Lixisenatide is effective and safe as add-on treatment to basal insulin in Asian individuals with type 2 diabetes and different body mass indices: a pooled analysis of data from the GetGoal Studies

Abstract

IntroductionThis analysis aims to investigate the efficacy and safety of once-daily lixisenatide add-on treatment to basal insulin in Asian individuals with type 2 diabetes, by baseline body mass index (BMI).Research design and methodsData from all Asian participants in the placebo-controlled GetGoal-Duo 1, GetGoal-L, and GetGoal-L-C Studies were pooled and categorized according to the following BMI subgroups:<25 kg/m2, 25–<30 kg/m2 and ≥30 kg/m2. Efficacy and safety of lixisenatide versus placebo were evaluated among BMI subgroups. Multivariable regression analyses were also conducted to explore the potential influence of BMI on efficacy outcomes after adjusting for baseline characteristics.Results555 participants were included (mean age 53.9 years, 52.4% men). No significant differences in treatment effect between the BMI subgroups were observed for the changes from baseline to 24 weeks in glycated hemoglobin (HbA1c), fasting plasma glucose, postprandial glucose (PPG), PPG excursion, body weight, BMI, and basal insulin dose with lixisenatide, as well as the change in basal insulin dose at study endpoint and the proportion of participants achieving an HbA1c <7% at 24 weeks (all p values for interaction >0.15). In the multivariable regression analysis, participants in the lowest BMI group had a smaller reduction in body weight over the 24-week treatment period relative to the highest BMI group (p=0.023).ConclusionsThis post hoc analysis indicates that lixisenatide improved glycemic control regardless of baseline BMI and was well tolerated in Asian individuals unable to achieve their HbA1c target on basal insulin±oral antidiabetic drugs.

Impact of Type 2 Diabetes Duration on the Efficacy and Safety of Add-on Lixisenatide in Asian Individuals Receiving Basal Insulin: A Pooled Analysis

“…Accordingly, the findings of this analysis cannot be generalized to other settings or patient groups, nor indeed can any possible differences between Asian and non-Asian individuals regarding the influence of T2D duration on treatment outcomes be determined. Lastly, the current analysis focused exclusively on T2D duration and a prior report examined the effect of baseline BMI on the effectiveness and safety of lixisenatide in Asian patients [34]; however, the effect on treatment outcomes based on other baseline patient or disease characteristics in Asian individuals may be worth investigating, including gender, age, baseline HbA1c, presence/absence of diabetes-related atherosclerotic cardiovascular disease, and the number of background oral antidiabetic agents.…”

Lixisenatide ameliorated lipopolysaccharide (LPS)‐induced expression of mucin and inflammation in bronchial epithelial cells

“…[ 10 ] However, natural human GLP‐1 is easily degraded by dipeptidyl peptidase Ⅳ, and the half‐life of GLP‐1 in plasma is short, [ 11 ] which seriously limits the clinical application of GLP‐l. Lixisenatide, a selective GLP‐1 receptor agonist, is marketed in the European Union for the treatment of type 2 diabetes mellitus, [ 12 ] is composed of 44 amino acids, and can stably pass through the blood–brain barrier. Compared with several GLP‐1s that have been applied in clinical practice, lixisenatide shows superior biological activity.…”

“…Lixisenatide, a selective GLP-1 receptor agonist, is marketed in the European Union for the treatment of type 2 diabetes mellitus, [12] is composed of 44 amino acids, and can stably pass through the blood-brain barrier. Compared with several GLP-1s that have been applied in clinical practice, lixisenatide shows superior biological activity.…”

Pharmacokinetics and Safety of iGlarLixi in Healthy Chinese Participants: Results of a Phase 1 Randomized Study

“…iGlarLixi combines the complementary fasting plasma glucose (FPG) reduction of basal insulin glargine 100 U/ml (iGlar) and PPG reduction of the GLP-1 RA, lixisenatide (Lixi), in a convenient single daily injection, providing an efficacious treatment option for people advancing therapy from a variety of background therapies [ 3 – 11 ]. iGlarLixi has shown greater glycemic control than either iGlar or lixisenatide alone and has no additional risk of hypoglycemia compared to iGlar in people with T2D from Chinese mainland, Korea, Malaysia, Taiwan and Hong Kong SAR in the Asian Pacific region [ 12 – 14 ].…”