<b>Objective</b>
<p><a>In the LixiLan-G trial, switching to
iGlarLixi, a once-daily titratable fixed-ratio combination of insulin glargine </a>100 units/mL and the glucagon-like peptide-1 receptor
agonist (GLP-1 RA) lixisenatide, improved glucose control in type 2 diabetes (T2D)
uncontrolled with GLP-1 RAs over 26 weeks versus continuing prior GLP-1 RA. A
prespecified, 26-week, single-arm extension of LixiLan-G aimed to determine the
durability of iGlarLixi efficacy and safety over 52 weeks. </p>
<p><b>Research Design and Methods</b></p>
<p>Participants with T2D uncontrolled by GLP-1 RAs (HbA<sub>1c</sub> 7–9 % [53–75 mmol/mol]) were initially randomized
to switch to iGlarLixi or continue prior GLP-1 RA. Those randomized to
iGlarLixi who completed the 26-week primary endpoint period could continue iGlarLixi
open-label treatment over a 26-week extension to assess durability of efficacy
and safety.</p>
<p><b>Results</b></p>
<p>Glycemic
control achieved with iGlarLixi at week 26 (mean HbA<sub>1c</sub> 6.7 % [50 mmol/mol])
was maintained at week 52 (mean HbA<sub>1c</sub> 6.7 % [50 mmol/mol]; mean ± standard
deviation change from baseline at week 52: −1.0 ± 0.9 % [11 ± 10 mmol/mol]). Proportions
of participants reaching HbA<sub>1c</sub> <7 % (53 mmol/mol) with iGlarLixi
were similar at week 26 (62%) and 52 (64%), as were those reaching this target
without documented symptomatic (<3.0 mmol/L) hypoglycemia (57% and 58%). Safety
of iGlarLixi was similar at weeks 26 and 52, with low rates of documented
symptomatic hypoglycemia and gastrointestinal events.</p>
<p><b>Conclusions</b></p>
The efficacy and
safety of iGlarLixi at the end of the 26-week randomized treatment period was
maintained over the 26-week extension period in the LixiLan-G trial.
Correction to: Efficacy and Safety of Luseogliflozin in Patients with Type 2 Diabetes Complicated by Hepatic Dysfunction: A Single-Site, Single-Arm, Open-Label, Exploratory Trial
