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A real‐world, observational study of weekly exenatide added to basal insulin in patients with type 2 diabetes mellitus (NCT02895672)

机译:对2型糖尿病患者每周在基础胰岛素中添加艾塞那肽的现实观察研究(NCT02895672)

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Summary AimThis is a pre-post observational study from an endocrinology ambulatory care practice which assessed the effectiveness and safety following the addition of a glucagon-like peptide-1 (GLP-1) agonist, weekly exenatide (Bydureon), to basal insulin therapy in patients with type 2 diabetes mellitus (T2DM). Liraglutide plus basal insulin served as a comparison group. Materials and methodsA data collection form was utilized to collect study-related information. The primary study outcome was change in HbA1c from baseline to 12?months after GLP-1 receptor agonist therapy was added to basal insulin therapy. Secondary outcomes were change in weight, percentage of patients achieving an HbA1c of ResultsOne-hundred and fifty patients met inclusion criteria (seventy-five per treatment arm). After 1?year of therapy, HbA1c decreased by 0.7% in the entire cohort (once-weekly exenatide: ?0.7%; once-daily liraglutide: ?0.8%; no significant between-group difference). More subjects in the weekly exenatide arm achieved an HbA1c?1c?≤?6.5% (48?mmol/mol). Although significantly more patients achieved an HbA1c?1c was lower (7.9%) than the liraglutide arm (8.4%). No significant differences were observed between groups for other secondary outcomes. A similar number of subjects discontinued therapy, mainly due to gastrointestinal-ill effects, and hypoglycaemia incidence did not increase compared with the previous year. ConclusionThe addition of once-weekly exenatide to basal insulin was associated with appreciable reductions in HbA1c and weight without an increase in hypoglycaemia.
机译:摘要目的这是一项来自内分泌门诊护理实践的事前观察性研究,该研究评估了胰高血糖素样肽1(GLP-1)激动剂每周艾塞那肽(Bydureon)加入基础胰岛素治疗后的有效性和安全性。 2型糖尿病(T2DM)患者。利拉鲁肽加基础胰岛素作为对照组。材料和方法使用数据收集表收集与研究相关的信息。主要研究结果是在基础胰岛素治疗中加入GLP-1受体激动剂治疗后,HbA 1c 从基线到12个月的变化。次要结果是体重变化,达到结果HbA 1c 的患者百分比一百零五十名患者符合纳入标准(每支治疗臂55名)。治疗1年后,整个队列中的HbA 1c 下降了0.7%(艾塞那肽每周一次:0.7%;利拉鲁肽每天一次:0.8%;组间无显着性差异) 。每周艾塞那肽组的受试者中HbA 1c ?1c ?≤≤6.5%(48?mmol / mol)。尽管实现HbA 1c ?1c 的患者明显多于利拉鲁肽组(8.4%),但这一比例较低(7.9%)。两组之间在其他次要结局方面未见明显差异。数量相近的受试者停止治疗,主要是由于胃肠道疾病的影响,低血糖发生率与上一年相比没有增加。结论每周一次向基础胰岛素中添加艾塞那肽可显着降低HbA 1c 和体重,而不会降低低血糖症。

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