Impact of baseline glycated haemoglobin, diabetes duration and body mass index on clinical outcomes in the <scp>LixiLan‐O</scp> trial testing a titratable fixed‐ratio combination of insulin glargine/lixisenatide (<scp>iGlarLixi</scp>) vs insulin glargine and lixisenatide monocomponents

Davies, Melanie J.; Leiter, Lawrence A.; Guerci, Bruno; Grunberger, George; Ampudia‐Blasco, Francisco Javier; Yu, Christine; Stager, William; Niemoeller, Elisabeth; Souhami, Elisabeth; Rosenstock, Julio

doi:10.1111/dom.12980

Cited by 23 publications

(29 citation statements)

References 11 publications

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“…The findings of the subgroup analyses in the Japanese population are consistent with those of the global LixiLan trials, 33 which found that iGlarLixi was effective across key baseline subgroups, including populations that may be challenging to treat (e.g., elderly people and those with high baseline BMI).…”

Section: T a B L E 3 Hba1c And Hypoglycaemia Outcomes By Baseline Hba1csupporting

confidence: 79%

Benefits of the fixed‐ratio combination of insulin glargine 100 units/mL and lixisenatide (iGlarLixi) in Japanese people with type 2 diabetes: A subgroup and time‐to‐control analysis of the LixiLan JP phase 3 trials

Terauchi

Yabe

Kaneto

et al. 2020

Diabetes Obesity Metabolism

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Aims To explore the impact of baseline characteristics on clinical outcomes in the phase 3 LixiLan JP trials which evaluated the efficacy and safety of iGlarLixi, a titratable fixed‐ratio combination of insulin glargine 100 units/mL (iGlar) and GLP‐1 RA lixisenatide (Lixi), vs Lixi (JP‐O1, NCT02749890) or iGlar (LixiLan JP‐O2, NCT02752828; JP‐L, NCT02752412) in Japanese people with type 2 diabetes uncontrolled on oral antidiabetes drugs (OADs; JP‐O1, JP‐O2) or OADs and basal insulin (JP‐L). Materials and methods Glycated haemoglobin (HbA1c) change from baseline to week 26 was assessed within patient subgroups. Subgroups were defined by dipeptidyl peptidase‐4 inhibitor use at screening (JP‐O1, JP‐O2 only), baseline HbA1c (<8%, ≥8%), baseline BMI (<25, ≥25 kg/m2) and age (<65, ≥65 years). Incidences of hypoglycaemia (baseline HbA1c, BMI and age subgroups) and gastrointestinal disorders (age subgroup) were evaluated over 52 (JP‐O1) or 26 weeks (JP‐O2, JP‐L). Time to control (first HbA1c <7% or fasting plasma glucose [FPG] ≤130 mg/dL; JP‐O2 only) was also assessed. Results HbA1c reductions were consistently greater with iGlarLixi vs iGlar or Lixi across all subgroups, and iGlarLixi was equally effective in all subgroups. Incidences of documented symptomatic hypoglycaemia (plasma glucose ≤3.9 mmol/L) were higher with iGlarLixi vs Lixi and generally comparable with iGlar. Across age subgroups, incidences of gastrointestinal disorders with iGlarLixi were higher vs iGlar, but lower vs Lixi. Median time to HbA1c or FPG control was shorter with iGlarLixi vs iGlar. Conclusions iGlarLixi was consistently effective across all baseline characteristic subgroups, with more patients achieving glycaemic control vs iGlar early in treatment.

