| Objective: Taking Metformin Hydrochloride and Repaglinide tablets as positive control,to evaluate the clinical efficacy and safety of Repaglinide and Metformin Hydrochloride Tablets in the treatment of type 2 diabetic patients with poor blood glucose control by using alone biguanide or insulin secretion promoting agents.Methods: This study was a multicenter,randomized,double-blind,three simulation,parallel controlled trial of positive drugs.According to the principle of 1:1 stratified randomization,SAS statistical software was used to generate the random number.The experimental group was divided into 1:1 control group,which consisted of two groups: Repaglinide and Metformin Hydrochloride Tablets(1 mg / 500 mg)+ Metformin tablet mimic tablet + Regolide tablet simulation tablet and Metformin hydrochloride(500 mg)+ Retaglinide(1 mg)+ Repaglinide and Metformin Hydrochloride mimic tablets.The experimental group and the positive control group were divided into two groups for a 4-week period of introduction plus 14 weeks(2-week period of drug adjustment + 12-week period of treatment).After the subjects met the inclusion criteria,they entered the 4-week induction period.After the induction period,they were randomly enrolled into the group and entered the 2-week dose adjustment period.The initial dose was Repaglinide and Metformin Hydrochloride Tablets(1 mg / 500 mg)+ Metformin tablet mimic tablet + Regolide tablet simulation tablet,1 bags / times,bid;or Metformin hydrochloride(500 mg)+ Retaglinide(1 mg)+ Repaglinide and Metformin Hydrochloride mimic tablets,1 bags / times,bid.After 2 weeks of treatment,the dosage was adjusted according to the blood glucose control of the patients.When the FPG was more than 6.1mmol/L,the medication in lunch was added,i.e.tid;when the FPG was between 4.4 and 6.1mmol/L,the initial dosage was maintained;for these two cases,the dosage was adjusted for a stable treatment period of 12 weeks.If the situation of "3.6mmol/L ≤ FPG < 4.4mmol/L" occurs,we should first know whether it is caused by excessive dose.If it is caused by excessive dose,we should reduce the dosage once a day until the FPG recovers to between 4.4-6.1mmol/L,and then resume taking the medicine once a day in the morning and evening.In this case,from the point of reducing the dosage once,we should The treatment period is 12 weeks.After this dose adjustment,the dose will not be adjusted in the later treatment period.The treatment period of the trial was 14 weeks.The patients were visited at baseline,at the end of the lead-in period,and at the end of 2,4,6,10 and 14 weeks after the treatment.They received the examinations required in the protocol,such as: physical examination,vital signs,blood routine,blood biochemistry,urine routine,Hb A1 c,blood insulinositin,FPG,2-hour postprandial blood glucose measurement,blood lipid,liver and kidney function,12 lead ECG,etc.to provide evaluation data on the effectiveness and safety of the test drug.Results: 1.Enrollment results of subjects: 292 cases were planned to be enrolled in this study,and 292 cases were actually enrolled in this study,among which 21 cases fell off,with a fall off rate of 7.19%.Another 16 subjects were not included in PPS because of their deviation from the protocol.In this clinical trial, there were 292 cases of FAS,255 cases of PPS and 292 cases of SS.2.Results of demographic data and baseline comparative analysis: There was no significant difference between the two groups in age,gender,history,combined disease and allergic history at baseline(P > 0.05);there was no significant difference in Hb A1 c,blood glucose,insulin,blood lipid and body weight at baseline(P > 0.05).3.There was no significant difference between the experimental group and the control group in medication compliance,concomitant medication and dosage adjustment(P > 0.05).4.Effectiveness analysis results: Fas: after 14 weeks of treatment,Hb A1 c in the test group and the control group decreased by 1.40 ± 1.15% and 1.23 ± 1.00% respectively compared with the baseline,and there was no significant difference between the two groups(P > 0.05).PPS: 14 weeks later,Hb A1 c in the test group was 1.47 ± 1.12% lower than that in the baseline,and 1.35 ± 0.96% lower in the control group.There was no significant difference between the two groups(P > 0.05).5.Safety analysis results: There was no difference in drug exposure time between the two groups.53 subjects in the experimental group had adverse events,the incidence was 36.30%;41 subjects in the control group had adverse events,the incidence was 28.08%.There was no significant difference between the two groups(P > 0.05).Conclusion: The results showed that: the compound of Retaglinide and Metformin Hydrochloride tablets in the experimental group and the joint use of Retaglinide tablets and Metformin Hydrochloride tablets in the control group can effectively and permanently control blood glucose;adverse events and adverse reactions are similar,clinical application is safe and well tolerated. |
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