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. 2021 Jun;23(6):1331-1341.
doi: 10.1111/dom.14345. Epub 2021 May 4.

Switching to iGlarLixi versus continuation of a daily or weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) in insufficiently controlled type 2 diabetes: A LixiLan-G trial subgroup analysis by HbA1c and GLP-1 RA use at screening

Julio Rosenstock  1 , Lawrence Blonde  2 , Vanita R Aroda  3 , Juan Frias  4 , Elisabeth Souhami  5 , Chen Ji  6 , Elisabeth Niemoeller  7 , Stefano Del Prato  8
Affiliations

Switching to iGlarLixi versus continuation of a daily or weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) in insufficiently controlled type 2 diabetes: A LixiLan-G trial subgroup analysis by HbA1c and GLP-1 RA use at screening

Julio Rosenstock et al. Diabetes Obes Metab. 2021 Jun.

Abstract

Aim: In people with type 2 diabetes (T2D) requiring intensification beyond glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and oral antihyperglycaemic drugs (OADs), switching to iGlarLixi was shown to be efficacious and well-tolerated in the LixiLan-G trial. This exploratory analysis of LixiLan-G assessed the efficacy and safety of switching to iGlarLixi versus continuing GLP-1 RA therapy, stratified by screening HbA1c level (≥7.0 to ≤7.5 %; >7.5 to ≤8.0 %; >8.0 to ≤9.0 % [≥53 to ≤58 mmol/mol; >58 to ≤64 mmol/mol; >64 to ≤75 mmol/mol]) and previous GLP-1 RA regimen at screening (once/twice daily or once weekly).

Materials and methods: Endpoints for all subgroups included: change in HbA1c, achievement of HbA1c <7 % and hypoglycaemia events. Adverse events and changes in fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG), 2-hour PPG excursion and weight were analysed according to previous GLP-1 RA regimen.

Results: Switching to iGlarLixi in all subgroups resulted in significantly greater reductions in HbA1c and proportions of participants reaching HbA1c <7 % (including with no documented hypoglycaemia) at Week 26 compared with continued GLP-1 RA treatment. Switching to iGlarLixi also led to significantly greater reductions in FPG, 2-hour PPG, and 2-hour PPG excursion, irrespective of previous GLP-1 RA regimen. Rates of hypoglycaemia were low, but slightly higher in those who switched to iGlarLixi for all subgroups. Modest weight gain was seen with iGlarLixi, irrespective of previous GLP-1 RA regimen.

Conclusions: Switching to iGlarLixi improved glycaemic control, regardless of screening HbA1c or previous GLP-1 RA type, offering a simple, efficacious and well-tolerated treatment intensification option for people with T2D inadequately controlled by GLP-1 RAs and OADs.

Keywords: GLP-1 analogue; basal insulin; glycaemic control; incretin therapy; insulin therapy; type 2 diabetes.

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Conflict of interest statement

J.R. has been a consultant for Applied Therapeutics, Boehringer Ingelheim, Eli Lilly, Intarcia, Janssen, Novo Nordisk, Oramed and Sanofi, and has received grant/research support from Applied Therapeutics, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Genentech, GlaxoSmithKline, Intarcia, Janssen, Lexicon, Merck, Novo Nordisk, Oramed, Pfizer and Sanofi. L.B. has been a consultant for AstraZeneca, Gilead Sciences, Janssen, Merck, Novo Nordisk and Sanofi, has received grant/research support (including to his institution) from Janssen, Lexicon, Merck, Novo Nordisk and Sanofi, and has been a speaker for Janssen, Novo Nordisk and Sanofi. V.R.A. has received clinical trial/research support from Applied Therapeutics, Fractyl/Premier, Novo Nordisk and Sanofi, has been a consultant for Applied Therapeutics, Novo Nordisk and Sanofi, and her spouse is an employee of Janssen. J.F. has been a consultant for Boehringer Ingelheim, Johnson & Johnson, Eli Lilly, Merck, Novo Nordisk and Sanofi, has received grant/research support from AstraZeneca, Boehringer Ingelheim, Bristol‐Myers Squibb, Eli Lilly, Johnson & Johnson, Merck, Novo Nordisk, Pfizer, Sanofi and Theracos, and has been a speaker for Merck and Sanofi. E.S., C.J. and E.N. are employees of Sanofi. S.D.P. has received grant/research support from AstraZeneca, Boehringer Ingelheim, Merck and Novartis, and honoraria from Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Merck, Mundipharma, Novartis, Novo Nordisk, Sanofi, Servier and Takeda.

Figures

FIGURE 1
FIGURE 1
Change in mean glycated haemoglobin (HbA1c) (A) from screening to week 26 by HbA1c subgroup and (B) from baseline to Week 26 by previous glucagon‐like peptide‐1 receptor agonist (GLP‐1 RA) regimen subgroups in the modified intention‐to‐treat (mITT) population (mixed model repeated measures). ΔHbA1c indicates least squares (LS) mean change from (A) screening to Week 26 or (B) baseline to Week 26. Abbreviations: BID, twice daily; QD, once daily; QW, once weekly; SE, standard error
FIGURE 2
FIGURE 2
(A) Glycated haemoglobin (HbA1c) target (<7 %) achievement, and (B) HbA1c target (<7 %) achievement with no documented symptomatic hypoglycaemia (<3.0 mmol/L [<54 mg/dL]) over the 26‐week treatment period by screening HbA1c and previous glucagon‐like peptide 1 receptor agonist (GLP‐1 RA) regimen subgroup, modified intention‐to‐treat population. Abbreviations: BID, twice daily; QD, once daily; QW, once weekly
FIGURE 3
FIGURE 3
Mean change from baseline to Week 26 in (A) fasting plasma glucose (FPG), (B) 2‐hour postprandial plasma glucose (PPG), (C) 2‐hour PPG excursion, and (D) body weight by previous glucagon‐like peptide 1 receptor agonist (GLP‐1 RA) regimen subgroup, modified intention‐to‐treat population (mixed model repeated measures). Abbreviations: BID, twice daily; LS, least squares; QD, once daily; QW, once weekly; SE, standard error
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