Efficacy and safety of insulin glargine/lixisenatide (iGlarLixi) fixed-ratio combination in older adults with type 2 diabetes

Handelsman, Yehuda; Chovanes, Christina; Dex, Terry; Giorgino, Francesco; Skolnik, Neil; Souhami, Elisabeth; Stager, William; Niemoeller, Elisabeth; Frías, Juan P.

doi:10.1016/j.jdiacomp.2018.11.009

Cited by 19 publications

(27 citation statements)

References 25 publications

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“…The efficacy and safety of iGlarLixi was assessed in patients ≥ 65 versus < 65 years of age in an analysis using patient-level data from the LixiLan-O and LixiLan-L studies [111]. In both studies, more patients who received iGlarLixi versus iGlar or lixisenatide reached the HbA1c target of < 7%, and the results were similar for older (≥ 65 years) and younger (< 65 years) patients, although the absolute percentages were lower in the LixiLan-L study compared with the LixiLan-O study.…”

Section: Use Of Iglarlixi In Older Adults With T2dmentioning

confidence: 99%

Combining GLP-1 Receptor Agonists and Basal Insulin in Older Adults with Type 2 Diabetes: Focus on Lixisenatide and Insulin Glargine

2019

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Estimates suggest that there are currently 122.8 million adults 65-99 years of age living with diabetes, of whom 90-95% are diagnosed with type 2 diabetes (T2D). Over the past two decades, a greater understanding of the complex and multifactorial pathogenesis of T2D has resulted in the development and introduction of new-generation classes of glucose-lowering therapies, which are now extensively endorsed by prevailing guidelines and are increasingly being used worldwide. These newer agents may further assist in the effective pharmacological management of T2D through the provision of patient-centered care that acknowledges multimorbidity and is respectful of and responsive to individual patient preferences and barriers. Given these considerations, the therapeutic approach in older patients with T2D is complex, particularly in those who have functional dependence, frailty, dementia, or who are at end-of-life. It is currently too early to draw conclusions on the long-term use of newer glucose-lowering agents in this population, as their efficacy and safety in older adults remains largely unknown. In this review, we will discuss considerations for the use of glucose-lowering treatments in older adults, with particular focus on the use of basal insulin and glucagon-like peptide-1 receptor agonists, and the rationale for the use of combination therapy comprising these agents. Finally, we will review clinical data from studies of the fixed-ratio combination of insulin glargine and lixisenatide in older patients with T2D.

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Section: Use Of Iglarlixi In Older Adults With T2dmentioning

confidence: 99%

Combining GLP-1 Receptor Agonists and Basal Insulin in Older Adults with Type 2 Diabetes: Focus on Lixisenatide and Insulin Glargine

2019

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“…In older patients (≥ 65 years), a post hoc analysis of data from the LixiLan-L and LixiLan-O trials showed that iGlarLixi was associated with no increased risk of hypoglycemia when compared with insulin glargine. Modest weight loss was observed in iGlarLixi-treated older patients in both the LixiLan-L ( P = 0.007) and LixiLan-O ( P = 0.017) trials [ 46 ]. Of the 834 patients in the LixiLan studies who received iGlarLixi, 25.2% ( n = 210) were at least 65 years of age and 4% ( n = 33) were at least 75 years of age.…”

Section: Resultsmentioning

confidence: 99%

A Review of the Safety and Adverse Event Profile of the Fixed-Ratio Combination of Insulin Glargine and Lixisenatide

