Inner Mongolia People's Hospital, Inner Mongolia, China.
FAU - Meng, Bangzhu
AU  - Meng B
AD  - The Affiliated Hospital of Inner Mongolia University for Nationalities, Inner 
      Mongolia, China.
FAU - Lu, Weiping
AU  - Lu W
AD  - Huai'an First People's Hospital, Nanjing Medical University, Nanjing, Jiangsu, 
      China.
FAU - Sun, Jiao
AU  - Sun J
AD  - Huadong Hospital Affiliated to Fudan University, Shanghai, China.
FAU - Liu, Yanmei
AU  - Liu Y
AD  - Yancheng City No.1 People's Hospital, Jiangsu, China.
FAU - Takayanagi, Gen
AU  - Takayanagi G
AD  - Mitsubishi Tanabe Pharma Development America, Inc., Jersey City, NJ, USA.
FAU - Wang, Yi
AU  - Wang Y
AUID- ORCID: 0000-0001-6280-6593
AD  - Mitsubishi Tanabe Pharma Development (Beijing) Co., Ltd., Beijing, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT02888691
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210120
PL  - England
TA  - Endocrinol Diabetes Metab
JT  - Endocrinology, diabetes & metabolism
JID - 101732442
RN  - 0 
      (3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine)
RN  - 0 (Biomarkers)
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Placebos)
RN  - 0 (Pyrazoles)
RN  - 0 (Thiazolidines)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 9100L32L2N (Metformin)
SB  - IM
MH  - Asian People
MH  - Biomarkers/blood
MH  - Blood Glucose
MH  - Diabetes Mellitus, Type 2/blood/diagnosis/*drug therapy
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Fasting/blood
MH  - Glycated Hemoglobin
MH  - Glycemic Control/*methods
MH  - Humans
MH  - Metformin/*administration & dosage
MH  - Placebos
MH  - Pyrazoles/*administration & dosage
MH  - Safety
MH  - Thiazolidines/*administration & dosage
MH  - Treatment Outcome
PMC - PMC8029565
OTO - NOTNLM
OT  - diabetes mellitus
OT  - dipeptidyl peptidase-IV inhibitors
OT  - metformin
OT  - type 2
COIS- Linong Ji has received personal fees from Mitsubishi Tanabe Pharma Development 
      (Beijing) Co., Ltd. Yi Wang is an employee of Mitsubishi Tanabe Pharma 
      Development (Beijing) Co., Ltd. Gen Takayanagi is an employee of Mitsubishi 
      Tanabe Pharma Development America, Inc. The remaining authors have no conflicts 
      of interest to declare.
EDAT- 2021/04/16 06:00
MHDA- 2021/10/21 06:00
PMCR- 2021/01/20
CRDT- 2021/04/15 07:25
PHST- 2020/07/30 00:00 [received]
PHST- 2020/12/09 00:00 [revised]
PHST- 2020/12/19 00:00 [accepted]
PHST- 2021/04/15 07:25 [entrez]
PHST- 2021/04/16 06:00 [pubmed]
PHST- 2021/10/21 06:00 [medline]
PHST- 2021/01/20 00:00 [pmc-release]
AID - EDM2222 [pii]
AID - 10.1002/edm2.222 [doi]
PST - epublish
SO  - Endocrinol Diabetes Metab. 2021 Jan 20;4(2):e00222. doi: 10.1002/edm2.222. 
      eCollection 2021 Apr.