Objective To evaluate efficacy and safety of domestic Nateglinide tablet in comparison with domestic Repaglinide in Type 2 diabeties. Methods A multi-centre, double-blind, dummy trial was conducted.Two hundred and thirty type 2 diabetic patients recuited from 5 clinical centers were randomly allocated into Group A (domestic Repaglinide, 1.0 mg tid, n =115) and Group B (domestic Nateglinide, 90 mg tid, n =115).The trial consisted of a 4 weeksequilibrated period followed by 12 weeks treatment course. Results Ninety seven percent of patients(223) completed the trial (110 in Group A and 113 in Group B). The mean of fasting blood glucose (FBG) in both Group A and B was decreased statistically (P＜ 0.000 1) after 2, 6 and 12 weeks duration. At week 12, the mean FBG in Group A and B was reduced by 1.68±1.81 mmol/L (17.27%) and 1.17±1.67 mmol/L (12.53%) respectively with statistically significant difference between the two groups (P=0.017 7). The mean of 120 minutes postprandial blood glucose (PBG) also lowered markedly in 2, 6, and 12 weeks in both groups. At the end of therapy, PBG of 30, 60, 120 minutes were reduced significantly, mean of 120 minutes PBG was reduced 3.95±3.25 mmol/L (26.12%), and 3.81±3.05 mmol/L (26.22%) respectively in Group A and B , the differences in reduction between Group A and B had no statistical significance (P =0.726 9). In Group A and B, the mean of Alc was reduced significantly after 12 weeks duration. At week 12, the mean of Alc in Group A and B was lowered by 1.21% and 0.68% respectively, with statistical difference between the two groups (P =0.002 3). Though fasting insulin level in both groups had no change after 12 weeks duration, the insulin level at 30, 60 and 120 min increased significantly in both groups (P＜0.000 1). It suggested that both Nateglinide and Repaglinide promoted insulin secretion in early phase with maximal value at 60 min in Repaglinide group and 30 min in Nateglinide group, respectively. The adverse reaction rate in Group A including hypoglycemic reaction, thrombocytopenia and recrudescence of HBV was 4.5% when compared to only one case of thrombocytopenia in Group B (0.87%). Conclusions Both domestic Nateglinide and Repaglinide have similar effect on reducing postprandial blood glucose, but Repaglinide has ber effect on reducing FBG and A1c than Nateglinide. The results suggest that both domestic Nateglinide and Repaglinide are safe and generally well-tolerated in type 2 diabetic patients.
摘要:目的: 觀察瑞格列奈、阿卡波糖聯合治療老年性2型糖尿病患者的臨床療效及安全性。 方法 :觀察58例2型糖尿病患者服用瑞格列奈及阿卡波糖,療程12周,監測治療前后空腹及餐后2 h血糖(FBG、PBG)、糖化血紅蛋白(HbAlc)、肝功、腎功。 結果 :FBG、PBG及HbAlc較治療前顯著下降(Plt;005),尤其是餐后血糖更為明顯(Plt;001)。無一例肝腎功能損害,也無嚴重低血糖及其它嚴重不良反應發生。 結論 :瑞格列奈聯合阿卡波糖治療2型糖尿病降糖作用確切,而且安全性、耐受性良好。Abstract: Objective: To observe the clinical efficacy and safety of combined treatment of repaglinide and acarbose in aged patients with diabetes type 2 Methods : After oral administration of repaglinide and acarbose for 12 weeks, 58 patients with type 2 diabetes were observed. The concentrations of fasting blood glucose (FBG), 2 h postprandial blood glucose (PBG), glycosylated hemoglobin (HbAlc), liver and kidney functions were monitored before and after treatment. Results : The levels of FBG, PBG and HbAlc were significantly decreased compared with pretreatment (Plt;005), especially PBG (Plt;001). No case of liver and kidney dysfunction was found, without serious hypoglycemia and other serious adverse events as well. Conclusion : Repaglinide and acarbose have the precise function in the treatment of type 2 diabetes, with good security and good tolerance.
目的:觀察胰島素聯合瑞格列奈對磺脲類降糖藥治療失敗的2型糖尿病患者的療效。方法:75例磺脲類治療失敗的2型糖尿病患者隨機分為兩組,分別給予胰島素及胰島素聯合瑞格列奈治療,療程12周。分別檢測兩組患者治療前后FBG、2 h PBG和HbA1C水平,并記錄胰島素用量,評價胰島素聯合瑞格列奈的臨床療效。結果:兩組患者血糖和HbA1C均控制良好,但與對照組相比,胰島素聯合瑞格列奈組患者餐后血糖下降更為明顯,且胰島素用量較對照組明顯下降(Plt;005)。結論:胰島素聯合瑞格列奈對磺脲類藥物治療失敗2型糖尿病患者具有較好的療效,同時可減少胰島素用量。
ObjectiveTo compare the efficacy of sitagliptin plus glargine insulin versus repaglinide plus glargine insulin in the treatment of Type-2 diabetes mellitus (T2DM). MethodsA total of 140 T2DM patients who were inadequately controlled by oral anti-diabetic agents from January 2011 to December 2012 were divided into sitagliptin plus glargine insulin group (observation group) or repaglinide plus glargine insulin group (control group). The duration of treatment was 12 weeks. Fasting blood glucose (FBG), 2h plasma glucose (2hPG), glycated haemoglobin (HbA1c), body max index (BMI) and dose of insulin as well as hypoglycemia events were recorded and analyzed. ResultsAfter treatment, FBG, 2hPG, and HbA1c were significantly decreased in both groups (P<0.05). HbA1c targeting rate was 88.3% in the observation group and 87.8% in the control group. Compared with the control group, the observation group used 12.1% less dosage of insulin, and had decreased BMI and low incidence of hypoglycemia. ConclusionSitagliptin plus glargine insulin can effectively control blood glucose and body weight with low incidence of hypoglycemia and much less insulin dosage under the same HbA1c targeting rate. Sitagliptin plus glargine insulin is a good combination therapy for the treatment of T2DM.