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Efficacy and safety of insulin glargine/lixisenatide (iGlarLixi) fixed-ratio combination in older adults with type 2 diabetes.
J Diabetes Complications. 2019 03; 33(3):236-242.JD

Abstract

AIMS

This study assessed the efficacy and safety of iGlarLixi (a titratable, fixed-ratio combination of insulin glargine [iGlar] plus lixisenatide) in older patients with type 2 diabetes.

METHODS

This post hoc analysis used patient-level data from patients aged ≥65 years from the phase III LixiLan-O and LixiLan-L studies, which compared iGlarLixi with iGlar and lixisenatide (LixiLan-O only). Efficacy endpoints were changes in glycated hemoglobin A1C, fasting plasma glucose, postprandial glucose, weight, and achievement of A1C <7.0% (53 mmol/mol). Safety measures included incidence of documented symptomatic hypoglycemia (defined as typical symptoms of hypoglycemia plus self-measured plasma glucose ≤70 mg/dL [3.9 mmol/L]), severe hypoglycemia (requiring assistance of another person), and incidence of gastrointestinal adverse events. Results were compared with those from patients aged <65 years.

RESULTS

In both trials, older patients treated with iGlarLixi achieved significantly greater reductions in A1C at Week 30 than comparators. Treatment with iGlarLixi mitigated insulin-associated weight gain and lixisenatide-associated gastrointestinal events. Results were largely comparable between patients aged ≥65 versus <65 years.

CONCLUSIONS

iGlarLixi provides significant improvements in glycemic control in patients aged ≥65 years without increasing hypoglycemia risk. As a once-daily injection, it simplifies treatment regimens and may contribute to improved adherence in this patient population.

Authors+Show Affiliations

Metabolic Institute of America, 18372 Clark St. Suite 212, Tarzana, CA 91356, USA. Electronic address: yhandelsman@gmail.com.Abington Memorial Hospital, 500 York Rd Suite 108, Jenkintown, PA 19046, USA. Electronic address: cchovane@gmail.com.Sanofi US, Inc., 55 Corporate Drive, Bridgewater, NJ 08807, USA. Electronic address: terry.dex@sanofi.com.University of Bari Aldo Moro, Piazza Giulio Cesare 11, Bari 70124, Italy. Electronic address: francesco.giorgino@uniba.it.Abington Memorial Hospital, 500 York Rd Suite 108, Jenkintown, PA 19046, USA. Electronic address: nskolnik@comcast.net.Sanofi, 1 Avenue Pierre Brossolette, 91380 Chilly-Mazarin, France. Electronic address: elisabeth.souhami@sanofi.com.Sanofi US, Inc., 55 Corporate Drive, Bridgewater, NJ 08807, USA. Electronic address: william-EXT.stager@sanofi.com.Sanofi Pasteur, K703, Industriepark Höchst, 65926 Frankfurt, Germany. Electronic address: elisabeth.niemoeller@sanofi.com.National Research Institute, 2010 Wilshire Blvd #302, Los Angeles, 90057, CA, USA. Electronic address: juan.frias@nritrials.com.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30600136

Citation

Handelsman, Yehuda, et al. "Efficacy and Safety of Insulin Glargine/lixisenatide (iGlarLixi) Fixed-ratio Combination in Older Adults With Type 2 Diabetes." Journal of Diabetes and Its Complications, vol. 33, no. 3, 2019, pp. 236-242.
Handelsman Y, Chovanes C, Dex T, et al. Efficacy and safety of insulin glargine/lixisenatide (iGlarLixi) fixed-ratio combination in older adults with type 2 diabetes. J Diabetes Complicat. 2019;33(3):236-242.
Handelsman, Y., Chovanes, C., Dex, T., Giorgino, F., Skolnik, N., Souhami, E., Stager, W., Niemoeller, E., & Frias, J. P. (2019). Efficacy and safety of insulin glargine/lixisenatide (iGlarLixi) fixed-ratio combination in older adults with type 2 diabetes. Journal of Diabetes and Its Complications, 33(3), 236-242. https://doi.org/10.1016/j.jdiacomp.2018.11.009
Handelsman Y, et al. Efficacy and Safety of Insulin Glargine/lixisenatide (iGlarLixi) Fixed-ratio Combination in Older Adults With Type 2 Diabetes. J Diabetes Complicat. 2019;33(3):236-242. PubMed PMID: 30600136.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of insulin glargine/lixisenatide (iGlarLixi) fixed-ratio combination in older adults with type 2 diabetes. AU - Handelsman,Yehuda, AU - Chovanes,Christina, AU - Dex,Terry, AU - Giorgino,Francesco, AU - Skolnik,Neil, AU - Souhami,Elisabeth, AU - Stager,William, AU - Niemoeller,Elisabeth, AU - Frias,Juan Pablo, Y1 - 2018/11/30/ PY - 2018/06/22/received PY - 2018/11/02/revised PY - 2018/11/23/accepted PY - 2019/1/3/pubmed PY - 2020/7/3/medline PY - 2019/1/3/entrez KW - Elderly KW - Fixed-ratio combination KW - Insulin glargine KW - Lixisenatide KW - Type 2 diabetes KW - iGlarLixi SP - 236 EP - 242 JF - Journal of diabetes and its complications JO - J. Diabetes Complicat. VL - 33 IS - 3 N2 - AIMS: This study assessed the efficacy and safety of iGlarLixi (a titratable, fixed-ratio combination of insulin glargine [iGlar] plus lixisenatide) in older patients with type 2 diabetes. METHODS: This post hoc analysis used patient-level data from patients aged ≥65 years from the phase III LixiLan-O and LixiLan-L studies, which compared iGlarLixi with iGlar and lixisenatide (LixiLan-O only). Efficacy endpoints were changes in glycated hemoglobin A1C, fasting plasma glucose, postprandial glucose, weight, and achievement of A1C <7.0% (53 mmol/mol). Safety measures included incidence of documented symptomatic hypoglycemia (defined as typical symptoms of hypoglycemia plus self-measured plasma glucose ≤70 mg/dL [3.9 mmol/L]), severe hypoglycemia (requiring assistance of another person), and incidence of gastrointestinal adverse events. Results were compared with those from patients aged <65 years. RESULTS: In both trials, older patients treated with iGlarLixi achieved significantly greater reductions in A1C at Week 30 than comparators. Treatment with iGlarLixi mitigated insulin-associated weight gain and lixisenatide-associated gastrointestinal events. Results were largely comparable between patients aged ≥65 versus <65 years. CONCLUSIONS: iGlarLixi provides significant improvements in glycemic control in patients aged ≥65 years without increasing hypoglycemia risk. As a once-daily injection, it simplifies treatment regimens and may contribute to improved adherence in this patient population. SN - 1873-460X UR - https://www.unboundmedicine.com/medline/citation/30600136/Efficacy_and_safety_of_insulin_glargine/lixisenatide__iGlarLixi__fixed_ratio_combination_in_older_adults_with_type_2_diabetes_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1056-8727(18)30601-9 DB - PRIME DP - Unbound Medicine ER -