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ABSTRACT: Aim
To investigate the impact of renal function on the safety and efficacy of insulin glargine 300?U/mL (Gla-300) and insulin glargine 100?U/mL (Gla-100).Materials and methods
A meta-analysis was performed using pooled 6-month data from the EDITION 1, 2 and 3 trials (N?=?2496). Eligible participants, aged ?18?years with a diagnosis of type 2 diabetes (T2DM), were randomized to receive once-daily evening injections of Gla-300 or Gla-100. Pooled results were assessed by two renal function subgroups: estimated glomerular filtration rate (eGFR) <60 and ?60?mL/min/1.73?m2 .Results
The decrease in glycated haemoglobin (HbA1c) after 6?months and the proportion of individuals with T2DM achieving HbA1c targets were similar in the Gla-300 and Gla-100 groups, for both renal function subgroups. There was a reduced risk of nocturnal (12:00-5:59 am) confirmed (?3.9?mmol/L [?70?mg/dL]) or severe hypoglycaemia with Gla-300 in both renal function subgroups (eGFR <60?mL/min/1.73?m2 : relative risk [RR] 0.76 [95% confidence interval {CI} 0.62-0.94] and eGFR ?60?mL/min/1.73?m2 : RR 0.75 [95% CI 0.67-0.85]). For confirmed (?70?mg/dL [?3.9?mmol/L]) or severe hypoglycaemia at any time of day (24?hours) the hypoglycaemia risk was lower with Gla-300 vs Gla-100 in both the lower (RR 0.94 [95% CI 0.86-1.03]) and higher (RR 0.90 [95% CI 0.85-0.95]) eGFR subgroups.Conclusions
Gla-300 provided similar glycaemic control to Gla-100, while indicating a reduced overall risk of confirmed (?3.9 and <3.0?mmol/L [?70 and <54?mg/dL]) or severe hypoglycaemia, with no significant difference between renal function subgroups.
SUBMITTER: Javier Escalada F
PROVIDER: S-EPMC6282564 | biostudies-literature | 2018 Dec
REPOSITORIES: biostudies-literature
Javier Escalada F F Halimi Serge S Senior Peter A PA Bonnemaire Mireille M Cali Anna M G AMG Melas-Melt Lydie L Karalliedde Janaka J Ritzel Robert A RA
Diabetes, obesity & metabolism 20180830 12
<h4>Aim</h4>To investigate the impact of renal function on the safety and efficacy of insulin glargine 300 U/mL (Gla-300) and insulin glargine 100 U/mL (Gla-100).<h4>Materials and methods</h4>A meta-analysis was performed using pooled 6-month data from the EDITION 1, 2 and 3 trials (N = 2496). Eligible participants, aged ≥18 years with a diagnosis of type 2 diabetes (T2DM), were randomized to receive once-daily evening injections of Gla-300 or Gla-100. Pooled results were assessed by two renal f ...[more]