利格列汀联合二甲双胍治疗2型糖尿病疗效与安全性初步研究

Effect of Combination of Linagliptin and Metformin on Glycaemic Control and Safety in Patients with Type 2 Diabetes: a Preliminary Randomized, Double-blind, Placebo-controlled Study

关键词:  利格列汀  二甲双胍  2型糖尿病

Key words:  linagliptin  metformin  type 2 diabetes

摘要:

目的 探讨利格列汀与安慰剂作为二甲双胍的添加治疗对血糖控制不良的2型糖尿病患者的有效性、安全性。方法 15例2型糖尿病患者随机分为2组：5 mg利格列汀联合二甲双胍组(n=10)、安慰剂联合二甲双胍组(n=5)，治疗24周，观察治疗前后2组糖化血红蛋白(HbAlc)、空腹血糖(FPG)、丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、碱性磷酸酶(ALP)、血清肌酐(Scr)、尿白蛋白肌酐比(UACR)、肌酸激酶(CK)、体质指数(BMI)、腰围、收缩压(SBP)、舒张压(DBP)，记录不良事件及低血糖事件。结果 2组HbA1c改变幅度分别为-14.9%，-7.3%(P<0.05)；FPG改变幅度分别为-4.7%，-8.0%(P>0.05)；SBP改变幅度分别为-1.6%，+9.0%(P<0.05)；DBP改变幅度分别为+0.2%，+13.7%(P<0.05)，UACR改变幅度分别为-33.3%，+91.1%(P<0.01)。2组间ALT、AST、ALP、Scr、BMI、腰围改变、不良事件差异均无统计学意义。2组均无低血糖事件。结论 利格列汀联合二甲双胍治疗较二甲双胍单药治疗，降低HbA1c更优，有相似的降低FPG疗效，能适当降低SBP，显著降低UACR。无体质量增加和低血糖风险，是一种安全有效的治疗方法。

Abstract:

OBJECTIVE To observe the effect of combination of linagliptin and metformin on glycaemic control and safety in patients with type 2 diabetes. METHODS In this 24 weeks, double-blind, placebo-controlled study, 15 patients with type 2 diabetes were randomized to 2 groups: 5 mg linagliptin plus metformin group(Group A, n=10), placebo plus metformin group(Group B, n=5). Hemoglobin Alc(HbAlc), FPG, lipid profile, urinary albumin creatinine ratio(UACR), ALT, AST, ALP, Scr, CK, body mass index(BMI), waist circumstance, systolic blood pressure(SBP) and diastolic blood pressure(DBP) were measured. RESULTS The mean decreasing amplitude for HbA1c in the two groups were -14.9%, -7.3%, respectively (P<0.05). FPG decreased by 4.7%, 8.0%, respectively(P>0.05). SBP changed by -1.6%, +9.0%, respectively(P<0.05). And DBP changed by +0.2%, +13.7%(P<0.05). UACR changed by -33.3%, +91.1%(P<0.01). There were no significant difference in lipid profile, ALT, AST, ALP, Scr, CK, BMI, waist circumstance change and adverse events. There were no hypoglycemic events in each group. CONCLUSION Combination of linagliptin and metformin is superior to metformin monotherapy in HbA1c control and has favorable effect on blood pressure and UACR, with a similar lowering FPG capacity and safety profile, without weight gain and risk of hypoglycemia.