PMID- 29227571
OWN - NLM
STAT- MEDLINE
DCOM- 20190111
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 20
IP  - 4
DP  - 2018 Apr
TI  - Comparative effectiveness of metformin monotherapy in extended release and 
      immediate release formulations for the treatment of type 2 diabetes in 
      treatment-naive Chinese patients: Analysis of results from the CONSENT trial.
PG  - 1006-1013
LID - 10.1111/dom.13190 [doi]
AB  - AIMS: Metformin treatment for type 2 diabetes mellitus (T2DM) can be limited by 
      gastrointestinal (GI) adverse events (AEs), resulting in treatment 
      discontinuation. We investigated whether once-daily metformin extended release 
      (XR) is superior in terms of GI tolerability, with non-inferior efficacy, 
      compared with thrice-daily metformin immediate release (IR) in treatment-naive 
      Chinese patients with T2DM. MATERIALS AND METHODS: This prospective, open-label, 
      randomized, multicentre, phase IV interventional study enrolled Chinese T2DM 
      patients to receive either metformin XR or metformin IR with a 2-week screening 
      period, a 16-week treatment period and a 2-week follow-up period without 
      treatment. Co-primary endpoints were a non-inferiority assessment of metformin XR 
      vs metformin IR in glycated haemoglobin (HbA1c) least squares mean (LSM) change 
      from baseline to week 16 and the superiority of GI tolerability for metformin XR 
      vs metformin IR. RESULTS: Overall, 532 patients were randomized to metformin IR 
      (n = 267) or metformin XR (n = 265). The HbA1c LSM change was -1.61% and -1.58% 
      in each group, respectively (LSM difference, 0.03; 95% confidence interval [CI], 
      -0.10, 0.17). Incidences of drug-related AEs were 26.5% (n = 66) in the metformin 
      IR-only group and 32.2% (n = 85) in the metformin XR-only group, and GI AEs were 
      23.8% and 22.3% in each group, respectively (difference, -1.52; 95% CI, -8.60, 
      5.56). The treatment difference met the predefined non-inferiority upper CI 
      margin of 0.4% in HbA1c. CONCLUSIONS: Metformin XR was non-inferior to metformin 
      IR for the LSM change in HbA1c from baseline to week 16 and not superior to 
      metformin IR for overall GI AE incidence during treatment of Chinese T2DM 
      patients.
CI  - (c) 2017 John Wiley & Sons Ltd.
FAU - Ji, Linong
AU  - Ji L
AUID- ORCID: 0000-0003-1305-1598
AD  - Department of Endocrinology, Peking University People's Hospital, Beijing, China.
FAU - Liu, Jing
AU  - Liu J
AD  - Department of Endocrinology, Gansu Provincial Hospital, Gansu, China.
FAU - Yang, Jing
AU  - Yang J
AD  - Department of Endocrinology, First Hospital of Shanxi Medical University, Shanxi, 
      China.
FAU - Li, Yufeng
AU  - Li Y
AD  - Department of Endocrinology, Beijing Pinggu Hospital, Beijing, China.
FAU - Liang, Li
AU  - Liang L
AD  - Department of Endocrinology, The People's Hospital of Liaoning Province, 
      Shenyang, China.
FAU - Zhu, Dalong
AU  - Zhu D
AD  - Department of Endocrinology, Nanjing Drum Tower Hospital (the Affiliated Hospital 
      of Nanjing University Medical School), Nanjing, China.
FAU - Li, Quanmin
AU  - Li Q
AD  - Department of Endocrinology, General Hospital of the Rocket Forces of Chinese 
      People's Liberation Army, Beijing, China.
FAU - Ma, Tianrong
AU  - Ma T
AUID- ORCID: 0000-0002-6835-4943
AD  - Medical Affairs, Merck China Ltd, an affiliate of Merck KGaA, Darmstadt, Germany.
FAU - Xu, Haiyan
AU  - Xu H
AD  - Medical Affairs, Merck China Ltd, an affiliate of Merck KGaA, Darmstadt, Germany.
FAU - Yang, Yanlan
AU  - Yang Y
AD  - Department of Endocrinology, Shanxi Provincial People's Hospital, Shanxi, China.
FAU - Zeng, Jiaoe
AU  - Zeng J
AD  - Department of Endocrinology, Jingzhou Central Hospital, Jingzhou, China.
FAU - Feng, Bo
AU  - Feng B
AD  - Department of Endocrinology, Shanghai East Hospital Affiliated to Tongji 
      University, Shanghai, China.
FAU - Qu, Shen
AU  - Qu S
AD  - Department of Endocrinology, Shanghai Tenth People's Hospital (Tenth People's 
      Hospital of Tongji University), Shanghai, China.
FAU - Li, Yiming
AU  - Li Y
AD  - Department of Endocrinology, Huashan Hospital Affiliated to Fudan University, 
      Shanghai, China.
FAU - Ma, Lizhen
AU  - Ma L
AD  - Department of Endocrinology, Hangzhou First People's Hospital, Hangzhou, China.
FAU - Lin, Shanshan
AU  - Lin S
AD  - Department of Endocrinology, Beijing Shijingshan Hospital, Beijing, China.
FAU - Wang, Jianping
AU  - Wang J
AD  - Department of Endocrinology, The Second Hospital Affiliated to University of 
      South China, Hengyang, China.
FAU - Li, Wei
AU  - Li W
AD  - Department of Endocrinology, The Affiliated Hospital of Xuzhou Medical College, 
      Xuzhou, China.
FAU - Song, Weihong
AU  - Song W
AD  - Department of Endocrinology, Chenzhou No.1 People's Hospital, Chenzhou, China.
FAU - Li, Xiaoxing
AU  - Li X
AD  - Department of Endocrinology, The Third Hospital of Changsha, Changsha, China.
FAU - Luo, Yong
AU  - Luo Y
AD  - Department of Endocrinology, Chongqing Three Gorges Central Hospital, Chongqing, 
      China.
FAU - Xi, Shugang
AU  - Xi S
AD  - Department of Endocrinology, The First Hospital of Jilin University, Jilin, 
      China.
FAU - Lin, Mei
AU  - Lin M
AD  - Department of Endocrinology, Wuhan Puai Hospital, Wuhan, China.
FAU - Liu, Yu
AU  - Liu Y
AD  - Department of Endocrinology, Sir Run Run Hospital Nanjing Medical University, 
      Nanjing, China.
FAU - Liang, Zerong
AU  - Liang Z
AD  - Department of Endocrinology, Chongqing Red Cross Hospital (People's Hospital of 
      Jiangbei District), Chongqing, China.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180122
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Delayed-Action Preparations)
RN  - 9100L32L2N (Metformin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Asian People
MH  - China
MH  - Delayed-Action Preparations
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Drug Compounding
MH  - Female
MH  - Humans
MH  - Male
MH  - Metformin/*administration & dosage/adverse effects
MH  - Middle Aged
MH  - Treatment Outcome
OTO - NOTNLM
OT  - metformin
OT  - type 2 diabetes
EDAT- 2017/12/12 06:00
MHDA- 2019/01/12 06:00
CRDT- 2017/12/12 06:00
PHST- 2017/09/25 00:00 [received]
PHST- 2017/11/30 00:00 [revised]
PHST- 2017/12/07 00:00 [accepted]
PHST- 2017/12/12 06:00 [pubmed]
PHST- 2019/01/12 06:00 [medline]
PHST- 2017/12/12 06:00 [entrez]
AID - 10.1111/dom.13190 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2018 Apr;20(4):1006-1013. doi: 10.1111/dom.13190. Epub 2018 
      Jan 22.