格列美脲起始治疗对新诊断2型糖尿病患者的有效性和安全性：GREAT研究亚组分析

Efficacy and safety of glimepiride as initial treatment in newly-diagnosed patients with type 2 diabetes mellitus： sub-group analysis of GREAT study

目的分析格列美脲单药起始治疗对新诊断2型糖尿病患者的有效性和安全性。方法本研究是GREAT研究的一个亚组分析，GREAT研究观察了格列美脲单药起始治疗对中国2型糖尿病患者的有效性和安全性，本分析筛选GREAT研究人群中病程小于6个月且未服用过任何抗糖尿病药物的209例2型糖尿病患者，分析格列美脲治疗16周后，HbA1C、空腹血糖、餐后血糖，稳态模型评估的p细胞功能指数（HOMA—B）、稳态模型评估的胰岛素抵抗指数（HOMA—IR）、体重、腰围较基线的变化，研究终点时HbA1C〈7．0％的达标率并分析低血糖发生情况。结果格列美脲治疗16周后，HbA。从9．21％±1．65％下降到6．69％±0．83％（P〈0．001），空腹血糖从基线的（10．15±2．13）mmol／L降到（7．23±1．50）mmol／L，餐后血糖从（17．21±4．14）mmol／L下降到（11．62±3．34）mmol／L。研究终点时HbA1C〈7．O％的达标率为69．7％。HOMA-β显著升高，从17．21±15．19[11．62（2．90，115．8）]升高到41．13±44．12[28．00（5．1，360．00）]，HOMA—IR显著降低，从2．32±1．90[1．76（0．60，12．80）]降至2．07±1．74[1．63（0．4，12．3）]。报告的症状性低血糖发生率为18．2％，经血糖检测≤3．9mmol／L证实的低血糖发生率为3．8％。结论格列美脲单药起始治疗可有效控制新诊断2型糖尿病患者的血糖，有益于改善胰岛β细胞功能，且安全性总体良好。

Objective To analyze the efficacy and safety of glimepiride treatment as initial monotherapy in newly diagnosed patients with type 2 diabetes mellitus （ T2DM ）. Methods This was a subgroup analysis of the GREAT study, which investigated the efficacy and safety of glimepiride as initial monotherapy in Chinese patients with T2DM. This analysis was performed in 209 patients with disease duration less than 6 months and never received any anti-diabetic drugs. The change of HbA1c, fasting plasm glucose （FPG） , 2 h postprandial blood glucose （ 2hPPG）, homeostasis model assessment for β-cell function index （HOMA-[3）, homeostasis model assessment for insulin- resistance index（HOMA-IR）, the percentage of patients with HbA1c 〈 7. 0% at endpoint and the incidence of hypoglycemia were evaluated after 16-weeks treatment. Results After 16-weeks glimepiride treatment, HbA^c value reduced significantly from baseline to endpoint, the reduction was statistically significant （ 9.21% ± 1.65% to 6.69% ±0.83%, P〈0. 001 ）, 69.7% of the patients achieved HbA1c 〈7. 0% at study endpoint. Gfimepiride-treated patients also achieved a significant improvement in FPG [ from （ 10. 15 ± 2.13 ） mmol/L to （ 7.23 ± 1.50 ） retool/L, P〈 0.001 ] and 2hPPG [ from （ 17.21 ± 4.14 ） mmol/L to （ 11.62 ± 3.34 ）mmoL/L ]. H OMA-β was improved from 17.21 ± 15.19 [ 11.62 （ 2.90, 115.8 ） I to 41.13 ± 44.12 [ 28.00 （ 5.1,360.00 ）], and HOMA-IR was reduced from 2.32± 1.90 [ 1.76 （ 0.60, 12.80 ） I to 2.07 ±_ 1.74 [ 1.63 （ 0.4, 12.3 ） 1- The incidence of all reported symptomatic hypoglycemia was 18.2% , and the incidence of confirmed hypoglycemia was 3.8%. Conclusion This analysis showed that glimepiride treatment as an initial mono-therapy could effectively improve blood glucose control in newly diagnosed patients with T2DM, and the treatment may improve islet [3 cell function, and the safety profile is reasonably good.