Use of iGlarLixi for Management of Type 2 Diabetes in Japanese Clinical Practice: SPARTA Japan, a Retrospective Observational Study

Matsuhisa, Munehide; Miyoshi, Hideaki; Yabe, Daisuke; Takahashi, Yoko; Morimoto, Yukiko; Terauchi, Yasuo

doi:10.1007/s13300-022-01333-w

Cited by 3 publications

(14 citation statements)

References 18 publications

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“…S2), but the dose at the end of the treatment period was significantly higher in the group that had received C 10 U/day at baseline versus the group that had received \ 10 U/day (p \ 0.0001). Amongst participants who were receiving BI at baseline, the mean BI dose was 11.9 U/day in the FAS (as previously discussed in the primary SPARTA analysis [13]) and ranged from 8.9 to 12.2 U/day across applicable subgroups (Supplementary Fig. S3a).…”

Section: Dose Changesmentioning

confidence: 87%

“…The rationale for sample size calculations for the primary analysis has been defined previously [13]. In the current report, all analyses are descriptive.…”

Section: Discussionmentioning

confidence: 99%

“…Randomised clinical trials have demonstrated the efficacy and safety of iGlar-Lixi (1:1) in Japanese individuals with T2D that was suboptimally controlled with OADs [9,12] or OADs plus BI [8]. Furthermore, the retrospective, observational 'SPARTA Japan' study confirmed the effectiveness and safety of iGlar-Lixi in routine clinical practice in Japan [13]. In SPARTA Japan, 6 months of iGlarLixi treatment significantly reduced mean glycated haemoglobin (HbA1c) and body weight compared with baseline, with a low incidence of hypoglycaemia and gastrointestinal events.…”

Section: Introductionmentioning

confidence: 94%

“…The study design and methods have been previously described [13]. Briefly, SPARTA Japan was a retrospective, observational study that collected data from the medical records of eligible participants from 27 medical institutions across Japan.…”

Section: Study Design and Populationmentioning

confidence: 99%

“…Of the 469 participants enrolled, 432 were included in the FAS [13]. Of these, 338 met the pre-specified criteria for inclusion in this subgroup analysis; however, one individual in the post BOT subgroup was incorrectly classified as receiving BI, so the total number of participants in this subgroup analysis was 337 (Fig.…”

Section: Study Cohort and Demographicsmentioning

confidence: 99%

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Use of iGlarLixi for the Management of Type 2 Diabetes in Japanese Clinical Practice: Prior Treatment Subgroup Analysis of the SPARTA Japan Study

et al. 2023

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Introduction: iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/mL and the glucagon-like peptide 1 receptor agonist (GLP-1 RA) lixisenatide, is one option for treatment intensification in individuals with type 2 diabetes (T2D) who are unable to achieve targeted glycaemic control with their current glucoselowering agent. Real-world data on the impact of prior treatment on the effectiveness and safety of iGlarLixi may be useful to guide individualised treatment decisions. Methods: This analysis of the 6-month, retrospective, observational SPARTA Japan study compared glycated haemoglobin (HbA1c), body weight and safety for pre-specified subgroups defined by prior treatment: post oral antidiabetic agent (OAD), GLP-1 RA, basal insulin (BI) ? OADs (BOT), GLP-1 RA ? BI or multiple daily injections (MDI). The post BOT and MDI subgroups were further divided on the basis of prior dipeptidyl peptidase 4 inhibitor (DPP-4i) use, and the post MDI group was divided on the basis of whether participants continued bolus insulin. Results: Of the 432 participants in the full analysis set (FAS), 337 were included in this

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Section: Dose Changesmentioning

confidence: 87%

“…The rationale for sample size calculations for the primary analysis has been defined previously [13]. In the current report, all analyses are descriptive.…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 94%

Section: Study Design and Populationmentioning

confidence: 99%

Section: Study Cohort and Demographicsmentioning

confidence: 99%

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Use of iGlarLixi for the Management of Type 2 Diabetes in Japanese Clinical Practice: Prior Treatment Subgroup Analysis of the SPARTA Japan Study

et al. 2023

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Impact of Participant Characteristics on Clinical Outcomes with iGlarLixi in Type 2 Diabetes: Post Hoc Analysis of SPARTA Japan

