Liebl A, Wilhelm B, Kaiser M
M&i-Fachklinik Bad Heilbrunn.
MMW Fortschr Med. 2012 Dec 17;154 Suppl 4:102-9.
Hypoglycemic risk and improved glycemic control have to be weightened when a decision on intensification of treatment of type 2 diabetes mellitus with basal insulin is made. Findings from randomized studies are available in this respect, and should be complemented by data from routine treatment.
The international, prospective, open-label, observational study SOLVE (Study of Once-Daily Levemir) investigated add-on treatment with basal insulin in type 2 diabetes mellitus using once daily insulin detemir in patients currently receiving oral antidiabetic drugs (OAD). Data were collected between initiation of insulin treatment and the final visit after approximately 24 weeks. The primary objective of the study was to evaluate the incidence of serious adverse drug reactions (SADR), including major hypoglycemic events.
In Germany, 2,090 patients were eligible for the full analysis set and 1,671 patients for the effectiveness analysis set. The mean age was 64.9 years, mean duration of diabetes 9.36 years, and mean duration of OAD treatment 7.29 years. Three patients (0.14%) experienced a SADR (1 fall resulting in death, 2 major hypoglycemic events). At the final visit, there was a significant reduction in major hypoglycemic events if compared with the period before starting insulin treatment (0.002 versus 0.120 events per patient year, p < 0.001), as were minor hypoglycemic events (0.880 versus 1.588 events per patient year, p = 0.006). The mean body weight and BMI decreased by -0.9 kg (p < 0.001) and-0.35 kg/m2 (p < 0.001) respectively and the mean HbA(1c) level improved from 8.45 +/- 1.19% to 7.30 +/- 0.92% (-1.15 +/- 1.08%; p < 0.001). The mean fasting plasma glucose level and plasma glucose variability were significantly reduced.
Baseline data of the study underline the need for earlier intensification of antidiabetic therapy in type 2 diabetes in Germany. Study results show that within the German diabetes care system, initiation of basal insulin therapy with insulin detemir is able to result in significant HbA(1c) improvements without increased risk of hypoglycemia and/or weight gain.
在决定是否强化基础胰岛素治疗2型糖尿病时，必须权衡低血糖风险和改善血糖控制的情况。这方面已有随机研究的结果，还应以常规治疗的数据作为补充。
国际前瞻性开放标签观察性研究SOLVE（每日一次来得时研究），对目前正在接受口服抗糖尿病药物（OAD）治疗的2型糖尿病患者加用基础胰岛素（每日一次地特胰岛素）进行了研究。在胰岛素治疗开始至约24周后的末次随访期间收集数据。该研究的主要目的是评估严重药物不良反应（SADR）的发生率，包括严重低血糖事件。
在德国，2090例患者符合全分析集标准，1671例患者符合有效性分析集标准。平均年龄为64.9岁，糖尿病平均病程9.36年，OAD治疗平均病程7.29年。3例患者（0.14%）发生了SADR（1例跌倒导致死亡，2例严重低血糖事件）。在末次随访时，与开始胰岛素治疗前相比，严重低血糖事件显著减少（每位患者每年0.002次对0.120次，p<0.001），轻度低血糖事件也减少（每位患者每年0.880次对1.588次，p=0.006）。平均体重和BMI分别下降了-0.9kg（p<0.001）和-0.35kg/m²（p<0.001），平均糖化血红蛋白（HbA1c）水平从8.45±1.19%改善至7.30±0.92%（-1.15±1.08%；p<0.001）。空腹血糖平均水平和血糖变异性显著降低。
该研究的基线数据强调了德国2型糖尿病患者需要更早强化抗糖尿病治疗。研究结果表明，在德国糖尿病护理体系中，起始地特胰岛素基础胰岛素治疗能够显著改善糖化血红蛋白，而不会增加低血糖和/或体重增加的风险。
