PMID- 33945841
OWN - NLM
STAT- MEDLINE
DCOM- 20210706
LR  - 20221207
IS  - 1872-8227 (Electronic)
IS  - 0168-8227 (Linking)
VI  - 176
DP  - 2021 Jun
TI  - Comparison of insulin glargine 300 U/mL versus glargine 100 U/mL on glycemic 
      control and hypoglycemic events in East Asian patients with type 2 diabetes: A 
      Patient-level meta-analysis of phase 3 studies.
PG  - 108848
LID - S0168-8227(21)00207-2 [pii]
LID - 10.1016/j.diabres.2021.108848 [doi]
AB  - AIMS: To evaluate efficacy and safety of Gla-300 with Gla-100 in a patient-level 
      meta-analysis among large East Asian patients with type 2 diabetes mellitus 
      (T2DM). METHODS: A patient level meta-analysis of three EDITION studies with 
      similar design and endpoints were conducted over 6-months treatment period. The 
      analysis included 547 patients treated with Gla-300 and 348 patients treated with 
      Gla-100. RESULTS: Over 6-month treatment period, mean change in HbA1c was similar 
      for Gla-300 [Least square (LS) mean, (SE): -1.13 (0.05) % and Gla-100: -1.14 
      (0.05) %], showing non-inferiority of Gla-300 to Gla-100 (LS mean difference: 
      0.02%, 95% CI: -0.08 to 0.11). Gla-300 was associated with reduced risk of 
      hypoglycemic event (confirmed </= 3.9 mmol/L or severe) vs Gla-100 at any time of 
      day or at night (00:00-05:59 h). The event rates of hypoglycemia were 
      consistently lower with Gla-300 than Gla-100. Severe hypoglycemia was rare in 
      both treatment groups. Weight gain was minimal in both treatment groups. 
      CONCLUSION: Gla-300 provides comparable glycemic control to Gla-100 in East Asian 
      patients with broad clinical spectrum of T2DM, with consistently less 
      hypoglycemia at any time of the day and night.
CI  - Copyright (c) 2021 The Authors. Published by Elsevier B.V. All rights reserved.
FAU - Ji, Linong
AU  - Ji L
AD  - Peking University People's Hospital, China. Electronic address: jiln@bjmu.edu.cn.
FAU - Bi, Yan
AU  - Bi Y
AD  - Drum Tower Hospital Affiliated to Nanjing University Medical School, China.
FAU - Ye, Shandong
AU  - Ye S
AD  - The First Affiliated Hospital of University of Science and Technology of China, 
      China.
FAU - Huang, Yun
AU  - Huang Y
AD  - Sanofi, Shanghai, China.
FAU - Zhang, Xia
AU  - Zhang X
AD  - Sanofi, Shanghai, China.
FAU - Shang, Shuhua
AU  - Shang S
AD  - Sanofi, Shanghai, China.
FAU - Cui, Nan
AU  - Cui N
AD  - Sanofi, Shanghai, China.
FAU - Yin, Huiqiu
AU  - Yin H
AD  - Sanofi, Shanghai, China.
FAU - Zhang, Minlu
AU  - Zhang M
AD  - Sanofi, Shanghai, China.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20210501
PL  - Ireland
TA  - Diabetes Res Clin Pract
JT  - Diabetes research and clinical practice
JID - 8508335
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 2ZM8CX04RZ (Insulin Glargine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Asian People
MH  - Clinical Trials, Phase III as Topic/statistics & numerical data
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy/ethnology
MH  - Dose-Response Relationship, Drug
MH  - Asia, Eastern/ethnology
MH  - Female
MH  - Glycated Hemoglobin/analysis/drug effects/metabolism
MH  - Glycemic Control/adverse effects/*methods
MH  - Humans
MH  - Hypoglycemia/chemically induced/epidemiology
MH  - Hypoglycemic Agents/administration & dosage/adverse effects
MH  - Insulin Glargine/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Multicenter Studies as Topic/statistics & numerical data
MH  - Randomized Controlled Trials as Topic/statistics & numerical data
MH  - Weight Gain/drug effects/ethnology
OTO - NOTNLM
OT  - Asians
OT  - Diabetes
OT  - EDITION
OT  - HbA1c
OT  - Insulin glargine
OT  - Pooled analysis
COIS- Declaration of Competing Interest The authors declare that they have no known 
      competing financial interests or personal relationships that could have appeared 
      to influence the work reported in this paper. L.J. reports receiving consulting 
      and lecture fees from Eli Lilly, Bristol-Myers Squibb, Novartis, Novo Nordisk, 
      Merck, Bayer, Takeda, Sanofi, Roche and Boehringer Ingelheim and research grants 
      from Roche and Sanofi. Y.B. reports receiving lecture fees from Eli Lilly, 
      Bristol-Myers Squibb, Novartis, Novo Nordisk, Merck, Bayer, Sanofi, Roche and 
      Boehringer Ingelheim. S.Y. has no conflicts of interests. Y.H., X.Z., S.S, N.C., 
      H.Y. and M.Z. are employees of Sanofi.
EDAT- 2021/05/05 06:00
MHDA- 2021/07/07 06:00
CRDT- 2021/05/04 20:11
PHST- 2021/02/10 00:00 [received]
PHST- 2021/04/23 00:00 [revised]
PHST- 2021/04/28 00:00 [accepted]
PHST- 2021/05/05 06:00 [pubmed]
PHST- 2021/07/07 06:00 [medline]
PHST- 2021/05/04 20:11 [entrez]
AID - S0168-8227(21)00207-2 [pii]
AID - 10.1016/j.diabres.2021.108848 [doi]
PST - ppublish
SO  - Diabetes Res Clin Pract. 2021 Jun;176:108848. doi: 10.1016/j.diabres.2021.108848. 
      Epub 2021 May 1.