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Section: T a B L E 3 Hba1c And Hypoglycaemia Outcomes By Baseline Hba1csupporting

confidence: 79%

Benefits of the fixed‐ratio combination of insulin glargine 100 units/mL and lixisenatide (iGlarLixi) in Japanese people with type 2 diabetes: A subgroup and time‐to‐control analysis of the LixiLan JP phase 3 trials

Terauchi

Yabe

Kaneto

et al. 2020

Diabetes Obesity Metabolism

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“…The results of an exploratory analysis of the LixiLan-L study showed that iGlarLixi provided consistent improvements in glycemic control, and mitigated (up to − 0.9 kg) the gain in body weight observed with iGlar (up to + 1.1 kg), regardless of HbA1c subgroup (< 8%, ≥ 8%), duration of T2D (< 10, ≥ 10 years), or body mass index (< 30, ≥ 30 kg/m 2 ) [95]. Similar results have been reported from a post hoc analysis of the LixiLan-O study [107], which are further supported by a recently published analysis demonstrating superior glycemic control with iGlarLixi compared with iGlar or lixisenatide in patients with a baseline HbA1c ≥ 9%, with reductions in HbA1c of − 2.9%, − 2.5%, and − 1.7% for iGlarLixi, iGlar, and lixisenatide, respectively [108]. The results of another post hoc analysis of the LixiLan-L study showed that reductions in HbA1c to week 30 were greater for iGlarLixi than iGlar, irrespective of screening HbA1c subgroup (≤ 8%: − 1.1 vs. − 0.5; < 8% to ≤ 9%: − 1.4 vs. − 1.0; > 9%: − 2.4 vs. − 1.8; all p < 0.0001).…”

Section: Fixed-ratio Combination Of Insulin Glargine 100 Units/ml Andsupporting

confidence: 66%

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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“…Mean body weight decreased in iGlarLixi recipients but increased in insulin glargine recipients (between‐group difference, 1.4 kg; P < 0.0001), and the number of hypoglycaemic events was similar in the two groups 53. In both studies, the improvement in glycaemic control with iGlarLixi vs the individual therapies was consistent regardless of baseline HbA 1c , BMI or diabetes duration 54, 55.…”

Section: Fixed‐ratio Formulationsmentioning

confidence: 80%

Use of glucagon‐like peptide‐1 receptor agonists among individuals on basal insulin requiring treatment intensification

Trautmann¹,

Vora

2018

Diabet. Med.

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As Type 2 diabetes progresses, treatment is intensified with additional therapies in an effort to manage hyperglycaemia effectively and therefore avoid complications. When greater efficacy is required, options for injectable treatments include glucagon‐like peptide‐1 receptor agonists and insulin, which may be added on to oral glucose‐lowering treatments. Among individuals receiving long‐acting basal insulin as their first injectable treatment, ~40−60% are unable to achieve or maintain their target HbA1c goals. For these people, treatment intensification options are relatively limited and include the addition of short‐acting prandial insulin or a glucagon‐like peptide‐1 receptor agonist. Glucagon‐like peptide‐1 receptor agonists vary in their effects, with short‐ and long‐acting agents having a greater impact on postprandial and fasting hyperglycaemia, respectively. Studies comparing treatment intensification options have found both glucagon‐like peptide‐1 receptor agonists and prandial insulin to be effective in reducing HbA1c concentrations; however, recipients of glucagon‐like peptide‐1 receptor agonists lost weight and had a greater frequency of gastrointestinal adverse events, whereas those receiving prandial insulin gained weight and had a greater incidence of hypoglycaemia. In addition to the separate administration of a glucagon‐like peptide‐1 receptor agonist and basal insulin, fixed‐ratio combinations of a glucagon‐like peptide‐1 receptor agonist and basal insulin offer a single administration for both treatments but have less flexibility in dose titration than treatment with their individual components. For individuals who require treatment intensification beyond basal insulin, use of these various options allows physicians to target the individual needs of their patients for the achievement of optimal long‐term glycaemic control.

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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

Cited by 23 publications

References 11 publications

Benefits of the fixed‐ratio combination of insulin glargine 100 units/mL and lixisenatide (iGlarLixi) in Japanese people with type 2 diabetes: A subgroup and time‐to‐control analysis of the LixiLan JP phase 3 trials

Benefits of the fixed‐ratio combination of insulin glargine 100 units/mL and lixisenatide (iGlarLixi) in Japanese people with type 2 diabetes: A subgroup and time‐to‐control analysis of the LixiLan JP phase 3 trials

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

Use of glucagon‐like peptide‐1 receptor agonists among individuals on basal insulin requiring treatment intensification

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