Li Wei, Ping Fan, Xu Lingling, Zhang Huabing, Dong Yaxiu, Li Hongmei, Sun Qi, Li Yuxiu
Department of Endocrinology, Key Laboratory of Endocrinology of National Health and Family Planning Commission, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Endocrinology, China Meitan General Hospital, Beijing, China.
Diabetes Ther. 2018 Aug;9(4):1605-1614. doi: 10.1007/s13300-018-0462-9. Epub 2018 Jun 27.
To investigate the relative contribution rates of basal hyperglycemia (BHG) and postprandial hyperglycemia (PPHG) to overall hyperglycemia in patients with type 2 diabetes mellitus (T2DM) treated with insulin lispro mix 25 and 50 (LM25 and LM50) as evaluated by continuous glucose monitoring (CGM).
Eighty-one T2DM patients treated with premixed human insulin 70/30 (PHI70/30) were randomly divided into two groups and received a crossover protocol. In the first 16-week stage, one group received LM25 twice daily, the other group received LM50 twice daily. In the second 16-week stage, the two groups exchanged therapeutic regimen. Glycosylated hemoglobin (HbA) measurement and CGM were performed at enrollment and at the end of each treatment stage.
BHG's contribution rate increased with increasing HbA (from 34.5% to 60.8%). PPHG's contribution rates in the LM50 regimen were significantly lower than those in LM25 and PHI70/30 regimens at HbA levels < 7.5%. Compared with LM50, LM25 shows a significant difference in reducing HbA in the subgroup with baseline HbA ≥ 8.5% (ΔHbA LM25 vs. LM50 - 0.6 ± 0.1% vs. 0.3 ± 0.1%, p < 0.05).
For T2DM patients treated with premixed insulin analogues, postprandial hyperglycemia played a major role in the subgroup of patients with HbA < 8.5%, while fasting hyperglycemia became the major contributor to overall hyperglycemia in the subgroup of patients with HbA ≥ 8.5%.
Chinese Clinical Trial Registry Identifier ChiCTR-TTRCC-12002516.
Lilly Suzhou Pharmaceutical Co., Ltd. (Shanghai Branch, China) and National Key Program of Clinical Science of China (WBYZ2011-873).
通过持续葡萄糖监测（CGM）评估，探讨基础高血糖（BHG）和餐后高血糖（PPHG）对接受赖脯胰岛素25和50混合制剂（LM25和LM50）治疗的2型糖尿病（T2DM）患者总体高血糖的相对贡献率。
81例接受预混人胰岛素70/30（PHI70/30）治疗的T2DM患者被随机分为两组并接受交叉方案。在第一个16周阶段，一组每日两次接受LM25治疗，另一组每日两次接受LM50治疗。在第二个16周阶段，两组交换治疗方案。在入组时和每个治疗阶段结束时进行糖化血红蛋白（HbA）测量和CGM。
BHG的贡献率随HbA升高而增加（从34.5%增至60.8%）。在HbA水平<7.5%时，LM50治疗方案中PPHG的贡献率显著低于LM25和PHI70/30治疗方案。与LM50相比，在基线HbA≥8.5%的亚组中，LM25在降低HbA方面显示出显著差异（LM25与LM50相比，ΔHbA为 - 0.6±0.1%对0.3±0.1%，p<0.05）。
对于接受预混胰岛素类似物治疗的T2DM患者，餐后高血糖在HbA<8.5%的患者亚组中起主要作用，而空腹高血糖在HbA≥8.5%的患者亚组中成为总体高血糖的主要贡献者。
中国临床试验注册中心标识符ChiCTR-TTRCC-12002516。
礼来苏州制药有限公司（中国上海分公司）和中国国家临床科学重点项目（WBYZ2011-873）。
