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.
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.