Yabe,

Matsuhisa,

Takahashi

et al. 2024

Diabetes Ther

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Introduction The real-world SPARTA Japan study confirmed the effectiveness and safety of the fixed-ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) once daily over 6 months in Japanese people with type 2 diabetes (T2D). This post hoc analysis examined the impact of participant characteristics on the achievement of age-defined glycaemic targets with iGlarLixi therapy. Methods The retrospective, observational SPARTA Japan study included adults with T2D who initiated iGlarLixi. In this analysis, data from insulin-naïve and insulin-experienced participants were separately assessed to compare glycated haemoglobin (HbA1c), body weight and safety outcomes between those who achieved (‘achieved’ group) and those who did not achieve (‘not-achieved’ group) age-defined glycaemic targets after 6 months of iGlarLixi. The not-achieved group was further stratified by whether or not their iGlarLixi dose was increased during treatment. Results In total, 418 participants were included in this analysis (138 insulin naïve and 280 insulin experienced). Among both insulin-naïve and insulin-experienced participants, those in the achieved group were older and had lower baseline HbA1c than those in the not-achieved group. Compared with the not-achieved group, the achieved group showed significantly greater HbA1c reductions from baseline (in both insulin-naïve and insulin-experienced participants) and significantly greater body weight reductions (in insulin-naïve participants), despite some participants in the not-achieved group receiving significantly higher insulin glargine doses than those in the achieved group. In both insulin-naïve and insulin-experienced participants, the incidence of hypoglycaemia and gastrointestinal-related adverse events was similar in the achieved and not-achieved groups. In a multivariate analysis, glycaemic target achievement was significantly more likely in older individuals and those who lost weight during iGlarLixi treatment. Conclusions Achievement of age-defined glycaemic targets with iGlarLixi treatment for 6 months was significantly affected by increased age and body weight loss, regardless of prior insulin exposure. Trial Registration UMIN-CTR Trials Registry, UMIN000044126; registered 10 May 2021. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-024-01531-8.

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Real‐world effectiveness and safety of insulin glargine 100 U/mL plus lixisenatide in adults with type 2 diabetes: An international, multicentre, 12‐month, prospective observational study

Malik,

Hwu,

Jammah

et al. 2024

Diabetes Obesity Metabolism

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AimTo assess the impact of insulin glargine (100 U/mL) and lixisenatide (iGlarLixi) fixed‐ratio combination therapy on the overall management of glycaemia in patients with type 2 diabetes (T2D), previously inadequately controlled with oral antidiabetic drugs ± basal insulin or glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs).Materials and MethodsThis 12‐month, international, multicentre, prospective, observational study included patients (age ≥ 18 years) with T2D who had initiated iGlarLixi within 1 month prior to study inclusion. Data were collected at study inclusion, month 3, month 6 and month 12 from patient diaries, self‐measured plasma glucose, and questionnaires. The primary endpoint was change in HbA1c from baseline to month 6.ResultsOf the 737 eligible participants (mean age: 57.8 [standard deviation: 11.2] years; male: 49%), 685 had baseline and post‐baseline HbA1c data available. The least squares mean change in HbA1c from baseline to month 6 was −1.4% (standard error [95% confidence interval (CI)]: 0.05 [−1.5, −1.3]). The absolute change from baseline at month 12 was −1.7% ± 1.9% (95% CI: −1.9, −1.5). There were 72 hypoglycaemia events reported during the study period, with a very low incidence of severe hypoglycaemia (two participants [rate: 0.003 events per patient‐year]).ConclusionsThis real‐world observational study shows that initiation of iGlarLixi in people with T2D inadequately controlled on oral antidiabetic drugs ± basal insulin or GLP‐1 RAs improves glycaemic control with a low incidence of hypoglycaemia.

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Use of iGlarLixi for Management of Type 2 Diabetes in Japanese Clinical Practice: SPARTA Japan, a Retrospective Observational Study

Cited by 3 publications

References 18 publications

Use of iGlarLixi for the Management of Type 2 Diabetes in Japanese Clinical Practice: Prior Treatment Subgroup Analysis of the SPARTA Japan Study

Use of iGlarLixi for the Management of Type 2 Diabetes in Japanese Clinical Practice: Prior Treatment Subgroup Analysis of the SPARTA Japan Study

Impact of Participant Characteristics on Clinical Outcomes with iGlarLixi in Type 2 Diabetes: Post Hoc Analysis of SPARTA Japan

Real‐world effectiveness and safety of insulin glargine 100 U/mL plus lixisenatide in adults with type 2 diabetes: An international, multicentre, 12‐month, prospective observational study

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