Comparisons of efficacy and safety in insulin glargine and lixisenatide plus glulisine combination therapy with multiple daily injection therapy in Japanese patients with type 2 diabetes

Kawaguchi, Yuji; Miyamoto, Shoko; Hajika, Yuriko; Ashida, Narumi; Masumoto, Koji; Sawa, Jun; Hamazaki, Kenji; Kumeda, Yasuro

doi:10.1111/jdi.13677

Cited by 6 publications

(7 citation statements)

References 40 publications

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“…dTBR was low with iGlarLixi, at 0.71% and 0.42% in the two studies. A Japanese study showed that level 1 TBR (< 70 mg/dL) in the iGlarLixi + insulin glulisine group was significantly lower than that in the glargine + glulisine group (1.5% ± 2.5% vs. 2.9% ± 4.7%, P = .047), 35 supporting that iGlarLixi has a low risk of hypoglycaemia.…”

Section: Discussionmentioning

confidence: 94%

iGlarLixi provides a higher derived time‐in‐range versus insulin glargine 100 U/mL or lixisenatide in Asian Pacific people with type 2 diabetes: A post hoc analysis

Yang

Zhang

et al. 2023

Diabetes Obesity Metabolism

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Aim: To evaluate the efficacy of iGlarLixi in the Asian Pacific (AP) population with type 2 diabetes (T2D) using derived time-in-ranges calculated from seven-point selfmeasured blood glucose.Methods: Two phase III trials were analysed. LixiLan-O-AP was performed in insulinnaive T2D patients (n = 878) randomized to iGlarLixi, glargine 100 units/mL (iGlar) or lixisenatide (Lixi). LixiLan-L-CN was performed in insulin-treated T2D patients (n = 426) randomized to iGlarLixi or iGlar. Changes in derived time-in-ranges from baseline to end-oftreatment (EOT) and estimated treatment differences (ETDs) were analysed. The proportions of patients achieving 70% or higher derived time-in-range (dTIR), 5% or higher dTIR improvement, and the composite triple target (≥ 70% dTIR, < 4% derived time-below-therange [dTBR] and < 25% derived time-above-the-range [dTAR]) were calculated. Results:The changes from baseline to EOT in dTIR with iGlarLixi were greater versus iGlar (ETD 1 : 11.45% [95% CI, 7.66% to 15.24%]) or Lixi (ETD 2 : 20.54% [95% CI, 15.74% to 25.33%]) in LixiLan-O-AP, and versus iGlar (ETD: 16.59% [95% CI, 12.09% to 21.08%]) in LixiLan-L-CN. In LixiLan-O-AP, the proportions of patients achieving 70% or higher dTIR or 5% or higher dTIR improvement at EOT with iGlarLixi were 77.5% and 77.8%, respectively, higher than with iGlar (61.1% and 75.3%) or Lixi (47.0% and 53.0%). In LixiLan-L-CN, the proportions of patients achieving 70% or higher dTIR or 5% or higher dTIR improvement at EOT were 71.4% and 59.8% with iGlarLixi, greater than with iGlar (45.4% and 39.5%). More patients achieved the triple target with iGlarLixi compared with iGlar or Lixi. Conclusion: iGlarLixi achieved greater improvements in dTIR parameters versus iGlaror Lixi in insulin-naïve and insulin-experienced AP people with T2D.

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Section: Discussionmentioning

confidence: 94%

iGlarLixi provides a higher derived time‐in‐range versus insulin glargine 100 U/mL or lixisenatide in Asian Pacific people with type 2 diabetes: A post hoc analysis

Yang

Zhang

et al. 2023

Diabetes Obesity Metabolism

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“…Така тактика є ініціативною і не має чітких рекомендацій від діабетологічних товариств, клінічні дослідження із спрощення складних режимів інсулінотерапії не проводилися. Наявні публікації про поодинокі клінічні випадки та аналізи досвіду спрощення інсулінотерапії в рамках однієї клініки [42,43] або навіть цілої країни [40,41]. Загалом результати є настільки успішними, що до тактики зі спрощення інсулінотерапії з переходом на фіксовану комбінацію долучається усе більше лікарів.…”

Section: результати та обговоренняunclassified

“…Вбачається цілком ймовірним, що діабетологічні товариства сформують уніфіковані підходи до деінтенсифікації на базі результатів реальної клінічної практики без проведення великих клінічних досліджень. Невеликі ж дослідження доводять ефективність та безпечність такої тактики [41][42][43].…”

