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在患有 1 型或 2 型糖尿病的人群中,无论之前使用何种基础胰岛素治疗,转换使用德谷胰岛素均可带来临床获益:来自一项欧洲、多中心、回顾性、非干预性研究(EU-TREAT)的证据。

Clinical benefits of switching to insulin degludec irrespective of previous basal insulin therapy in people with Type 1 or Type 2 diabetes: evidence from a European, multicentre, retrospective, non-interventional study (EU-TREAT).

机构信息

Steno Diabetes Centre Aarhus, Aarhus University Hospital, Aarhus, Denmark.

Department of Medicine, Padova University, Padova, Italy.

出版信息

Diabet Med. 2019 Jul;36(7):868-877. doi: 10.1111/dme.13976. Epub 2019 May 2.

Abstract

AIMS

To investigate whether the benefits of switching to insulin degludec observed in the European retrospective chart review study EU-TREAT were dependent on the previous basal insulin used.

METHODS

People with Type 1 or Type 2 diabetes were switched to insulin degludec from other basal insulins ≥6 months before data collection. Participants were stratified into three groups based on their previous basal insulin: insulin glargine 100 units/ml (Type 1: n=888; Type 2: n=259); insulin detemir (Type 1: n=726; Type 2: n=415); and neutral protamine Hagedorn (Type 1: n=53; Type 2: n=95). Their glycaemic control and hypoglycaemia incidence at 6 and 12 months post-switch vs pre-switch was then evaluated.

RESULTS

Significant HbA reductions were achieved in all previous basal insulin groups for participants with Type 1 diabetes [insulin glargine 100 units/ml: -2.08 mmol/mol (-0.19%); insulin detemir: -2.40 mmol/mol (-0.22%)] and those with Type 2 diabetes [insulin glargine 100 units/ml: -5.90 mmol/mol (-0.54%); insulin detemir: -6.01 mmol/mol (-0.55%); neutral protamine Hagedorn: -2.73 mmol/mol (-0.25%)] at 6 months, except for the relatively small neutral protamine Hagedorn group in those with Type 1 diabetes [-1.75 mmol/mol (-0.16%)], where statistical significance was not reached. At 6 months in the Type 1 diabetes group, switching to insulin degludec from insulin glargine 100 units/ml resulted in significantly lower hypoglycaemia rates across all hypoglycaemia categories; for the insulin detemir group, this significance was also observed for severe and nocturnal non-severe hypoglycaemia, while the low number of people in the neutral protamine Hagedorn group resulted in nonsignificant reductions in hypoglycaemia rates. At 6 months in the people with Type 2 diabetes, switching to insulin degludec resulted in significantly lower rates of hypoglycaemia across all categories for all groups. Similar outcomes were observed at 12 months.

CONCLUSIONS

Switching to insulin degludec from other basal insulins can improve glycaemic control and/or reduce hypoglycaemia risk in people with diabetes (although there was a nonsignificant reduction in HbA and hypoglycaemia rates for the neutral protamine Hagedorn group in Type 1 diabetes) under routine care.

摘要

目的

探讨欧洲回顾性图表研究 EU-TREAT 中观察到的改用德谷胰岛素的获益是否依赖于先前使用的基础胰岛素。

方法

1 型或 2 型糖尿病患者在数据收集前至少 6 个月从其他基础胰岛素转为德谷胰岛素。根据先前的基础胰岛素将参与者分为三组:甘精胰岛素 100 单位/毫升(1 型:n=888;2 型:n=259);地特胰岛素(1 型:n=726;2 型:n=415);和中性鱼精蛋白锌胰岛素(1 型:n=53;2 型:n=95)。然后评估他们在转换后 6 个月和 12 个月与转换前相比的血糖控制和低血糖发生率。

结果

1 型糖尿病患者中所有先前基础胰岛素组的 HbA 均显著降低[甘精胰岛素 100 单位/毫升:-2.08mmol/mol(-0.19%);地特胰岛素:-2.40mmol/mol(-0.22%)],2 型糖尿病患者[甘精胰岛素 100 单位/毫升:-5.90mmol/mol(-0.54%);地特胰岛素:-6.01mmol/mol(-0.55%);中性鱼精蛋白锌胰岛素:-2.73mmol/mol(-0.25%)],除了 1 型糖尿病中相对较小的中性鱼精蛋白锌胰岛素组[-1.75mmol/mol(-0.16%)],未达到统计学意义。在 1 型糖尿病组中,从甘精胰岛素 100 单位/毫升转换为德谷胰岛素在所有低血糖类别中均显著降低低血糖发生率;对于地特胰岛素组,严重和夜间非严重低血糖也观察到这种意义,而中性鱼精蛋白锌胰岛素组的人数较少导致低血糖发生率无显著降低。在 2 型糖尿病患者中,从其他基础胰岛素转换为德谷胰岛素在所有组别和所有类别中均显著降低低血糖发生率。在 12 个月时也观察到类似的结果。

结论

在常规护理下,从其他基础胰岛素转换为德谷胰岛素可改善糖尿病患者的血糖控制和/或降低低血糖风险(尽管 1 型糖尿病中性鱼精蛋白锌胰岛素组的 HbA 和低血糖发生率有轻微降低)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6436/6618263/993a3e60e45a/DME-36-868-g001.jpg

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