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.
Objective To demonstrate the efficacy, tolerability, and safety of domestic Acarbose tablet compared with Glucobay (Acarbose tablet produced by Bayer company) in patients with type 2 diabetic patients. Method A multicenter randomized controlled parallel-group comparison study was conducted. 177 Chinese type 2 diabetic patients were recruited from 4 clinical centers. The patients were divided randomly into domestic Acarbose tablet (A group) or Glucoby (B group) treatment group. The trial consisted of a 2-4 weeks equilibrated period followed by an 8 week course of treatment. Results 165 patients have finished the trial (81 in A group and 84 in B group). After 4 weeks of treatment, the mean of fasting blood glucose (FBG) in A and B group were reduced 1.61 and 2.08 mmol/L respectively, and mean of postprandial blood glucose (PBG) lowered 5.06 and 5.09mmol/L respectively. After 8 weeks of treatment, the mean of FBG were reduced 1.95 and 2.62mmol/L respectively, and mean of PBG lowered 4.88 and 5.98 mmol/L, respectively, and mean of HbA1c were lowered 1.13% and 1.20% respectively in A and B group. The differences in reduction of FBG, PBG, and HbA1c between A and B group were no statistic significance. The serum triglyceride levels and BMI were decreased significantly in both A, B groups. 3 patients who drinking wine during trial on A group had asymptomatic elevations in serum transaminases that normalized in 2 weeks after stopped drinking and Acarbose withdrawal. Flatulence was the most common side effect. Conclusions In this multicenter study, domestic Acarbose tablet 50 mg t.i.d. was an effective, safe, and generally well-tolerated therapy as similar as Glucobay in type 2 diabetic patients.