et al. 2018

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IntroductioniGlarLixi is a titratable, fixed-ratio combination of insulin glargine (100 units/mL) and lixisenatide (33 μg/mL). This review evaluates the overall safety and adverse event (AE) profile of iGlarLixi in patients with type 2 diabetes.MethodsWe collated patient-level data from the phase 2 LixiLan proof-of-concept trial and the phase 3 LixiLan-L (insulin-experienced patients) and LixiLan-O (insulin-naïve patients) trials to evaluate AEs associated with iGlarLixi. We also describe data from the ELIXA study to examine pancreatitis and pancreatic cancer, and the ELIXA and ORIGIN studies for cardiovascular safety data.ResultsPatients treated with iGlarLixi had improved glycemic control with a similar incidence of documented symptomatic hypoglycemia (plasma glucose ≤ 70 mg/dL) compared with iGlar. Incidence of severe hypoglycemia (an event requiring third-party assistance) was low in all treatment arms in both LixiLan-L and LixiLan-O. Rates of gastrointestinal AEs in patients treated with iGlarLixi tended to be lower compared with lixisenatide alone, but higher than those treated with iGlar alone. Gastrointestinal AEs were generally mild to moderate in intensity and transient. Antibodies formed in response to iGlarLixi did not have any significant clinical impact, with similar safety observed for antibody-positive and antibody-negative populations. Rates of allergic reactions, malignancy, renal impairment, and cardiovascular events were low and comparable between treatment groups. Older age (≥ 65 years) and gender did not affect efficacy or safety.ConclusioniGlarLixi has a safety profile that is consistent with that of its two active components insulin glargine and lixisenatide, with no signals for pancreatitis or thyroid C cell tumors, and no black-box warning for iGlarLixi. There were no unexpected safety findings; iGlarLixi had beneficial effects on glycemic control, with no increased risk of hypoglycemia, despite a greater glycated hemoglobin A1c reduction. In addition, there were also fewer gastrointestinal AEs associated with iGlarLixi compared with lixisenatide alone.FundingSanofi US Inc.

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“…Hypoglycemia was defined as symptomatic documented plasma glucose < 70 mg/dl. age-based analysis found that iGlarLixi effectively reduced the extent of weight gain associated with insulin and GI AEs associated with Lixi, with similar results in patients aged !65 and <65 years [38].…”

Section: Post-hoc Analysesmentioning

confidence: 99%

Titratable fixed-ratio combination of insulin glargine plus lixisenatide: A simplified approach to glycemic control in type 2 diabetes mellitus

Giorgino

Genchi

Napoli

2020

Diabetes Research and Clinical Practice

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Approximately 50% of patients with type 2 diabetes mellitus (T2DM) do not achieve glycemic targets and require treatment intensification. A fixed-ratio combination of a glucagonlike peptide-1 receptor agonist (GLP-1 RA) with basal insulin, such as lixisenatide with insulin glargine (iGlarLixi), exploits the complementary mechanisms of action of each component to address hyperglycemia while mitigating potential adverse events (AEs). The iGlarLixi dose is titrated considering the effect of basal insulin on fasting plasma glucose, and the fixed-ratio combination ensures that the lixisenatide dose never exceeds 20 lg/day. We describe the characteristics of iGlarLixi therapy, based on the LixiLan clinical program, and provide guidance on the characteristics of patients likely to benefit from such treatment in routine clinical practice. In the phase III LixiLan trials, iGlarLixi resulted in significantly greater reductions in glycated hemoglobin (HbA1c), better achievement of HbA1c targets, less glycemic variability versus insulin glargine, lixisenatide or GLP-1 RA alone, and was associated with weight control, less hypoglycemia versus insulin glargine, and fewer GI AEs versus lixisenatide. Findings were consistent regardless of age, diabetes duration, and baseline HbA1c. The efficacy, safety, and convenient once-daily administration schedule of iGlarLixi make it a valuable treatment option for patients with T2DM requiring treatment intensification.

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Efficacy and safety of insulin glargine/lixisenatide (iGlarLixi) fixed-ratio combination in older adults with type 2 diabetes

Cited by 19 publications

References 25 publications

Combining GLP-1 Receptor Agonists and Basal Insulin in Older Adults with Type 2 Diabetes: Focus on Lixisenatide and Insulin Glargine

Combining GLP-1 Receptor Agonists and Basal Insulin in Older Adults with Type 2 Diabetes: Focus on Lixisenatide and Insulin Glargine

A Review of the Safety and Adverse Event Profile of the Fixed-Ratio Combination of Insulin Glargine and Lixisenatide

Titratable fixed-ratio combination of insulin glargine plus lixisenatide: A simplified approach to glycemic control in type 2 diabetes mellitus

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