Kvapil M
Vnitr Lek. 2013 Sep;59(9):800-6.
The RESOLUTE was a multinational, non interventional, 6 month prospective observational project evaluating in clinical practice, whether patients with type 2 diabetes mellitus (T2DM) inadequately controlled with detemir in combination with oral antidiabetic drugs (OADs) may benefit from switching to glargine. In Czech Republic 200 patients, for whom the participating physician according to their own consideration, had decided to prescribe insulin glargine in replacement of insulin detemir, were included in this project.
The primary endpoint was to assess the change in HbA1c over the 6- month period in T2DM patients treated with insulin glargin after switch from insulin detemir. Secondary endpoints included the evaluation of the change in fasting plasma glucose, insulin dose, body weight over the 6-month period after starting insulin glargine , the evaluation of the number of hypoglycemia during the last month of therapy which each basal insulin and the frequency of adverse events (AE) during treatment with insulin glargine.
Insulin glargine therapy resulted in a statistically significant improvement in compensation of diabetes characterized by a mean HbA1c decrease of about 0.82 (± 0.93) % (p < 0.001) and a mean decrease of recorded fasting glycemia about 1.91 (± 2.81) mmol/ l (p < 0.001). No significant change in the mean body weight was recorded du-ring study [+0.12 (± 2.98) kg; p = NS]. The mean daily insulin glargine dose used at the end of the observation increased in comparison with last mean daily dose of insulin detemir [+2.99 (± 7.54) U; p < 0.001]. The improvement in glycemic control was accompanied by low risk of hypoglycemia. The percentage of patients with documented symptomatic (5.0%), nocturnal (2.5%) and severe (0%) hypoglycemia in the last month of glargine therapy was consistently lower compared with the last month of previous treatment with detemir (14.6%, 9.5% and 2.5%, respectively). Other adverse events were reported in 3.0% of patients on glargine therapy. No adverse events were considered as adverse event related to insulin glargin treatment. No serious adverse or no serious adverse events leading to treatment discontinuation or death were documented during the course of the study.
Under reallife conditions, switching from insulin detemir to once daily insulin glargine in poorly controlled T2DM patients resulted in clinically relevant improvements in glycemic control without an increase in weight and hypoglycemia risk.
RESOLUTE是一项多中心、非干预性、为期6个月的前瞻性观察项目，旨在临床实践中评估，使用地特胰岛素联合口服降糖药（OADs）血糖控制不佳的2型糖尿病（T2DM）患者改用甘精胰岛素是否有益。在捷克共和国，200名患者被纳入该项目，参与项目的医生根据自身判断决定为他们开具甘精胰岛素以替代地特胰岛素。
主要终点是评估T2DM患者从地特胰岛素改用甘精胰岛素治疗6个月期间糖化血红蛋白（HbA1c）的变化。次要终点包括评估开始使用甘精胰岛素后6个月期间空腹血糖、胰岛素剂量、体重的变化，评估每种基础胰岛素治疗最后1个月期间低血糖的发生次数以及甘精胰岛素治疗期间不良事件（AE）的发生频率。
甘精胰岛素治疗使糖尿病病情得到了具有统计学意义的改善，糖化血红蛋白平均降低约0.82（±0.93）%（p<0.001），记录的空腹血糖平均降低约1.91（±2.81）mmol/l（p<0.001）。研究期间体重均值无显著变化[+0.12（±2.98）kg；p=无统计学意义]。观察结束时使用的甘精胰岛素平均每日剂量相较于地特胰岛素的最后平均每日剂量有所增加[+2.99（±7.54）U；p<0.001]。血糖控制的改善伴随着低血糖风险较低。甘精胰岛素治疗最后1个月记录的有症状低血糖（5.0%）、夜间低血糖（2.5%）和严重低血糖（0%）患者的百分比始终低于地特胰岛素先前治疗的最后1个月（分别为14.6%、9.5%和2.5%）。甘精胰岛素治疗的患者中有3.0%报告了其他不良事件。没有不良事件被认为与甘精胰岛素治疗相关。研究过程中未记录到导致治疗中断或死亡的严重不良事件。
在现实生活条件下，血糖控制不佳的T2DM患者从地特胰岛素改用每日一次的甘精胰岛素可使血糖控制得到临床相关改善，且不会增加体重和低血糖风险。