Section: результати та обговоренняunclassified

Issues of insulin therapy for type 2 diabetes and ways to solve them

Katerenchuk

2023

Mìžnarodnij endokrinologìčnij žurnal

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The article is a summary of personal experience and literature data from PubMed, Scopus, Web of Science, ClinicalTrials.gov databases. As a result of the analysis, the main problems faced by practical endocrinologists when administering insulin therapy to patients with type 2 diabetes mellitus (T2DM) have been determined. Insulin therapy remains an important component of glucose-lowering therapy in T2DM. A significant increase in the number of oral hypoglycemic agents has allowed delaying the start of insulin therapy but the treatment for T2DM without insulin is not real today. The current problems of insulin therapy are as follows: untimely start, insufficient titration of the dose of basal insulin, excessive use of basal and bolus insulins, the irrationality of the use of premixes and the basis bolus regimen of insulin therapy. There are methods to overcome each of these issues that have proven their effectiveness according to clinical trials and real clinical practice data. The combination of insulin and oral therapy plays an important role, the addition of oral hypoglycemic agents is effective at different stages of insulin therapy. One of the most promising options is the use of fixed combinations of basal insulin with glucagon-like peptide-1 receptor agonists. Fixed combinations can be used as initial therapy and are often the first step when changing other insulin therapy regimens. The use of fixed combinations can be an option for modification (simplification) of complex insulin therapy regimens, including the basal bolus regimen. Authors review current evidence and circumstances in which insulin can be used, consider individualized choices of alternatives and combination regimens, and offer some guidance on personalized targets and approaches to glycemic control in type 2 diabetes. In general, most of the modern problems of insulin therapy have options for successful overcome.

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“…However, the time below range (TBR) level 1 16 percent of readings and the time at 54–69 mg/dL were significantly lower with IGlarLixi and IGlu therapies than with MDI and IGlarLixi and IGlu therapies. A significant negative correlation was identified between C‐peptide immunoreactivity (CPR) values and IGlu dosage 17 . Furthermore, the authors compared IDegLira and insulin degludec/insulin aspart (IDegAsp) injected pre‐supper and reported that IDegLira had a significantly higher TIR than IDegAsp, suppressed postprandial glucose levels at breakfast and lunch, and had a significant negative correlation with a 24 h coefficient of variation (CV) of glycemic variability (GV) and C‐peptide index (CPI) 18 .…”

Section: Introductionmentioning

confidence: 99%

Comparison of efficacy and safety of insulin degludec/liraglutide and insulin glargine U‐100/lixisenatide in individuals with type 2 diabetes mellitus using professional continuous glucose monitoring

Kawaguchi,

Hajika,

Rinka

et al. 2024

J of Diabetes Invest

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Aim/IntroductionInsulin glargine U100/lixisenatide and insulin degludec/liraglutide are fixed‐ratio combinations containing basal insulin and a glucagon‐like peptide‐1 receptor agonist capable of reducing both fasting and postprandial blood glucose levels with a single formulation. This study aimed to compare the time in range (TIR) and the time below range (TBR) level 1 using professional continuous glucose monitoring and to establish criteria for the differential use of the fixed‐ratio combinations.Materials and MethodsThirty‐six outpatients with type 2 diabetes mellitus (24 men and 12 women; average age, 62.1 years) were randomly assigned to the groups. At 0 and 18 weeks, a device was worn to compare the TIR and TBR level 1. The correlation between the C‐peptide index at baseline and TIR at 18 weeks was assessed.ResultsThe TIR and TBR level 1 showed no significant differences between the two groups. Both groups showed significant positive correlations between the C‐peptide index and the TIR (P = 0.002, r = 0.679; P = 0.002, r = 0.681, respectively). The changes in glycemic variability, therapeutic indices, and body mass index were not significantly different among the groups (P > 0.05). The receiver operating curve analysis revealed that the cut‐off values of the C‐peptide index to achieve TIR of >70% at 18 weeks were 1.258 (sensitivity, 77.8%; specificity, 100%) and 1.099 (sensitivity, 57.1%; specificity, 90.9%) in the insulin glargine U100/lixisenatide and insulin degludec/liraglutide groups, respectively.ConclusionsA TIR of >70% was achieved for both fixed‐ratio combinations without significant differences.

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Comparisons of efficacy and safety in insulin glargine and lixisenatide plus glulisine combination therapy with multiple daily injection therapy in Japanese patients with type 2 diabetes

Cited by 6 publications

References 40 publications

iGlarLixi provides a higher derived time‐in‐range versus insulin glargine 100 U/mL or lixisenatide in Asian Pacific people with type 2 diabetes: A post hoc analysis

iGlarLixi provides a higher derived time‐in‐range versus insulin glargine 100 U/mL or lixisenatide in Asian Pacific people with type 2 diabetes: A post hoc analysis

Issues of insulin therapy for type 2 diabetes and ways to solve them

Comparison of efficacy and safety of insulin degludec/liraglutide and insulin glargine U‐100/lixisenatide in individuals with type 2 diabetes mellitus using professional continuous glucose monitoring

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