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首页> 外文期刊>Journal of diabetes. >Efficacy and safety of lixisenatide as add‐on therapy to basal insulin in older adults with type 2 diabetes in the GetGoal‐O Study
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Efficacy and safety of lixisenatide as add‐on therapy to basal insulin in older adults with type 2 diabetes in the GetGoal‐O Study

机译：lixisenatide随着添加量的临床疗效和安全性基础胰岛素治疗老年人2型糖尿病在GetGoal O应承担的研究

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Abstract Background This study compared the efficacy and safety of lixisenatide with placebo as add‐on therapy to basal insulin (BI) in adults aged ≥70?years with type 2 diabetes (T2D), with or without moderate renal insufficiency. Methods This post hoc analysis evaluated data from non‐frail patients with T2D inadequately controlled on BI with or without oral antidiabetic drugs (n = 108), randomized to once‐daily lixisenatide 20?μg or placebo for 24?weeks (GetGoal‐O Study). The primary endpoint was the change in HbA1c from baseline to Week 24. Secondary endpoints included changes from baseline in fasting plasma glucose, 2‐hour postprandial plasma glucose (PPG), average seven‐point self‐monitored plasma glucose (SMPG), area under the curve for SMPG, daily BI dose, body weight, proportion of patients achieving HbA1c ??0.5%, and composite endpoints. Safety outcomes included the incidence of documented symptomatic hypoglycemia (plasma glucose 60?mg/dL) and gastrointestinal treatment‐emergent adverse events (TEAEs). Outcomes were also analyzed by the occurrence of moderate renal insufficiency. Results Compared with placebo, lixisenatide‐treated patients had significantly greater reductions in HbA1c, 2‐hour PPG, average seven‐point SMPG, and body weight. Documented symptomatic hypoglycemia was approximately two‐fold higher in patients treated with placebo than lixisenatide (12.7% vs 5.7%). GI TEAEs occurred more frequently in the lixisenatide‐ than placebo‐treated group (34% vs 9.1%). Moderate renal insufficiency (estimated glomerular filtration rate between ≥30 and?60?mL/min/1.73?m 2 ) did not negatively affect lixisenatide efficacy or safety. A greater proportion of patients treated with lixisenatide than placebo achieved composite endpoints. Conclusions Add‐on therapy with lixisenatide in non‐frail patients aged ≥70?years with T2D uncontrolled with BI is effective, safe, and well tolerated and should be considered in this population.
机译：本研究比较了抽象背景lixisenatide与安慰剂的疗效和安全性添加量在治疗成人基础胰岛素(BI)≥70岁吗?或没有中度肾功能不全。这种事后分析评价数据非虚弱的病人与T2D不足控制在BI有或没有口服抗糖尿病的药物(n = 108),随机一旦列车每日lixisenatide 20吗?24 ?从基线糖化血红蛋白的变化到24周。二次端点包括变化的空腹血糖基线,2小时餐后血糖(PPG)的平均水平七个必经点自我检测血糖监测(SMPG),曲线下的面积SMPG,每日BI剂量,体重,实现病人的比例糖化血红蛋白祝辞? 0.5%,复合端点。结果包括记录的发病率症状性低血糖(血糖& 60 mg / dL)和胃肠道治疗量紧急不良事件(流泪)。结果也发生的分析中度肾功能不全。与安慰剂,lixisenatide治疗患者明显更大的降低糖化血红蛋白、2小时分,平均7点SMPG应承担的,体重。记录症状性低血糖症是高患者的大约两倍与安慰剂相比,lixisenatide (12.7% vs 5.7%)。胃肠道流泪更频繁地发生lixisenatide量比安慰剂治疗组(34% vs9.1%)。肾小球滤过率≥30之间然后呢? & 60 ? mL / min / 1.73吗?影响lixisenatide功效和安全性。lixisenatide患者的比例比安慰剂实现复合端点。结论治疗与lixisenatide上添加量非必经虚弱的病人年龄≥70岁?BI是有效控制,安全,容忍,应该考虑这一点人口。

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