Department of Diabetes, Nutrition and Metabolic Diseases, Iuliu Hațieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
Clinical Center of Diabetes, Nutrition and Metabolic Diseases, County Clinical Emergency Hospital, Cluj-Napoca, Romania.
BMJ Open. 2022 May 27;12(5):e060852. doi: 10.1136/bmjopen-2022-060852.
To assess the effectiveness and safety of insulin glargine and lixisenatide (iGlarLixi) fixed-ratio combination on a cohort of Romanian adults with type 2 diabetes (T2D).
Open-label, 24-week, prospective cohort study.
65 secondary care diabetes centres in Romania.
The study included 901 adults with T2D suboptimally controlled with previous oral antidiabetic drugs (OADs)±basal insulin (BI) who initiated treatment with iGlarLixi upon the decision of the investigator. Major exclusion criteria were iGlarLixi contraindications and refusal to participate. 876 subjects received at least one dose of iGlarLixi (intention-to-treat/safety population).
The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to week 24 in the modified intention-to-treat population (study participants with HbA1c available at baseline and week 24). Secondary efficacy outcomes were percentage of participants reaching HbA1c targets and change in fasting plasma glucose (FPG).
Mean baseline HbA1c was 9.2% (SD 1.4) and FPG was 10.8 mmol/L (2.9). Mean HbA1c change was -1.3% (95% CI: -1.4% to -1.2%, p<0.0001) at week 24. HbA1c levels ≤6.5%, <7% and<7.5% at week 24 were achieved by 72 (8.9%), 183 (22.6%) and 342 (42.3%) participants, respectively. Mean FPG change was -3.1 mmol/L (95% CI: -3.3 to -2.8, p<0.001) at week 24. Mean body weight change was -1.6 kg (95% CI: -1.9 to -1.3, p<0.001) at 24 weeks. Mean iGlarLixi dose increased from 19.5 U (SD 7.7) and 30.1 U (10.0) to 30.2 U (8.9) (ratio 2/1 pen) and 45.0 U (11.6) (ratio 3/1 pen). Adverse events (AEs) were reported by 43 (4.9%) participants (18 (2.1%) gastrointestinal) with 4 (0.5%) reporting serious AEs. 13 (1.5%) participants reported at least one event of symptomatic hypoglycaemia, with one episode of severe hypoglycaemia reported.
In a real-world setting, 24-week treatment with iGlarLixi provided a significant reduction of HbA1c with body weight loss and low hypoglycaemia risk in T2D suboptimally controlled with OADs±BI treatment.
评估甘精胰岛素和利西那肽（iGlarLixi）固定比例组合在罗马尼亚 2 型糖尿病（T2D）成人队列中的疗效和安全性。
开放标签、24 周前瞻性队列研究。
罗马尼亚 65 个二级保健糖尿病中心。
该研究纳入了 901 名以前接受过口服降糖药（OAD）±基础胰岛素（BI）治疗但控制不佳的 T2D 成年人，在研究者决定后开始使用 iGlarLixi 治疗。主要排除标准为 iGlarLixi 禁忌证和拒绝参与。876 名受试者接受了至少一剂 iGlarLixi（意向治疗/安全性人群）。
主要终点是在改良意向治疗人群（基线和 24 周时 HbA1c 可用的研究参与者）中从基线到 24 周时糖化血红蛋白（HbA1c）的变化。次要疗效终点是达到 HbA1c 目标的参与者比例和空腹血浆葡萄糖（FPG）的变化。
平均基线 HbA1c 为 9.2%（SD 1.4），FPG 为 10.8mmol/L（2.9）。24 周时平均 HbA1c 变化为-1.3%（95%CI：-1.4%至-1.2%，p<0.0001）。24 周时达到 HbA1c 水平≤6.5%、<7%和<7.5%的参与者分别为 72 名（8.9%）、183 名（22.6%）和 342 名（42.3%）。24 周时 FPG 平均变化为-3.1mmol/L（95%CI：-3.3 至-2.8，p<0.001）。24 周时平均体重变化为-1.6kg（95%CI：-1.9 至-1.3，p<0.001）。24 周时甘精胰岛素剂量从 19.5U（SD 7.7）和 30.1U（10.0）增加到 30.2U（8.9）（2/1 笔比例）和 45.0U（11.6）（3/1 笔比例）。43 名（4.9%）参与者报告了不良事件（AE）（18 名[2.1%]为胃肠道），其中 4 名（0.5%）报告了严重 AE。13 名（1.5%）参与者报告了至少一次有症状的低血糖事件，报告了 1 例严重低血糖事件。
在真实环境中，24 周的 iGlarLixi 治疗可显著降低糖化血红蛋白水平，同时体重减轻，低血糖风险低，适用于 OAD±BI 治疗控制不佳的 T2D 患者。
