INTRODUCTION: This study aimed to evaluate the effect of baseline body mass index (BMI) and glycated hemoglobin (HbA1c) on the effectiveness and safety of initiating iGlarLixi (insulin glargine 100 U/ml and lixisenatide) in people with type 2 diabetes (T2D) in routine clinical practice. METHODS: We pooled patient-level data from 1406 people with inadequately controlled T2D, initiating a 24-week iGlarLixi treatment. Analysis sets were based on baseline BMI and HbA1c. In the BMI set, 894 (64%) people had a BMI ≥ 30 kg/m2 and 510 (36%) a BMI < 30 kg/m2; in the HbA1c set, 615 (44%) people had an HbA1c >9%, 491 (35%) between 8 and 9%, and 298 (21%) < 8%. RESULTS: After initiating iGlarLixi, HbA1c decreased in all participants, with the greatest least-squares mean reduction at 2.15% from baseline to week 24 in those with baseline HbA1c > 9% (using a mixed model for repeated measures). Overall, mean ± standard deviation body weight decreased by 1.9 ± 4.8 kg, with the most prominent loss of 2.6 ± 4.9 kg recorded in people presenting with obesity. Reported hypoglycemia rates were low across all groups. CONCLUSIONS: Initiation of iGlarLixi in people with uncontrolled T2D is effective and safe in clinical practice, across different baseline HbA1c and BMI categories.

Department of Diabetes Nutrition and Metabolic Diseases Carol Davila University of Medicine and Pharmacy Bucharest Romania

Department of Internal Medicine Centrum Szent János Hospital Budapest Hungary

Diabetes Centre Institute for Clinical and Experimental Medicine and Charles University Prague Czech Republic

Division of Endocrinology and Diabetology Department of Medicine 2 Medical Center University of Freiburg Freiburg Germany

General Medicines Sanofi Paris France

Institute of Clinical Trials and Methodology University College London London UK

International Drug Development Institute Louvain la Neuve Belgium

Ividata Life Sciences Levallois Perret France

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Achila OO, Ghebretinsae M, Kidane A, Simon M, Makonen S, Rezene Y. Factors associated with poor glycemic and lipid levels in ambulatory diabetes mellitus type 2 patients in Asmara, Eritrea: a cross-sectional study. J Diabetes Res. 2020;2020:5901569. PubMed PMC

Fang M, Wang D, Coresh J, Selvin E. Trends in diabetes treatment and control in U.S. adults, 1999–2018. N Engl J Med. 2021;384(23):2219–28. PubMed PMC

Rakhis SA, AlDuwayhis NM, Aleid N, AlBarrak AN, Aloraini AA. Glycemic control for type 2 diabetes mellitus patients: a systematic review. Cureus. 2022;14(6): e26180. PubMed PMC

Taybani Z, Bótyik B, Katkó M, Gyimesi A, Várkonyi T. Simplifying complex insulin regimens while preserving good glycemic control in type 2 diabetes. Diabetes Ther. 2019;10(5):1869–78. PubMed PMC

American Diabetes Association Professional Practice Committee. Pharmacologic approaches to glycemic treatment Standards of Care in Diabetes 2024. Diabetes Care. 2024;47(Suppl 1):S158–78. PubMed PMC

Skolnik N, Del Prato S, Blonde L, Galstyan G, Rosenstock J. Translating iGlarLixi evidence for the management of frequent clinical scenarios in type 2 diabetes. Adv Ther. 2021;38(4):1715–31. PubMed PMC

Blonde L, Rosenstock J, Del Prato S, et al. Switching to iGlarLixi versus continuing daily or weekly GLP-1 RA in type 2 diabetes inadequately controlled by GLP-1 RA and oral antihyperglycemic therapy: the LixiLan-G randomized clinical trial. Diabetes Care. 2019;42(11):2108–16. PubMed

Aroda VR, Rosenstock J, Wysham C, et al. Efficacy and safety of LixiLan, a titratable fixed-ratio combination of insulin glargine plus lixisenatide in type 2 diabetes inadequately controlled on basal insulin and metformin: the LixiLan-L randomized trial. Diabetes Care. 2016;39(11):1972–80. PubMed

Rosenstock J, Aronson R, Grunberger G, et al. Benefits of LixiLan, a titratable fixed-ratio combination of insulin glargine plus lixisenatide, versus insulin glargine and lixisenatide monocomponents in type 2 diabetes inadequately controlled on oral agents: the LixiLan-O randomized trial. Diabetes Care. 2016;39(11):2026–35. PubMed

