一项在英国进行的多中心、回顾性、观察性研究，旨在评估常规临床实践中使用 300 单位/毫升甘精胰岛素治疗 1 型糖尿病患者的疗效（SPARTA）。

A multicentre, UK, retrospective, observational study to assess the effectiveness of insulin glargine 300 units/ml in treating people with Type 1 diabetes mellitus in routine clinical practice (SPARTA).

机构信息

Dudley Group NHS Foundation Trust, Russells Hall Hospital, Dudley.

Institute of Life Science, Swansea University Medical School, Swansea.

出版信息

Diabet Med. 2019 Jan;36(1):110-119. doi: 10.1111/dme.13847. Epub 2018 Nov 16.

AIM

To conduct an open-label study to provide UK real-world evidence regarding the use of insulin glargine 300 units/ml (U300) in people with Type 1 diabetes mellitus.

METHODS

People with Type 1 diabetes who had been prescribed U300 ≥6 months before data collection and had HbA levels recorded within 3 months prior to U300 (baseline) were included. The primary endpoint was change in HbA from baseline to month 6 after U300 initiation. Other endpoints included number of documented hypoglycaemic and diabetic ketoacidosis episodes, and change in daily basal insulin dose.

RESULTS

A total of 298 people with Type 1 diabetes were included [mean age 42.1 years, mean HbA 79 mmol/mol (9.4%)]. After U300 initiation, the mean reduction in HbA from baseline to month 6 was -4 mmol/mol (-0.4%; P<0.001; n=188). The total daily basal insulin dose at 6 months was 1.3 units higher than at the time of U300 initiation (P<0.001; n=275) but was not significantly different from the prior basal insulin dose. There was no clinically significant difference in weight between baseline and month 6 [mean difference +0.7 kg, 95% CI -0.1, 1.5; P=0.084; n=115). During the 6 months before and after U300 initiation, severe hypoglycaemic episodes were documented for 6/298 and 4/298 participants. Diabetic ketoacidosis episodes requiring Accident and Emergency department visits or hospitalization were documented for 4/298 and 6/298 participants, before and after U300 initiation, respectively.

CONCLUSIONS

In people with Type 1 diabetes, a change in basal insulin to U300 was associated with clinically and statistically significant HbA improvements, without significant changes in basal insulin dose and weight. Documented severe hypoglycaemia episodes and diabetic ketoacidosis requiring Accident and Emergency department visits or hospitalization were low and similar before and after U300 initiation.

目的

开展一项开放性研究，提供英国关于 1 型糖尿病患者使用甘精胰岛素 300 单位/毫升（U300）的真实世界证据。

方法

纳入在数据收集前至少 6 个月开始使用 U300 且在 U300 起始前 3 个月内有 HbA 记录的 1 型糖尿病患者。主要终点为 U300 起始后 6 个月时的 HbA 变化。其他终点包括记录的低血糖和糖尿病酮症酸中毒发作次数，以及每日基础胰岛素剂量的变化。

结果

共纳入 298 例 1 型糖尿病患者[平均年龄 42.1 岁，平均 HbA 79 mmol/mol（9.4%）]。U300 起始后，HbA 从基线到第 6 个月的平均下降值为-4 mmol/mol（-0.4%；P<0.001；n=188）。6 个月时的总日基础胰岛素剂量比 U300 起始时高 1.3 单位（P<0.001；n=275），但与之前的基础胰岛素剂量无显著差异。基线和第 6 个月之间的体重无明显差异[平均差异+0.7kg，95%CI-0.1，1.5；P=0.084；n=115）。U300 起始前和后 6 个月内，分别有 6/298 和 4/298 名患者记录了严重低血糖发作。需要急诊就诊或住院的糖尿病酮症酸中毒发作分别有 4/298 和 6/298 名患者记录，发生在 U300 起始前和后。