Li Jiling, Feng Zhengping, Li Qifu, He Yan, Zhao Changhong, He Jun
Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, P.R. China.
Exp Ther Med. 2014 Jul;8(1):147-152. doi: 10.3892/etm.2014.1688. Epub 2014 Apr 24.
In the present study, the clinical efficacy and safety of administering insulin glargine to early type 2 diabetes (T2D) mellitus patients with a high risk for cardiovascular disease were assessed. A total of 42 early T2D patients at a high risk for cardiovascular disease were randomly divided into an insulin-glargine group and a standard-care group. The patients in the insulin-glargine group received oral antidiabetic agents plus glargine once a day via a subcutaneous injection. The patients in the standard-care group were administered oral antidiabetic agents according to the diabetic treatment guidelines. The median follow-up period was 6.4 years. Comparisons were made between the two groups with regard to levels of plasma glucose, glycosylated hemoglobin (HbA1c) and plasma lipids, the homeostasis model assessment-insulin secretion index (HOMA-β) and HOMA-insulin resistance index (HOMA-IR), as well as the incidence of hypoglycemia, adverse cardiovascular events and body mass index (BMI). The fasting plasma glucose level in the insulin-glargine group was significantly lower than that observed in the standard-care group. However, the levels of 2-h postprandial glucose, HbA1c and plasma lipids, as well as the BMI, were similar when comparing the two groups. Although the level of the HOMA-β did not differ between the two groups, the level of HOMA-IR in the insulin-glargine group was significantly lower than that observed in the standard-care group. During the follow-up period, the incidence of hypoglycemia in the insulin-glargine group was significantly higher when compared with the standard-care group, however, no significant difference in the incidence of adverse cardiovascular events was observed. Therefore, the results of the present study indicated that insulin glargine may effectively achieve glycemic control and improve insulin resistance without increasing the risk for cardiovascular events in early T2D patients that were considered to be at a high risk for cardiovascular disease.
在本研究中，评估了对心血管疾病高危的早期2型糖尿病（T2D）患者给予甘精胰岛素的临床疗效和安全性。总共42例心血管疾病高危的早期T2D患者被随机分为甘精胰岛素组和标准治疗组。甘精胰岛素组患者接受口服抗糖尿病药物加每日一次皮下注射甘精胰岛素。标准治疗组患者根据糖尿病治疗指南给予口服抗糖尿病药物。中位随访期为6.4年。比较了两组之间的血糖、糖化血红蛋白（HbA1c）和血脂水平、稳态模型评估胰岛素分泌指数（HOMA-β）和HOMA胰岛素抵抗指数（HOMA-IR），以及低血糖发生率、不良心血管事件和体重指数（BMI）。甘精胰岛素组的空腹血糖水平显著低于标准治疗组。然而，比较两组时，餐后2小时血糖、HbA1c和血脂水平以及BMI相似。虽然两组之间的HOMA-β水平没有差异，但甘精胰岛素组的HOMA-IR水平显著低于标准治疗组。在随访期间，甘精胰岛素组的低血糖发生率与标准治疗组相比显著更高，然而，不良心血管事件的发生率没有观察到显著差异。因此，本研究结果表明，甘精胰岛素可以有效实现血糖控制并改善胰岛素抵抗，而不会增加被认为心血管疾病高危的早期T2D患者发生心血管事件的风险。
