PMID- 32965075
OWN - NLM
STAT- MEDLINE
DCOM- 20210705
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 23
IP  - 1
DP  - 2021 Jan
TI  - Efficacy and safety of polyethylene glycol loxenatide monotherapy in type 2 
      diabetes patients: A multicentre, randomized, double-blind, placebo-controlled 
      phase 3a clinical trial.
PG  - 116-124
LID - 10.1111/dom.14198 [doi]
AB  - AIM: To evaluate the efficacy and safety of polyethylene glycol loxenatide 
      (PEX168) monotherapy in type 2 diabetes (T2D) patients in China. MATERIALS AND 
      METHODS: In a multicentred, randomized, double-blinded, placebo-controlled phase 
      3a clinical trial, 361 patients with inadequate glycaemic control (HbA1c 
      7.0%-10.5%, fasting plasma glucose <13.9 mmol/L) were randomized (1:1:1) for 
      weekly subcutaneous injections: placebo, PEX168/100 mug or PEX168/200 mug. The 
      24-week treatment was followed by a 28-week extension, during which 
      placebo-treated patients were randomly assigned to PEX168/100 mug or 
      PEX168/200 mug. The primary efficacy endpoint was the HbA1c change from baseline 
      to week 24. RESULTS: The three groups had similar demographics and baseline 
      characteristics. The HbA1c least-square mean (95% CI) change from baseline to 
      week 24 was greater for PEX168/100 mug (-1.02% [-1.21%, -0.83%]) and PEX168/200 mug 
      (-1.34% [-1.54%, -1.15%]) than for placebo (-0.17% [-0.36%, 0.02%]); 
      (superiority: P < .0001). The proportions of patients with less than 7% HbA1c in 
      the placebo, PEX168/100 mug and PEX168/200 mug groups were 15.7%, 34.7% and 46.6%, 
      respectively. Common gastrointestinal adverse events (AEs) were nausea (5.6%, 
      10.0% and 0% for PEX168/100 mug, PEX168/200 mug and placebo, respectively) and 
      vomiting (2.4%, 8.3% and 0% for PEX168/100 mug, PEX168/200 mug and placebo, 
      respectively). Six (1.6%) patients (PEX168/100 mug: N = 2 [1.6%], PEX168/200 mug: N 
      = 3 [2.5%] and placebo: N = 1 [0.8%]) discontinued treatment because of AEs. Four 
      (1.2%) patients (PEX168/100 mug: N = 3 [2.5%] and PEX168/200 mug: N = 1 [0.9%]) 
      developed PEX168 antidrug antibodies. CONCLUSION: PEX168 monotherapy 
      significantly improved glycaemic control in T2D patients with a safety profile 
      resembling that of other glucagon-like peptide-1 receptor agonists.
CI  - (c) 2020 John Wiley & Sons Ltd.
FAU - Shuai, Ying
AU  - Shuai Y
AD  - China-Japan Friendship Hospital, Beijing, China.
FAU - Yang, Gangyi
AU  - Yang G
AD  - Department of Endocrinology, The Second Affiliated Hospital, Chongqing Medical 
      University, Chongqing, China.
FAU - Zhang, Qiu
AU  - Zhang Q
AD  - Department of Endocrinology, The First Affiliated Hospital of Anhui Medical 
      University, Hefei, China.
FAU - Li, Wei
AU  - Li W
AD  - Department of Endocrinology, The Affiliated Hospital of Xuzhou Medical 
      University, Xuzhou, China.
FAU - Luo, Yong
AU  - Luo Y
AD  - The Center of Clinical Research of Endocrinology and Metabolic Diseases in 
      Chongqing and Department of Endocrinology, Chongqing Three Gorges Central 
      Hospital, Chongqing, China.
FAU - Ma, Jianhua
AU  - Ma J
AD  - Nanjing First Hospital, Nanjing, China.
FAU - Chen, Daoxiong
AU  - Chen D
AD  - Department of Endocrinology, People's Hospital of Hainan, Haikou, China.
FAU - Yang, Jialin
AU  - Yang J
AD  - Department of Endocrinology, Central Hospital of Minhang District, Minhang 
      Hospital Affiliated to Fudan University, Shanghai, China.
FAU - Wang, Xinjun
AU  - Wang X
AD  - The First Affiliated Hospital of Hainan Medical University, Haikou, China.
FAU - Hu, Ji
AU  - Hu J
AD  - Department of Endocrinology, The Second Affiliated Hospital of Soochow 
      University, Suzhou, China.
FAU - Xu, Ning
AU  - Xu N
AD  - Department of Endocrinology Medicine, Lianyungang First People's Hospital, 
      Affiliated Hospital of Xuzhou Medical College, Lianyungang, China.
FAU - Yang, Wenying
AU  - Yang W
AUID- ORCID: 0000-0002-6936-8108
AD  - China-Japan Friendship Hospital, Beijing, China.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20201008
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Peptides)
RN  - 0 (polyethylene glycol loxenatide)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
SB  - IM
MH  - Blood Glucose
MH  - China/epidemiology
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - Double-Blind Method
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects
MH  - Peptides
MH  - Polyethylene Glycols
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Chinese, GLP-1, PEX168, randomized controlled trial, type 2 diabetes
EDAT- 2020/09/24 06:00
MHDA- 2021/07/06 06:00
CRDT- 2020/09/23 09:04
PHST- 2020/04/24 00:00 [received]
PHST- 2020/09/07 00:00 [revised]
PHST- 2020/09/20 00:00 [accepted]
PHST- 2020/09/24 06:00 [pubmed]
PHST- 2021/07/06 06:00 [medline]
PHST- 2020/09/23 09:04 [entrez]
AID - 10.1111/dom.14198 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2021 Jan;23(1):116-124. doi: 10.1111/dom.14198. Epub 2020 
      Oct 8.