基础胰岛素治疗控制不佳的患者换用甘精胰岛素300 U/mL的疗效与安全性：TRANSITION 2研究
Efficacy and Safety of Switching Patients Inadequately Controlled on Basal Insulin to Insulin Glargine 300 U/mL: The TRANSITION 2 Study.
作者信息
Gourdy Pierre, Bahloul Amar, Boultif Zahra, Gouet Didier, Guerci Bruno
机构信息
Service de diabétologie, maladies métaboliques et nutrition, CHU et Université de Toulouse, Toulouse, France.
Sanofi, Gentilly, France.
出版信息
Diabetes Ther. 2020 Jan;11(1):147-159. doi: 10.1007/s13300-019-00734-8. Epub 2019 Nov 28.
INTRODUCTION
This study aimed to determine, in close to real-life conditions, the efficacy and safety of switching from any basal insulin to insulin glargine 300 U/mL (Gla-300) in patients with uncontrolled type 2 diabetes (T2D).
METHODS
This was an interventional, multicenter, single-arm, prospective study with a 24-week treatment phase. Adult patients with T2D treated with basal insulin with or without other antidiabetics, HbA1c > 7.5%, and fasting self-monitored blood glucose (F-SMBG) > 130 mg/dL (mean of three measures) at baseline were included. Insulin dose was titrated to reach F-SMBG 90-130 mg/dL. Efficacy and safety were assessed at 12 weeks (W12) and 24 weeks (W24). The main outcome parameter was HbA1c change between baseline and W24. Safety parameters included self-reported hypoglycemia (any type). Patients' satisfaction with the treatment was assessed by the Diabetes Treatment Satisfaction Questionnaire (DTSQ).
RESULTS
A total of 140 patients were included and 137 were treated. Mean HbA1c decreased from 8.64% at baseline to 8.14% at W12 (mean difference [95% CI] - 0.51% [- 0.64; - 0.38]) and 8.01% at W24 (- 0.64% [- 0.81; - 0.46]). Target F-SMBG was reached in 35.0% of the patients at W12 and 38.4% at W24. The percentages of patients reaching HbA1c levels < 7.0%, < 7.5%, and < 8.0% at W24 were 11.4%, 29.5%, and 50.8%, respectively, while only 31.6% had an HbA1c value < 8.0% at baseline. HbA1c reduction was greater in patients with higher baseline levels. During the treatment phase, 46.0% of the participants had at least one hypoglycemia event; 31.4% documented symptomatic hypoglycemia, 2.2% severe hypoglycemia, and 12.2% nocturnal hypoglycemia. Treatment satisfaction increased by 20% between baseline and W24.
CONCLUSION
These data, derived from close to real-life practice in France, confirm the reassuring results of randomized trials on the efficacy and safety of Gla-300.
TRIAL REGISTRATION
EudraCT number 2015-002416-33.
引言
本研究旨在评估在接近实际生活的条件下，将2型糖尿病（T2D）控制不佳患者从任何基础胰岛素转换为甘精胰岛素300 U/mL（Gla-300）的疗效和安全性。
方法
这是一项干预性、多中心、单臂、前瞻性研究，治疗阶段为24周。纳入了接受基础胰岛素治疗（无论是否联用其他降糖药物）、糖化血红蛋白（HbA1c）>7.5%且基线时自我监测空腹血糖（F-SMBG）>130 mg/dL（三次测量的平均值）的成年T2D患者。胰岛素剂量进行滴定以达到F-SMBG 90-130 mg/dL。在12周（W12）和24周（W24）时评估疗效和安全性。主要结局参数为基线至W24时HbA1c的变化。安全参数包括自我报告的低血糖（任何类型）。通过糖尿病治疗满意度问卷（DTSQ）评估患者对治疗的满意度。
结果
共纳入140例患者，137例接受治疗。平均HbA1c从基线时的8.64%降至W12时的8.14%（平均差值[95%置信区间]-0.51%[-0.64；-0.38]），W24时为8.01%（-0.64%[-0.81；-0.46]）。W12时35.0%的患者、W24时38.4%的患者达到目标F-SMBG。W24时HbA1c水平<7.0%、<7.5%和<8.0%的患者比例分别为11.4%、29.5%和50.8%，而基线时只有31.6%的患者HbA1c值<8.0%。基线水平较高的患者HbA1c降低幅度更大。在治疗阶段，46.0%的参与者至少发生一次低血糖事件；31.4%记录有症状性低血糖，2.
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