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Evaluation of the efficacy and safety of lixisenatide add-on treatment to basal insulin therapy among T2DM patients with different body mass indices from GetGoal trials.

ABSTRACT: Using patient data from the GetGoal-Duo1, -L, and L-Asia trials, the objectives of this study were to evaluate and compare the impact of lixisenatide once-daily add-on treatment to basal insulin therapy ±oral antidiabetic drugs (OADs) among type 2 diabetes (T2DM) patients subdivided into groups, based on their baseline body mass indices (BMI).Data of patients treated with lixisenatide were extracted from the modified intent-to-treat populations of the trials. Patients were subdivided into 4 groups based on baseline BMI category (BMIs <25, 25-<30, 30-<35, and ?35 kg/m(2)). At the unadjusted data level, efficacy and safety endpoints were evaluated and compared among study cohorts. Additionally, multivariable regression analyses were used to specify key patient characteristics and then assess the adjusted outcomes.Of the 662 T2DM patients, the mean changes in HbA1c (-0.63 to -0.73 %, p = 0.88) and FPG levels (-3.9 to 3.2 mg/dL, p = 0.60) were not significantly different among the different BMI groups. The proportions of T2DM patients that achieved HbA1c <7 % ranged between 34.7 and 46.8 %. After adjusted for patient characteristics, T2DM patients in the lowest BMI group relative to those in the highest BMI group had a smaller reduction in HbA1c during the trial periods (difference: 0.32 %, confidence interval: 0.10, 0.53, p = 0.005) and were less likely to achieve HbA1c <7 %.The findings of this analysis of the GetGoal clinical trials suggest that lixisenatide may be a good treatment option for optimizing glycemic control in patients unable to achieve their HbA1c target on basal insulin therapy ±OADs, regardless of BMI category.

SUBMITTER: Eto K

PROVIDER: S-EPMC4654794 | biostudies-other | 2015

REPOSITORIES: biostudies-other

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Evaluation of the efficacy and safety of lixisenatide add-on treatment to basal insulin therapy among T2DM patients with different body mass indices from GetGoal trials.

Eto Kazuhiro K Naito Yusuke Y Seino Yutaka Y

Diabetology & metabolic syndrome 20151121

<h4>Background</h4>Using patient data from the GetGoal-Duo1, -L, and L-Asia trials, the objectives of this study were to evaluate and compare the impact of lixisenatide once-daily add-on treatment to basal insulin therapy ±oral antidiabetic drugs (OADs) among type 2 diabetes (T2DM) patients subdivided into groups, based on their baseline body mass indices (BMI).<h4>Methods</h4>Data of patients treated with lixisenatide were extracted from the modified intent-to-treat populations of the trials. P ...[more]

PMID: 26594250

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Project description:We assessed the cost-effectiveness of the glucagon-like peptide 1 receptor agonists liraglutide 1.8 mg and lixisenatide 20 ?g (both added to basal insulin) in patients with type 2 diabetes (T2D) in Sweden.The Swedish Institute for Health Economics cohort model for T2D was used to compare liraglutide and lixisenatide (both added to basal insulin), with a societal perspective and with comparative treatment effects derived by indirect treatment comparison (ITC). Drug prices were 2016 values, and all other costs 2015 values. The cost-effectiveness of IDegLira (fixed-ratio combination of insulin degludec and liraglutide) versus lixisenatide plus basal insulin was also assessed, under different sets of assumptions.From the ITC, decreases in HbA1c were -1.32% and -0.43% with liraglutide and lixisenatide, respectively; decreases in BMI were -1.29 and -0.65 kg/m2, respectively. An estimated 2348 cases of retinopathy, 265 of neuropathy and 991 of nephropathy would be avoided with liraglutide compared with lixisenatide in a cohort of 10,000 patients aged over 40 years. In the base-case analysis, total direct costs were higher with liraglutide than lixisenatide, but costs associated with complications were lower. The cost/quality-adjusted life-year (QALY) for liraglutide added to basal insulin was SEK30,802. Base-case findings were robust in sensitivity analyses, except when glycated haemoglobin (HbA1c) differences for liraglutide added to basal insulin were abolished, suggesting these benefits were driving the cost/QALY. With liraglutide 1.2 mg instead of liraglutide 1.8 mg (adjusted for efficacy and cost), liraglutide added to basal insulin was dominant over lixisenatide 20?g.IDegLira was dominant versus lixisenatide plus basal insulin when a defined daily dose was used in the model.The costs/QALY for liraglutide, 1.8 or 1.2 mg, added to basal insulin, and for IDegLira (all compared with lixisenatide 20 ?g added to basal insulin) were below the threshold considered low by Swedish authorities. In some scenarios, liraglutide and IDegLira were cost-saving.

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Dataset Information

Evaluation of the efficacy and safety of lixisenatide add-on treatment to basal insulin therapy among T2DM patients with different body mass indices from GetGoal trials.

Publications

Evaluation of the efficacy and safety of lixisenatide add-on treatment to basal insulin therapy among T2DM patients with different body mass indices from GetGoal trials.

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