| Objective: To observe and analyze the effect on combination therapy with dapagliflozin and insulin on clinical indexes of patients with type 2 diabetes,and to evaluate its efficacy and safety,in order to provide more and better options for the treatment of type 2 diabetes mellitus.Method: To collect the clinical data of patients with type 2 diabetes who met the inclusion criteria from the endocrinology department of the Second Hospital of Jilin University from June 2017 to December 2017.They were randomly divided into two groups,dapagliflozin group and control group.Dapagliflozin group was treated with dapagliflozin(10 mg once daily)in combination with insulin therapy.The control group was treated with insulin only.Two groups of the patients were advised to follow the diet of diabetes mellitus,exercise moderately,maintain emotional stability and adjust insulin dose according to the doctor’s advice,so that the fasting plasma glucose and 2h plasma glucose in both groups were stable within the target of glycemic control.After the 12-week follow-up point,the observations were recorded and the dapagliflozin group was randomly divided into subgroup 1(only insulin therapy was used with dapagliflozin no longer used after the 12-week follow-up point),subgroup 2(continued with dapagliflozin to 24 weeks).We continued to follow up the observation indexes recorded in the control group,subgroup 1 and subgroup 2 to 24 weeks.The indicators were observed at each time point as follows: fasting plasma glucose,2h plasma glucose,glycosylated hemoglobin A1 c,Body Mass Index,fasting insulin,triglyceride,total cholesterol,insulin dose and the hypoglycaemic events.The homeostasis model assessment-insulin sensitivity index and homeostasis model assessment-insulin resistance index were calculated.Result: A total of 120 patients in this study were followed up,60 in the dapagliflozin group and 60 in the control group.We collected the clinical indicators of the two groups at the 12-week follow-up point.There was no statistical difference between the two groups at the baseline(p>0.05).The fasting plasma glucose,2h plasma glucose and glycosylated hemoglobin A1 c in the control group and the dapagliflozin group decreased at the 12-week follow-up point from baseline(p<0.05),but there was no statistical difference between two groups(p>0.05).There was no statistical difference in Body Mass Index at the 12-week follow-up point from baseline in the control group(p>0.05),while the Body Mass Index of the dapagliflozin group decreased from baseline at the 12-week follow-up point(p<0.05),and the result was statistically significant compared with the control group(p<0.05).The homeostasis model assessment-insulin sensitivity index increased in both the control group and the dapagliflozin group at the 12-week follow-up point compared to the baseline(p<0.05),and the increase was even greater in the dapagliflozin group(p<0.05).The homeostasis model assessment-insulin resistance index decreased in both the control group and the dapagliflozin group at the 12-week follow-up point compared to the baseline(p<0.05),and the decrease was even greater in the dapagliflozin group(p<0.05).The triglyceride and total cholesterol of the control group and the dapagliflozin group were lower than the baseline at the 12-week follow-up point(p<0.05),but there was no statistical difference between the two groups(p>0.05).There was no statistical difference in insulin dose between the control group and the baseline at the 12-week follow-up point(p>0.05),the insulin dose in the dapagliflozin group decreased from baseline at the 12-week follow-up point(p<0.05),and the result was statistically significant compared with the control group(p<0.05).From the beginning of observation to the 12-week follow-up point,there was no statistical difference in the incidence of hypoglycemia between the control group and dapagliflozin group(p>0.05).At the 12-week follow-up point,the dapagliflozin group was randomly divided into subgroups 1(30 cases)and subgroups 2(30 cases).Patients in the control group,subgroup 1 and subgroup 2 were followed up for 24 weeks to collect relevant clinical indicators.There was no statistical difference between the three groups at the baseline(p>0.05).The fasting plasma glucose,2h plasma glucose and glycosylated hemoglobin A1 c in the control group,subgroup 1 and subgroup 2 decreased from baseline at all follow-up points(p<0.05),but there was no statistical difference between the groups(p>0.05).There was no statistical difference in Body Mass Index between the control group and the baseline at all follow-up points(p>0.05).Subgroup 1 and subgroup 2 showed a decrease in Body Mass Index at all follow-up points(p<0.05),with a statistical difference compared with the control group(p<0.05),but there was no statistical difference between subgroup 1 and subgroup 2(p>0.05).The homeostasis model assessment-insulin sensitivity index of the control group,subgroup 1 and subgroup 2 increased at each follow-up point compared with the baseline(p<0.05).At each follow-up point,the increase of the homeostasis model assessment-insulin sensitivity index in subgroup 1 and subgroup 2 was greater than that in the control group(p<0.05).The homeostasis model assessment-insulin sensitivity index in subgroup 2 at the 24-week follow-up point was statistically higher than that at the 12-week follow-up point(p<0.05),the difference was statistically significant compared with that in subgroup 1(p<0.05).The homeostasis model assessment-insulin resistance index of the control group, subgroup 1 and subgroup 2 decreased at each follow-up point compared with the baseline(p<0.05).At each follow-up point,the decrease of the homeostasis model assessment-insulin resistance index in subgroup 1 and subgroup 2 was greater than that in the control group(p<0.05).The homeostasis model assessment-insulin resistance index in subgroup 2 at the 24-week follow-up point was statistically lower than that at the 12-week follow-up point(p<0.05),the difference was statistically significant compared with that in subgroup 1(p<0.05).The triglyceride and total cholesterol in the control group,subgroup 1 and subgroup 2 were all lower than the baseline at each follow-up point(p<0.05),and the triglyceride and total cholesterol at the 24-week follow-up point were lower than that at the 12-week follow-up point(p<0.05),but there was no statistical difference between the groups(p>0.05).The insulin dose in the control group was lower than the baseline at the 24-week follow-up point(p<0.05).The insulin dose in subgroup 1 and subgroup 2 decreased from the baseline at each follow-up point(p<0.05),and there was a statistical difference compared with the control group(p<0.05).The insulin dose of subgroup 2 decreased at the 24-week follow-up point compared with the 12-week follow-up point(p<0.05),and there was a statistical difference compared with subgroup 1(p<0.05).From the beginning of observation to the 24-week follow-up point,the incidence of hypoglycemia in the control group,subgroup 1 and subgroup 2 was compared,and there was no statistical difference between the groups(p>0.05).Conclusion: For the patients with type 2 diabetes,dapagliflozin combined with insulin is superior to insulin alone in the treatment of type 2 diabetes.On the basis of stable control of blood sugar,it can significantly reduce the dose of insulin and play a role in weight loss.It can improve insulin resistance and repair islet cell function to a certain extent with,and the security is good.For the patients with type 2 diabetes,compared with only 12 weeks of treatment,the combination of dapagliflozin and insulin for 24 weeks can further improve the function of islet cells and reduce the dose of insulin injection,but there is no significant difference in other indicators. |
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