PMID- 33650085
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210417
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 12
IP  - 4
DP  - 2021 Apr
TI  - Impact of Age on the Effectiveness and Safety of Insulin Glargine 300 U/mL: 
      Results from the REALI European Pooled Data Analysis.
PG  - 1073-1097
LID - 10.1007/s13300-021-01030-0 [doi]
AB  - INTRODUCTION: Patients aged >/= 65 years continue to be underrepresented in 
      clinical studies related to type 2 diabetes mellitus (T2DM). Accordingly, the 
      REALI pooled analysis was performed to evaluate the effectiveness and safety of 
      insulin glargine 300 U/mL (Gla-300) across different age subgroups, using data 
      from 14 interventional and non-interventional studies. METHODS: Pooled efficacy 
      and safety data were collected from 8106 European patients with uncontrolled T2DM 
      who were initiated on or switched to Gla-300 injected once daily for 24 weeks. 
      Patients were categorised into five age subgroups: < 50 (N = 727), 50-59 
      (N = 2030), 60-69 (N = 3054), 70-79 (N = 1847) and >/= 80 years (N = 448). RESULTS: 
      Mean baseline haemoglobin A1c (HbA1c) decreased linearly from the youngest 
      (9.10%) to the oldest (8.46%) age subgroup. Following Gla-300 initiation, there 
      were similar HbA1c reductions across age groups, with a least squares mean (95% 
      confidence interval) change in HbA1c from baseline to week 24 of - 1.09% (- 1.18 
      to - 1.00), - 1.08% (- 1.14 to - 1.03), - 1.12% (- 1.17 to - 1.07), - 1.18% 
      (- 1.24 to - 1.12) and - 1.11% (- 1.23 to - 0.99) in the < 50, 50-59, 60-69, 
      70-79 and >/= 80 years subgroups, respectively. The incidences and event rates of 
      reported hypoglycaemia were overall low. Compared to younger age subgroups, lower 
      incidences of symptomatic hypoglycaemia occurring at any time of the day (5.9 vs. 
      7.6-9.4% for the younger subgroups) or during the night (0.5 vs. 1.6-2.5%) were 
      recorded in patients aged >/= 80 years. By contrast, the highest incidence of 
      severe hypoglycaemia occurring any time of the day was reported in the subgroup 
      aged >/= 80 years (1.1 vs. 0.1-0.6% for the younger age subgroups). CONCLUSION: 
      Gla-300 initiated in patients with uncontrolled T2DM provides glycaemic 
      improvement with a favourable safety profile across a wide range of ages.
FAU - Bonadonna, Riccardo C
AU  - Bonadonna RC
AD  - Azienda Ospedaliero-Universitaria di Parma, Parma, Italy. 
      riccardo.bonadonna@unipr.it.
AD  - Department of Medicine and Surgery, University of Parma, Parma, Italy. 
      riccardo.bonadonna@unipr.it.
FAU - Mauricio, Didac
AU  - Mauricio D
AD  - Department of Endocrinology and Nutrition, CIBERDEM, Institut de Recerca Hospital 
      de la Santa Creu i Sant Pau, Barcelona, Spain.
FAU - Muller-Wieland, Dirk
AU  - Muller-Wieland D
AD  - Department of Medicine I, University Hospital Aachen, Aachen, Germany.
FAU - Freemantle, Nick
AU  - Freemantle N
AD  - Institute of Clinical Trials and Methodology, University College London, London, 
      UK.
FAU - Bigot, Gregory
AU  - Bigot G
AD  - IVIDATA Group, Paris, France.
FAU - Mauquoi, Celine
AU  - Mauquoi C
AD  - International Drug Development Institute (IDDI), Louvain-la-Neuve, Belgium.
FAU - Ciocca, Alice
AU  - Ciocca A
AD  - General Medicines, Sanofi, Paris, France.
FAU - Bonnemaire, Mireille
AU  - Bonnemaire M
AD  - General Medicines, Sanofi, Paris, France.
FAU - Gourdy, Pierre
AU  - Gourdy P
AD  - Endocrinology, Diabetology and Nutrition Department, Toulouse University 
      Hospital, Toulouse, France.
AD  - Institute of Metabolic and Cardiovascular Diseases, UMR1048 INSERM/UPS, Toulouse 
      University, Toulouse, France.
LA  - eng
PT  - Journal Article
DEP - 20210301
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC7994463
OTO - NOTNLM
OT  - Age
OT  - Europe
OT  - Glycaemic control
OT  - Hypoglycaemia
OT  - Insulin glargine 300 U/mL
OT  - Older adults
OT  - Pooled analysis
OT  - Type 2 diabetes
EDAT- 2021/03/03 06:00
MHDA- 2021/03/03 06:01
PMCR- 2021/03/01
CRDT- 2021/03/02 06:23
PHST- 2021/01/12 00:00 [received]
PHST- 2021/02/10 00:00 [accepted]
PHST- 2021/03/03 06:00 [pubmed]
PHST- 2021/03/03 06:01 [medline]
PHST- 2021/03/02 06:23 [entrez]
PHST- 2021/03/01 00:00 [pmc-release]
AID - 10.1007/s13300-021-01030-0 [pii]
AID - 1030 [pii]
AID - 10.1007/s13300-021-01030-0 [doi]
PST - ppublish
SO  - Diabetes Ther. 2021 Apr;12(4):1073-1097. doi: 10.1007/s13300-021-01030-0. Epub 
      2021 Mar 1.