Wysham C, Bonadonna RC, Aroda VR, et al. Consistent findings in glycaemic control, body weight and hypoglycaemia with iGlarLixi (insulin glargine/lixisenatide titratable fixed-ratio combination) vs insulin glargine across baseline HbA1c, BMI and diabetes duration categories in the LixiLan-L trial. Diabetes Obes Metab. 2017;19(10):1408–15. PubMed PMC

Davies MJ, Leiter LA, Guerci B, et al. Impact of baseline glycated haemoglobin, diabetes duration and body mass index on clinical outcomes in the LixiLan-O trial testing a titratable fixed-ratio combination of insulin glargine/lixisenatide (iGlarLixi) vs insulin glargine and lixisenatide monocomponents. Diabetes Obes Metab. 2017;19(12):1798–804. PubMed PMC

Davies MJ, Aroda VR, Collins BS, et al. Management of hyperglycemia in type 2 diabetes, 2022 A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022;45(11):2753–86. PubMed PMC

Guja C, Kis JT, Haluzík M, et al. iGlarLixi (insulin glargine 100 U/ml plus lixisenatide) is effective and well tolerated in people with uncontrolled type 2 diabetes regardless of age: A REALI pooled analysis of prospective real-world data. Diabetes Obes Metab. 2023;25(6):1723–30. PubMed

Seufert J, Freemantle N, Guja C, et al. Real-life effectiveness of iGlarLixi (insulin glargine 100 U/ml and lixisenatide) in people with type 2 diabetes according to prior insulin use. Diabetes Obes Metab. 2024;26(7):2988–92. PubMed

Kis JT, Nagy G, Kovacs G. Effectiveness of iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/ml and lixisenatide, in people with type 2 diabetes. Diabetes Ther. 2021;12(9):2517–29. PubMed PMC

Bala C, Cerghizan A, Mihai BM, Moise M, Guja C. Real-world evidence on the use of a fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) in people with suboptimally controlled type 2 diabetes in Romania: a prospective cohort study (STAR.Ro). BMJ Open. 2022;12(5): e060852. PubMed PMC

Weisner T, Pfohl M, Pegelow K, Muller J, Seufert J. Effectiveness and safety of iGlarLixi in people with type 2 diabetes (PwT2D), Not at target on basal insulin (BI) and oral antidiabetic therapy (BOT)—Results from the Observational, Prospective Study CHANCE. Poster 794-P in American Diabetes Association (ADA). 2023; https://eacademy.sanofi.de/s3fs-public/pdf/64df5e266881e313628072.pdf

Bonadonna RC, Mauricio D, Müller-Wieland D, et al. Impact of age on the effectiveness and safety of insulin glargine 300 U/ml: results from the REALI European pooled data analysis. Diabetes Ther. 2021;12(4):1073–97. PubMed PMC

Gourdy P, Bonadonna RC, Freemantle N, et al. Does gender influence the effectiveness and safety of insulin glargine 300 U/ml in patients with uncontrolled type 2 diabetes? Results from the REALI European pooled analysis. Diabetes Ther. 2022;13(1):57–73. PubMed PMC

Müller-Wieland D, Freemantle N, Bonadonna RC, et al. Glycaemic control in people with type 2 diabetes mellitus switching from basal insulin to insulin glargine 300 U/ml (Gla-300): results from the REALI pooled database. Diabetes Ther. 2023;14(2):401–13. PubMed PMC

Haluzík M, Seufert J, Guja C, 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 Ther. 2023;14(4):639–52. PubMed PMC

Freemantle N, Bonadonna RC, Gourdy P, et al. Rationale and methodology for a European pooled analysis of postmarketing interventional and observational studies of insulin glargine 300 U/ml in diabetes: protocol of REALI project. BMJ Open. 2020;10(4): e033659. PubMed PMC

European Medicines Agency. Suliqua: EPAR - Product information. 2023; Available from: https://www.ema.europa.eu/en/documents/product-information/suliqua-epar-product-information_en.pdf

Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013;36(5):1384–95. PubMed PMC

Szépkúti S, Bandur S, Kovács G, et al. Real-world effectiveness of IDegLira compared with intensified conventional insulin therapy in adults with type 2 diabetes: a retrospective cohort study. BMC Endocr Disord. 2022;22(1):229. PubMed PMC

Price H, Blüher M, Prager R, et al. Use and effectiveness of a fixed-ratio combination of insulin degludec/liraglutide (IDegLira) in a real-world population with type 2 diabetes: results from a European, multicentre, retrospective chart review study. Diabetes Obes Metab. 2018;20(4):954–62. PubMed PMC

Zenari L, Da Porto A, De Moliner L, et al. Real-world evaluation of glycemic outcomes and extra-glycemic parameters in diabetic patients treated with the combined formulation degludec-liraglutide (IDegLira). Diabetes Ther. 2021;12(1):197–209. PubMed PMC