Effectiveness and Safety of iGlarLixi in People with Type 2 Diabetes in Adriatic Region Countries: ENSURE-ADR, a Real-World Study,Diabetes Therapy

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Effectiveness and Safety of iGlarLixi in People with Type 2 Diabetes in Adriatic Region Countries: ENSURE-ADR, a Real-World Study
Diabetes Therapy ( IF 2.8 ) Pub Date : 2023-05-21 , DOI: 10.1007/s13300-023-01407-3
Danijel Đekić ₁ , Mirjana Bojić ₁ , Andrej Janež ₂ , Sanja Klobučar ₃ , Iris Grčić Hadžimušović ₄ , Tijana Ković ₅ , Svetla Mihalevska ₆

Affiliation

Introduction

The efficacy of iGlarLixi, a fixed-ratio combination of basal insulin glargine 100 units/mL (iGlar) and the short-acting GLP-1 RA lixisenatide (Lixi), was established in people with type 2 diabetes (T2D) who were advancing therapy from oral antidiabetic drugs (OADs) and basal insulin (BI). This retrospective study aimed to evaluate the effectiveness and safety of iGlarLixi using real-world data from people with T2D in the Adriatic region countries.

Methods

This was a non-interventional, retrospective, multicenter, cohort study with the collection of pre-existing data at iGlarLixi initiation and after 6 months of treatment in real-world clinical and ambulatory settings. The primary outcome was the change in glycated hemoglobin (HbA_1c) at 6 months after iGlarLixi initiation. Key secondary outcomes included the proportion of people achieving HbA_1c < 7.0%, the effect of iGlarLixi on fasting plasma glucose (FPG), body weight and body mass index (BMI).

Results

In this study, 262 participants (130 in Bosnia and Herzegovina, 72 in Croatia and 60 in Slovenia) initiated treatment with iGlarLixi. The participants had a mean ± SD age of 66.2 ± 7.9 years and the majority were women (58.0%). The mean baseline HbA_1c was 8.9 ± 1.7% and the mean body weight was 94.3 ± 18.0 kg. After 6 months of treatment, the reduction in the mean HbA_1c was statistically significant (1.11 ± 1.61%, 95% confidence internal [CI] 0.92, 1.31; p < 0.001), and the proportion of participants who achieved HbA_1c < 7.0% had significantly increased from baseline (8.0–26.0%, p < 0.001). The change in mean FPG (mmol/L) levels was significant (2.7 ± 4.4 [95% CI 2.1, 3.2; p < 0.001]). The mean ± SD body weight and BMI were significantly reduced by 2.9 ± 4.3 kg (95% CI 2.3, 3.4; p < 0.001) and 1.3 ± 4.4 kg/m² (95% CI 0.7, 1.8; p < 0.001), respectively. Two serious hypoglycemia episodes and one adverse gastrointestinal effect (nausea) were registered.

Conclusions

This real-world study demonstrated the effectiveness of iGlarLixi for improving glycemic control and decreasing body weight in people with T2D who need to advance therapy from OADs or insulin.

中文翻译：

iGlarLixi 在亚得里亚海地区国家 2 型糖尿病患者中的有效性和安全性：ENSURE-ADR，一项真实世界研究

介绍

iGlarLixi 是基础甘精胰岛素 100 单位/mL (iGlar) 和短效 GLP-1 RA 利西拉来 (Lixi) 的固定比例组合，其疗效在正在推进治疗的 2 型糖尿病 (T2D) 患者中得到证实来自口服抗糖尿病药物 (OAD) 和基础胰岛素 (BI)。这项回顾性研究旨在使用亚得里亚海地区国家 T2D 患者的真实数据评估 iGlarLixi 的有效性和安全性。

方法

这是一项非干预性、回顾性、多中心、队列研究，收集了 iGlarLixi 开始时以及在真实世界临床和门诊环境中治疗 6 个月后的预先存在的数据。主要结果是开始使用 iGlarLixi 后 6 个月糖化血红蛋白 (HbA _1c )的变化。_{关键的次要结果包括达到 HbA 1c} < 7.0%的人的比例，iGlarLixi 对空腹血糖（ FPG ）、体重和体重指数（ BMI ）的影响。

结果

在这项研究中，262 名参与者（130 名在波斯尼亚和黑塞哥维那，72 名在克罗地亚和 60 名在斯洛文尼亚）开始使用 iGlarLixi 进行治疗。参与者的平均 ± SD 年龄为 66.2 ± 7.9 岁，大多数是女性 (58.0%)。平均基线 HbA _1c为 8.9 ± 1.7%，平均体重为 94.3 ± 18.0 kg。_{治疗 6 个月后，平均 HbA 1c}的降低具有统计学意义（1.11 ± 1.61%，95% 置信度内部 [CI] 0.92，1.31；p < 0.001），达到 HbA _1c < 7.0% 的参与者比例与基线相比显着增加 (8.0–26.0%, p < 0.001)。平均 FPG (mmol/L) 水平的变化显着 (2.7 ± 4.4 [95% CI 2.1, 3.2; p < 0.001]）。平均 ± SD 体重和 BMI 分别显着降低 2.9 ± 4.3 kg (95% CI 2.3, 3.4; p < 0.001) 和 1.3 ± 4.4 kg/m ² (95% CI 0.7, 1.8; p < 0.001) . 记录了两次严重的低血糖事件和一次胃肠道不良反应（恶心）。