口服降糖药治疗失效的2型糖尿病患者使用地特胰岛素的安全性和有效性SOLVE^TM国际临床观察研究中国结果报道

The safety and effectiveness of once daily detemir in patients with type 2 diabetes previously failing oral agents： the Chinese cohort from SOLVETM observational study

目的诺和平1天1次注射研究（Study of Once—daily LeVEmir@，SOLVE^TM）是一项为期24周、多中心、开放的观察性研究，旨在评价口服降糖药治疗失效的2型糖尿病患者中起始加用每天1次地特胰岛素（诺和平@）治疗后的安全性和有效性。方法本研究来源于SOLVE^TM国际研究的中国结果。共有3272例使用VI服降糖药治疗失效的2型糖尿病患者纳入本研究。参与研究的医生处方地特胰岛素，并在基线和治疗后12周、24周分别收集患者的临床数据，以评价药物的安全性和疗效。结果人选的3272例患者年龄（56．2±10．8）岁，糖尿病病程（7．1±5．2）年，基线BMI（25．3±3．3）kg／m。。治疗期间未观察到重度低血糖事件和夜间重度低血糖事件。治疗24周后，糖化血红蛋白（HbA1C）从基线的（8．33±1．69）％下降到（7．16±1．18）％，空腹血糖（FPG）从（9．52±2．59）mmol／L下降到（6．84±1．42）mmol／L，全天7个时点血糖全面改善，HbA1C〈7％的患者达标率为49．1％。患者平均体重下降0．15kg。结论VI服降糖药失效的2型糖尿病患者，起始加用1天1次地特胰岛素治疗未观察到重度低血糖事件，同时有效改善血糖控制水平，提高治疗达标率，且对体重影响为中性。

Objective Study of Once-daily LeVEmir （ SOLVE^TM ） was a 24-week international observational study to evaluate the safety and effectiveness of initiating once-daily insulin detemir （Levemir） as add-on therapy in patients with type 2 diabetes mellitus （T2DM） who failed treatment of oral anti-diabetic drugs （OAD）. Methods The present study was derived from the data of Chinese cohort. A total of 3272 patients with T2DM failing OAD were enrolled in the study. Determir were prescribed to the patients by the decision of the physician. Clinical data were collected at baseline, week 12 and week 24 to evaluate the safety and effectiveness of detemir. Results The age of the patients was （ 56. 2 ± 10. 8 ） years with a diabetes duration of（7.1 ± 5.2 ） years. Their BMI was （ 25.3 ± 3.3 ） kg/m^2. No patient experienced any major or nocturnal hypoglycaemic event during the study. After 24 weeks of treatment, the glycosylated hemoglobin Alc（HbAlc） decreased from （8. 33 ± 1.69）% to （7. 16 ± 1.18）% with a mean change of - 1.17%, the fasting plasma glucose decreased from （ 9. 52 ± 2. 59 ） mmol/L to （ 6. 84 ± 1.42 ） mmol/L with a mean change of -2.7 mmol/L, and the 7-point blood glucose profile improved overall. Totally 49. 1% of patients achieved HbAlc 〈 7%. The mean body weight decreased by 0. 15 kg. Conclusions Insulin detemir administered once daily as add-on therapy in patients with T2DM failing OAD regimen significantly reduces the risk of major hypoglycemia, improves glycemic control, increases the percentage of patients achieving treatment target with neutral effect on body weight.