PMID- 33256337
OWN - NLM
STAT- MEDLINE
DCOM- 20210126
LR  - 20221207
IS  - 0578-1426 (Print)
IS  - 0578-1426 (Linking)
VI  - 59
IP  - 12
DP  - 2020 Dec 1
TI  - [Efficacy and safety of Changsulin((R)) compared with Lantus((R)) in type 2 diabetes: 
      a phase Ⅲ multicenter, randomized, open-label, parallel, controlled clinical 
      trial].
PG  - 960-967
LID - 10.3760/cma.j.cn112138-20200423-00417 [doi]
AB  - Objective: To compare the efficacy and safety of Changsulin((R)) with Lantus((R)) in 
      treating patients with type 2 diabetes mellitus (T2DM). Methods: This was a phase 
      Ⅲ, multicenter, randomized, open-label, parallel-group, active-controlled 
      clinical trial. A total of 578 participants with T2DM inadequately controlled on 
      oral hypoglycemic agents were randomized 3ratio1 to Changsulin((R)) or Lantus((R)) 
      treatment for 24 weeks. The efficacy measures included changes in glycosylated 
      hemoglobin (HbA1c), fasting plasma glucose (FPG), 2h postprandial plasma glucose 
      (2hPG), 8-point self-monitoring of blood glucose (SMBG) profiles from baseline, 
      and proportions of subjects achieving targets of HbA1c and FPG. The safety 
      outcomes included rates of hypoglycemia, adverse events (AEs) and anti-insulin 
      glargine antibody. Results: After 24 weeks of treatment, mean HbAlc decreased 
      1.16% and 1.25%, FPG decreased 3.05 mmol/L and 2.90 mmol/L, 2hPG decreased 2.49 
      mmol/L and 2.38 mmol/L in Changsulin((R)) and in Lantus((R)), respectively. No 
      significant differences could be viewed in above parameters between the two 
      groups (all P>0.05). There were also no significant differences between 
      Changsulin((R)) and Lantus((R)) in 8-point SMBG profiles from baseline and 
      proportions of subjects achieving the targets of HbA1c and FPG (all P>0.05). The 
      rates of total hypoglycemia (38.00% and 39.01% for Changsulin((R)) and Lantus((R)), 
      respectively) and nocturnal hypoglycemia (17.25% and 16.31% for Changsulin((R)) and 
      Lantus((R)), respectively) were similar between the two groups (all P>0.05). Most 
      of the hypoglycemia events were asymptomatic, and no severe hypoglycemia were 
      found in both groups. No differences were observed in rates of AEs (61.77% 
      vs.52.48%) and anti-insulin glargine antibody (after 24 weeks of treatment, 6.91% 
      vs.3.65%) between the two groups (all P>0.05). Conclusions: Changsulin((R)) shows 
      similar efficacy and safety profiles compared with Lantus((R)) and Changsulin((R)) 
      treatment was well tolerated in patients with T2DM.
FAU - Zhang, T T
AU  - Zhang TT
AD  - Department of Endocrinology, Peking University First Hospital, Beijing 100034, 
      China.
FAU - Liu, X M
AU  - Liu XM
AD  - Department of Endocrinology, The First Affiliated Hospital of Harbin Medical 
      University, Harbin 150001, China.
FAU - Shi, B Y
AU  - Shi BY
AD  - Department of Endocrinology, The First Affiliated Hospital of Xi'an Jiao Tong 
      University, Xi'an 710061, China.
FAU - Wang, C J
AU  - Wang CJ
AD  - Department of Endocrinology, The First Affiliated Hospital of Anhui Medical 
      University, Hefei 230022, China.
FAU - Mo, Z H
AU  - Mo ZH
AD  - Department of Endocrinology, The Third Xiangya Hospital of Central South 
      University, Changsha 410013, China.
FAU - Liu, Y
AU  - Liu Y
AD  - Department of Endocrinology, The Second Hospital of Jilin University, Changchun 
      130041, China.
