PMID- 31228090
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 10
IP  - 4
DP  - 2019 Aug
TI  - Efficacy and Safety of Dulaglutide Versus Insulin Glargine in Chinese T2DM 
      Patients: A Subgroup Analysis of a Randomized Trial (AWARD-CHN2).
PG  - 1435-1452
LID - 10.1007/s13300-019-0646-y [doi]
AB  - INTRODUCTION: To evaluate efficacy and safety data of dulaglutide in Chinese 
      patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control 
      with 1-2 oral antihyperglycemic medications (OAMs). METHODS: This is a subgroup 
      analysis of a phase 3, open-label, randomized, parallel-arm, 52-week study in 
      Chinese patients aged >/= 18 years with T2DM who had inadequate glycemic control 
      with OAMs (glycated hemoglobin [HbA1c] >/= 7.0% and </= 11.0%). The primary endpoint 
      was assessment of the noninferiority of dulaglutide 1.5 mg as measured by change 
      in HbA1c, compared with insulin glargine (glargine), using a 0.4% noninferiority 
      margin at week 26. RESULTS: A total of 607 patients from China were randomized 
      1:1:1 to once-weekly dulaglutide 1.5 or 0.75 mg or once-daily glargine. At week 
      26, the least squares mean (LSM) change from baseline in HbA1c was greater with 
      dulaglutide 1.5 mg (- 1.67%) and dulaglutide 0.75 mg (- 1.31%) compared with 
      glargine (- 1.11%). The LSM (95% confidence interval) for the difference of 
      dulaglutide 1.5 mg and 0.75 mg vs glargine was - 0.56% (- 0.75 to - 0.37) and 
      - 0.20% (- 0.39 to - 0.01), respectively. Both doses of dulaglutide were 
      noninferior and superior to glargine at 26 weeks and 52 weeks (two-sided P 
      value < 0.05). The mean body weight decreased (P < 0.001) and total hypoglycemia 
      rates were lower (P < 0.05) in the dulaglutide groups compared with the glargine 
      group. Gastrointestinal adverse events (AEs) were the most frequently reported 
      AEs in dulaglutide groups. CONCLUSION: Both doses of dulaglutide are efficacious 
      and tolerable in Chinese patients with T2DM who had inadequate glycemic control 
      on OAMs. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01648582. FUNDING: 
      Eli Lilly and Company.
FAU - Li, Yan
AU  - Li Y
AD  - Department of Endocrinology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen 
      University, Guangzhou, Guangdong, China.
FAU - Li, Ling
AU  - Li L
AD  - Department of Endocrinology, Shengjing Hospital of China Medical University, 
      Shenyang, Liaoning, China.
FAU - De Peng, Yong
AU  - De Peng Y
AD  - Department of Endocrinology, Shanghai First People's Hospital, Shanghai, China.
FAU - Song, Guang Yao
AU  - Song GY
AD  - Department of Endocrinology, Hebei General Hospital, Shijiazhuang, Hebei, China.
FAU - Ye, Shan Dong
AU  - Ye SD
AD  - Anhui Provincial Hospital, Hefei, Anhui, China.
FAU - Du, Li Ying
AU  - Du LY
AD  - Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.
FAU - Hou, Jia Ning
AU  - Hou JN
AUID- ORCID: 0000-0002-7210-0110
AD  - Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China. hou_jia_ning@lilly.com.
FAU - Ji, Qiu He
AU  - Ji QH
AD  - Xijing Hospital, The Fourth Military Medical University, Xi'an, Shanxi, China. 
      jqiuhe@fmmu.edu.cn.
LA  - eng
SI  - ClinicalTrials.gov/NCT01648582
PT  - Journal Article
DEP - 20190621
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC6612357
OTO - NOTNLM
OT  - China
OT  - Dulaglutide
OT  - Glucagon-like peptide-1 receptor agonist
OT  - Glycated hemoglobin
OT  - Type 2 diabetes mellitus
EDAT- 2019/06/23 06:00
MHDA- 2019/06/23 06:01
PMCR- 2019/06/21
CRDT- 2019/06/23 06:00
PHST- 2019/04/04 00:00 [received]
PHST- 2019/06/23 06:00 [pubmed]
PHST- 2019/06/23 06:01 [medline]
PHST- 2019/06/23 06:00 [entrez]
PHST- 2019/06/21 00:00 [pmc-release]
AID - 10.1007/s13300-019-0646-y [pii]
AID - 646 [pii]
AID - 10.1007/s13300-019-0646-y [doi]
PST - ppublish
SO  - Diabetes Ther. 2019 Aug;10(4):1435-1452. doi: 10.1007/s13300-019-0646-y. Epub 
      2019 Jun 21.