谷赖胰岛素联合甘精胰岛素治疗口服降糖药物继发性失效的2型糖尿病的临床研究

Clinical trial of insulin glulisine combined with insulin glargine in the treatment of type 2 diabetes patients with secondary failure to oral hypoglycemia agents

目的比较谷赖胰岛素(GLU)或门冬胰岛素(ASP)联合甘精胰岛素(GLA)治疗口服降糖药物继发性失效的2型糖尿病(T2DM)的临床疗效及安全性。方法将120例口服降糖药物继发性失效的T2DM随机分为对照组60例和试验组60例。对照组予以皮下注射ASP,起始剂量0.8 U·kg^(-1)·d^(-1),每日三餐前0~10 min+皮下注射GLA,起始剂量0.2 U·kg^(-1)·d^(-1),qd;试验组予以皮下注射GLU,起始剂量0.8 U·kg^(-1)·d^(-1),每日三餐前0~10 min+皮下注射GLA,起始剂量0.2 U·kg^(-1)·d^(-1),qd。2组患者均治疗12周,其中前2周住院治疗。比较2组患者治疗2周后的血糖达标例数和时间天数,治疗12周后的糖化血红蛋白(Hb A1c)变化,以及药物不良反应的发生情况。结果试验组和对照组三餐的餐后2 h血糖(2 h PG)均同时达标所需时间天数分别为(10.01±1.99)d和(10.93±1.52)d,例数分别为54和47例,差异均有统计学意义(均P<0.05)。试验组和对照组空腹血糖、中晚餐的餐前血糖与三餐的2 h PG均同时达标所需时间天数分别为(10.31±1.04)d和(11.03±1.38)d,例数分别为48和40例,差异均有统计学意义(均P<0.05)。治疗12周后,试验组和对照组Hb A1c分别为(6.78±0.59)%和(7.07±0.49)%,差异无统计学意义(P>0.05)。2组患者的药物不良反应以低血糖事件为主,试验组和对照组的低血糖事件发生率分别为30.00%和25.00%,差异无统计学意义(P>0.05)。结论 GLU联合GLA治疗口服降糖药物继发性失效的T2DM的临床疗效和安全性与ASP联合GLA相似,但前者控制餐后血糖明显优于后者。

Objective To compare the clinical efficacy and safety of insulin glulisine（ GLU） and insulin aspart（ ASP） combined with insulin glargine（ GLA） in type 2 diabetes patients（ T2DM） with secondary failure to oral hypoglycemic agents. Methods One hundred and twenty cases of T2 DM with secondary failure to oral hypoglycemia agents were randomly divided into control group（ n = 60 cases） and treatment group（ n = 60 cases）. The control group received subcutaneous injection of ASP before 0-10 min three meals daily, and the treatment group received subcutaneous injection of GLU before 0-10 min three meals daily. The two groups were treated with subcutaneous injection of GLA,once daily. The initial dose of ASP and GLU were 0. 8 U·kg-1·d-1,and the initial dose of GLA was 0. 2 U · kg-1·d-1. Two groups ofpatients were hospitalized for 2 weeks. The changes of blood glucose,cases and days of blood glucose of achieving target were compared after treatment of hospitalization. The improvement of Hb A1 c and the frequency of hypoglycemia were observed after treatment of 12 weeks. Results The days of 2-hour postprandial blood glucose（ 2 h PG） of achieving target in the treatment group and the control group were（ 10. 01 ± 1. 99） d and（ 10. 93 ± 1. 52） d with 57 cases and 47 cases,and the days of fasting plasma glucose,postprandial blood glucose and 2 h PG of achieving target were（ 10. 31 ± 1. 04） d and（ 11. 03 ± 1. 38） d with 48 cases and 40 cases（ all P〈0. 05）. After treatment 12 weeks,the HbA1c in treatment and control groups were（ 6. 78 ± 0. 59） % and（ 7. 07 ± 0. 49） % without significant difference（ P〈0. 05）. During treatment of 12 weeks,the adverse drug reactions in the two groups were mainly hypoglycemic events,the incidence of hypoglycemia in the treatment group was 30. 00%,and 25. 00% in the control group,the difference was not statistically significant（ P〈0. 05）. Conclusion Both GLU combined with GLA or ASP combined with GLA have similar efficacy and safety for T2 DM with secondary failure to oral hypoglycemic agents. GLU combined with GLA is more rapid in controlling 2 h PG of these patients.