SEARCHCOHORTendocrinology, internal medicine

cohort·endocrinology, internal medicine, observational study, clinical nutrition·PMC10064361

Effectiveness and Safety of iGlarLixi (Insulin Glargine 100 U/mL Plus Lixisenatide) in Type 2 Diabetes According to the Timing of Daily Administration: Data from the REALI Pooled Analysis

Diabetes Therapy · 8 authors, 8 centres

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TL;DR

The central result found iGlarLixi was effective and safe regardless of administration time, but pre-breakfast injection resulted in numerically greater HbA1c reductions.

Full summary

577 CHARS

Participants were classified into four subgroups based on daily injection timing: pre-breakfast, pre-lunch, pre-dinner, and those who changed timing. The primary analysis used a mixed model for repeated measures to assess HbA1c change. Limitations include the relatively short treatment duration and potential for unmeasured confounding factors inherent to observational data. The findings support the flexibility of iGlarLixi administration timing, which can benefit patient adherence and lifestyle, though pre-breakfast timing may be preferable for optimal glycaemic control.

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cohort

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endocrinology

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ORIGINAL PAPER

PMC10064361

Effectiveness and Safety of iGlarLixi (Insulin Glargine 100 U/mL Plus Lixisenatide) in Type 2 Diabetes According to the Timing of Daily Administration: Data from the REALI Pooled Analysis

Diabetes Therapy

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ABSTRACT

Introduction iGlarLixi (insulin glargine 100 U/mL plus lixisenatide) has demonstrated glycaemic efficacy and safety in adults with inadequately controlled type 2 diabetes mellitus (T2DM). Per the European Medicines Agency’s product label, iGlarLixi should be injected once a day within 1 h prior to a meal, preferably the same meal every day when the most convenient meal has been chosen. It is however unknown whether iGlarLixi administration timing affects glycaemic control and safety, as clinical trial evidence is mainly based on pre-breakfast iGlarLixi administration. Therefore, we assessed the effectiveness and safety of iGlarLixi in clinical practice, according to its administration timing. Methods Data were pooled from two prospective observational studies including 1303 European participants with T2DM inadequately controlled on oral antidiabetic drugs with or without basal insulin who initiated iGlarLixi therapy for 24 weeks. Participants were classified into four subgroups based on daily timing of iGlarLixi injection: pre-breakfast ( N = 436), pre-lunch ( N = 262), pre-dinner ( N = 399), and those who switched iGlarLixi injection time during the study ( N = 206). Results No meaningful differences in baseline characteristics were observed between the study groups. Least-squares mean reductions in haemoglobin A1c (HbA1c) from baseline to week 24 were substantial in all groups, with the numerically largest decrease observed in the pre-breakfast group (1.57%) compared with the pre-lunch (1.27%), pre-dinner (1.42%), or changed injection time (1.33%) groups. Pre-breakfast iGlarLixi injection also resulted in a numerically greater proportion of participants achieving HbA1c < 7.0% at week 24 (33.7% versus 19.0% for pre-lunch, 25.6% pre-dinner, and 23.2% changed injection time). iGlarLixi was well tolerated across all groups, with low rates of gastrointestinal disorders and hypoglycaemia. Mean body weight decreased similarly in all groups (by 1.3–2.3 kg). Conclusion iGlarLixi was effective and safe regardless of its daily administration time. However, pre-breakfast iGlarLixi injection resulted in a more effective glycaemic control. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-023-01375-8.

CITATION EXPORT

Martin Haluzík, Jochen Seufert, Cristian Guja et al.. Effectiveness and Safety of iGlarLixi (Insulin Glargine 100 U/mL Plus Lixisenatide) in Type 2 Diabetes According to the Timing of Daily Administration: Data from the REALI Pooled Analysis. Diabetes Therapy. (2023). https://doi.org/10.1007/s13300-023-01375-8

AUTHORS

8 · 8 CENTRES

Martin Haluzík, Jochen Seufert, Cristian Guja, Mireille Bonnemaire, Gregory Bigot, Mathilde Tournay, János Tibor Kis, Nick Freemantle

1grid.418930.70000 0001 2299 1368Institute for Clinical and Experimental Medicine and Charles University, Prague, Czech Republic
2grid.5963.9Division of Endocrinology and Diabetology, Department of Medicine II, Medical Centre-Faculty of Medicine, University of Freiburg, Freiburg, Germany
3grid.8194.40000 0000 9828 7548Department of Diabetes, Nutrition and Metabolic Diseases, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania
4grid.417924.dGeneral Medicines, Sanofi, Paris, France
5IVIDATA Group, Paris, France
6grid.482598.aInternational Drug Development Institute (IDDI), Louvain-la-Neuve, Belgium
7grid.414806.f0000 0004 0594 2929Department of Internal Medicine Centrum, Szent János Hospital, Budapest, Hungary
8grid.83440.3b0000000121901201Institute of Clinical Trials and Methodology, University College London, London, UK