FAU - Shan, Z Y
AU  - Shan ZY
AD  - Department of Endocrinology, The First Affiliated Hospital of China Medical 
      University, Shenyang 110001, China.
FAU - Yang, W Y
AU  - Yang WY
AD  - Department of Endocrinology, China-Japan Friendship Hospital, Beijing 100029, 
      China.
FAU - Li, Q M
AU  - Li QM
AD  - Department of Endocrinology, PLA Rocket Force General Hospital, Beijing 100088, 
      China.
FAU - Lyu, X F
AU  - Lyu XF
AD  - Department of Endocrinology, PLA Army General Hospital, Beijing 100700, China.
FAU - Yang, J K
AU  - Yang JK
AD  - Department of Endocrinology, Beijing Tongren Hospital, Capital Medical 
      University, Beijing 100730, China.
FAU - Xue, Y M
AU  - Xue YM
AD  - Department of Endocrinology, Nanfang Hospital of Nanfang Medical University, 
      Guangzhou 510515, China.
FAU - Zhu, D L
AU  - Zhu DL
AD  - Department of Endocrinology, Nanjing Drum Tower Hospital, The Affiliated Hospital 
      of Nanjing University Medical School, Nanjing 210008, China.
FAU - Shi, Y Q
AU  - Shi YQ
AD  - Department of Endocrinology, Shanghai Changzheng Hospital, Shanghai 200003, 
      China.
FAU - Huang, Q
AU  - Huang Q
AD  - Department of Endocrinology, Shanghai Changhai Hospital, Shanghai 200433, China.
FAU - Zhou, Z G
AU  - Zhou ZG
AD  - Department of Endocrinology, The Second Xiangya Hospital of Central South 
      University, Changsha 410011, China.
FAU - Wang, Q
AU  - Wang Q
AD  - Department of Endocrinology, China-Japan Friendship Hospital, Beijing 100029, 
      China.
FAU - Ji, Q H
AU  - Ji QH
AD  - Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, 
      Xi'an 710032, China.
FAU - Li, Y B
AU  - Li YB
AD  - Department of Endocrinology, The First Affiliated Hospital of Sun Yat-sen 
      University, Guangzhou 510080, China.
FAU - Gao, X
AU  - Gao X
AD  - Department of Endocrinology, Zhongshan Hospital of Fudan University, Shanghai 
      200032, China.
FAU - Lu, J M
AU  - Lu JM
AD  - Department of Endocrinology, The First Medical Center, Chinese PLA General 
      Hospital, Beijing 100853, China.
FAU - Zhang, J Q
AU  - Zhang JQ
AD  - Department of Endocrinology, Peking University First Hospital, Beijing 100034, 
      China.
FAU - Guo, X H
AU  - Guo XH
AD  - Department of Endocrinology, Peking University First Hospital, Beijing 100034, 
      China.
LA  - chi
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - China
TA  - Zhonghua Nei Ke Za Zhi
JT  - Zhonghua nei ke za zhi
JID - 16210490R
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 2ZM8CX04RZ (Insulin Glargine)
SB  - IM
MH  - Blood Glucose/analysis
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemia
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Insulin Glargine/*therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Diabetes mellitus, type 2
OT  - Efficacy
OT  - Insulin glargine
OT  - Safety
EDAT- 2020/12/02 06:00
MHDA- 2021/01/27 06:00
CRDT- 2020/12/01 01:53
PHST- 2020/12/01 01:53 [entrez]
PHST- 2020/12/02 06:00 [pubmed]
PHST- 2021/01/27 06:00 [medline]
AID - 10.3760/cma.j.cn112138-20200423-00417 [doi]
PST - ppublish
SO  - Zhonghua Nei Ke Za Zhi. 2020 Dec 1;59(12):960-967. doi: 
      10.3760/cma.j.cn112138-20200423-00417.