PMID- 37142540
OWN - NLM
STAT- MEDLINE
DCOM- 20230801
LR  - 20230801
IS  - 1878-0210 (Electronic)
IS  - 1878-0210 (Linking)
VI  - 17
IP  - 4
DP  - 2023 Aug
TI  - Response to insulin glargine 100 U/mL treatment in newly-defined subgroups of 
      type 2 diabetes: Post hoc pooled analysis of insulin-naive participants from nine 
      randomised clinical trials.
PG  - 379-385
LID - S1751-9918(23)00093-1 [pii]
LID - 10.1016/j.pcd.2023.04.010 [doi]
AB  - AIMS: To assess insulin glargine 100 U/mL (IGlar-100) treatment outcomes 
      according to newly-defined subgroups of type 2 diabetes mellitus (T2DM). METHODS: 
      Insulin-naive T2DM participants (n = 2684) from nine randomised clinical trials 
      initiating IGlar-100 were pooled and assigned to subgroups "Mild Age-Related 
      Diabetes (MARD)", "Mild Obesity Diabetes (MOD)", "Severe Insulin Resistant 
      Diabetes (SIRD)", and "Severe Insulin Deficient Diabetes (SIDD)", according to 
      age at onset of diabetes, baseline HbA1c, BMI, and fasting C-peptide using 
      sex-specific nearest centroid approach. HbA1c, FPG, hypoglycemia, insulin dose, 
      and body weight were analysed at baseline and 24 weeks. RESULTS: Subgroup 
      distribution was MARD 15.3 % (n = 411), MOD 39.8 % (n = 1067), SIRD 10.5 % 
      (n = 283), SIDD 34.4 % (n = 923). From baseline HbA1c 8.0-9.6% adjusted least 
      square mean reductions after 24 weeks were similar between subgroups (1.4-1.5 %). 
      SIDD was less likely to achieve HbA1c < 7.0 % (OR: 0.40 [0.29, 0.55]) than MARD. 
      While the final IGlar-100 dose (0.36 U/kg) in MARD was lower than in other 
      subgroups (0.46-0.50 U/kg), it had the highest hypoglycemia risk. SIRD had lowest 
      hypoglycemia risk and SIDD exhibited greatest body weight gain. CONCLUSIONS: 
      IGlar-100 lowered hyperglycemia similarly in all T2DM subgroups, but level of 
      glycemic control, insulin dose, and hypoglycemia risk differed between subgroups.
CI  - Crown Copyright (c) 2023. Published by Elsevier Ltd. All rights reserved.
FAU - Landgraf, Wolfgang
AU  - Landgraf W
AD  - Sanofi, Berlin, Germany. Electronic address: wolfgang.landgraf@sanofi.com.
FAU - Bigot, Gregory
AU  - Bigot G
AD  - Ividata Life Sciences, Levallois-Perret, France.
FAU - Frier, Brian M
AU  - Frier BM
AD  - The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.
FAU - Bolli, Geremia B
AU  - Bolli GB
AD  - University of Perugia School of Medicine, Department of Medicine, Section of 
      Endocrinology and Metabolism, Perugia, Italy.
FAU - Owens, David R
AU  - Owens DR
AD  - Swansea University, Diabetes Research Group Cymru, College of Medicine, Swansea, 
      UK.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20230502
PL  - England
TA  - Prim Care Diabetes
JT  - Primary care diabetes
JID - 101463825
RN  - 2ZM8CX04RZ (Insulin Glargine)
RN  - 0 (Insulin)
RN  - 0 (Glycated Hemoglobin)
RN  - 0 (Hypoglycemic Agents)
SB  - IM
MH  - Male
MH  - Female
MH  - Humans
MH  - Insulin Glargine/adverse effects
MH  - *Diabetes Mellitus, Type 2/diagnosis/drug therapy
MH  - Insulin/adverse effects
MH  - Glycated Hemoglobin
MH  - Hypoglycemic Agents/adverse effects
MH  - *Hypoglycemia/chemically induced/epidemiology
MH  - Body Weight
MH  - *Insulin Resistance
OTO - NOTNLM
OT  - C-peptide
OT  - Clustering
OT  - Insulin glargine
OT  - Randomised clinical trial
OT  - Type 2 diabetes
COIS- Declaration of Competing Interest W.L. is an employee of Sanofi, Germany, and 
      Sanofi shareholder. G.B. is an IVIDATA employee, contracted to Sanofi. B.M.F. has 
      served on advisory panels for Eli Lilly and Zucara Therapeutics, and on the 
      speakers' bureau for Eli Lilly, Novo Nordisk, Sanofi, and Abbott. G.B.B. is a 
      consultant for Eli Lilly and Sanofi; has received research support from Sanofi; 
      and is on the speakers' bureau for Eli Lilly, Menarini, and Sanofi. D.R.O. has 
      received honoraria for lecturing and consulting from Boehringer Ingelheim, Eli 
      Lilly, Roche Diagnostics, Sanofi, and Takeda.
EDAT- 2023/05/05 00:42
MHDA- 2023/08/01 06:45
CRDT- 2023/05/04 22:00
PHST- 2023/01/17 00:00 [received]
PHST- 2023/04/13 00:00 [revised]
PHST- 2023/04/29 00:00 [accepted]
PHST- 2023/08/01 06:45 [medline]
PHST- 2023/05/05 00:42 [pubmed]
PHST- 2023/05/04 22:00 [entrez]
AID - S1751-9918(23)00093-1 [pii]
AID - 10.1016/j.pcd.2023.04.010 [doi]
PST - ppublish
SO  - Prim Care Diabetes. 2023 Aug;17(4):379-385. doi: 10.1016/j.pcd.2023.04.010. Epub 
      2023 May 2.