PMID- 32856226
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210118
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 11
IP  - 10
DP  - 2020 Oct
TI  - Comparison of Blood Glucose Variability Between Exenatide and Biphasic Insulin 
      Aspart 30 in Chinese Participants with Type 2 Diabetes Inadequately Controlled 
      with Metformin Monotherapy: A Multicenter, Open-Label, Randomized Trial.
PG  - 2313-2328
LID - 10.1007/s13300-020-00904-z [doi]
AB  - INTRODUCTION: To compare blood glucose variability (GV) in Chinese participants 
      with type 2 diabetes mellitus (T2DM) whose blood glucose levels are inadequately 
      controlled with metformin monotherapy after twice-daily exenatide or biphasic 
      insulin aspart 30 (BIAsp30). METHODS: In this 16-week multicenter, randomized 
      clinical trial, 104 participants were randomized 1:1 to receive exenatide 
      (exenatide group) or BIAsp30 (BIAsp30 group) twice daily. All participants 
      continued metformin treatment. The primary outcome was the change in GV as 
      measured by a continuous glucose monitoring system (CGMS) from baseline to 
      16 weeks. RESULTS: At 16 weeks, both the Exenatide and BIAsp30 groups effectively 
      decreased mean glucose (MG), but neither group changed the mean amplitude of 
      glycemic excursion (MAGE), largest amplitude of glycemic excursion (LAGE), mean 
      of daily difference (MODD), or standard deviation of blood glucose (SDBG). The 
      decrease in 2-h post-breakfast glucose excursions was greater in the Exenatide 
      group compared to the BIAsp30 group, with a least square (LS) mean difference 
      [95% CI] of (1.58 [0.53, 2.63]). Exenatide also significantly reduced 2-h 
      post-lunch glucose excursion compared to BIAsp30 (LS mean difference [95% CI], 
      1.19 [0.18, 2.20]). The Exenatide group had significantly reduced body weight and 
      body mass index (BMI), while the BIAsp30 group had increased weight and had no 
      change in BMI. Both treatments were well tolerated with no serious hypoglycemic 
      events and with fewer identified hypoglycemic events in the Exenatide group than 
      in the BIAsp30 group (5.77% vs. 17.31%, P < 0.01). CONCLUSION: Although there was 
      no difference in change of GV between Exenatide and BIAsp30, exenatide provided 
      more improvement in postprandial glucose excursion and weight control, without 
      increasing the risk of hypoglycemia in Chinese patients with T2DM whose blood 
      glucose was inadequately controlled with metformin. These findings may provide 
      new options for patients who choose further hypoglycemic treatment, especially in 
      patients with obesity who have large postprandial plasma glucose excursions. 
      TRIAL REGISTRATION: ClinicalTrials.gov indentifier: NCT02449603.
FAU - Wang, Li
AU  - Wang L
AD  - Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, 
      Xi'an, China.
FAU - Liu, Xiangyang
AU  - Liu X
AD  - Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, 
      Xi'an, China.
FAU - Yang, Wenjuan
AU  - Yang W
AD  - Department of Endocrinology, Shaanxi Aerospace Hospital, Xi'an, Shaanxi, China.
FAU - Lai, Jingbo
AU  - Lai J
AD  - Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, 
      Xi'an, China.
FAU - Yu, Xinwen
AU  - Yu X
AD  - Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, 
      Xi'an, China.
FAU - Liu, Jianrong
AU  - Liu J
AD  - Department of Endocrinology, Xi'an Chang an Hospital, Xi'an, Shaanxi, China.
FAU - Gao, Xiling
AU  - Gao X
AD  - Department of Endocrinology, Yan'an People's Hospital, Yan'an, Shaanxi, China.
FAU - Ming, Jie
AU  - Ming J
AD  - Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, 
      Xi'an, China.
FAU - Ma, Kaiyan
AU  - Ma K
AD  - Department of Endocrinology, Shangluo Central Hospital, Shangluo, Shaanxi, China.
FAU - Xu, Jing
AU  - Xu J
AD  - Department of Endocrinology, Second Affiliated Hospital of Xi'an Jiaotong 
      University, Xi'an, Shaanxi, China.
FAU - Tian, Zhufang
AU  - Tian Z
AD  - Department of Endocrinology, Xi'an Central Hospital, Xi'an, Shaanxi, China.
FAU - He, Qingzhen
AU  - He Q
AD  - Department of Endocrinology, Xi'an Gaoxin Hospital, Xi'an, Shaanxi, China.
FAU - Ji, Qiuhe
AU  - Ji Q
AUID- ORCID: 0000-0002-3010-5837
AD  - Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, 
      Xi'an, China. qiuheji@hotmail.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT02449603
GR  - ESR-14-10319/AstraZeneca China and 3SBio Inc/
GR  - 2017YFC1309803/Nation Key Research and Development Program of China/
GR  - 2017ZDCXLSF0201/Key Research and Development Program of Shaanxi Province, China/
PT  - Journal Article
DEP - 20200827
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC7509011
OTO - NOTNLM
OT  - Biphasic insulin aspart 30 (BIAsp30)
OT  - Continuous glucose monitoring system (CGMS)
OT  - Exenatide
OT  - Glucose variability
OT  - Postprandial glucose excursion
EDAT- 2020/08/29 06:00
MHDA- 2020/08/29 06:01
PMCR- 2020/08/27
CRDT- 2020/08/29 06:00
PHST- 2020/06/02 00:00 [received]
PHST- 2020/08/29 06:00 [pubmed]
PHST- 2020/08/29 06:01 [medline]
PHST- 2020/08/29 06:00 [entrez]
PHST- 2020/08/27 00:00 [pmc-release]
AID - 10.1007/s13300-020-00904-z [pii]
AID - 904 [pii]
AID - 10.1007/s13300-020-00904-z [doi]
PST - ppublish
SO  - Diabetes Ther. 2020 Oct;11(10):2313-2328. doi: 10.1007/s13300-020-00904-z. Epub 
      2020 Aug 27.