| Objective:To evaluate the efficacy and safety of insulin degludec U100 and insulin glargine U100 in the treatment of type 2 diabetes mellitus(T2DM),and explore the efficacy,safety and feasibility of insulin degludec every other day.Methods:A total of 181 T2DM patients who met the inclusion criteria and voluntarily enrolled in this study were collected in the outpatient or inpatient department of the Endocrinology Department of the North Sichuan Medical College affiliated Hospital from February 2019 to December 2020.Among them,31 patients fell off,and 150 patients were finally collected,including insulin degludec every other day group of 30 cases(every other day injected insulin degludec U100,group A),insulin degludec once a day group of 60 cases(once a day injected insulin degludec U100,group B),and insulin glargine once a day group of 60 cases(once a day injected insulin glargine U100,group C).According to the condition combined with other hypoglycemic drugs,the subjects underwent self-monitoring Of Blood Glucose(SMBG)once a week,and were messured for fingertip blood glucose at least one day(fasting and 2 hours after three meals).And the blood glucose should be measured when hypoglycemic symptoms were present and conditions were available.The subjects were followed up by telephone or network once a week to adjust the treatment options and collect data for three months.The general information,blood glucose,blood glucose fluctuation,incidence of hypoglycemia,weight change,other adverse events,insulin dose and injection omission of the subjects among the three groups were compared.SPSS23.0 and Excel were used for statistical analysis,and P<0.05 was considered statistically significant.Results:1.The study eventually collected 150 patients with T2DM,including 88 males(58.7%)and 62 females(41.3%),with a mean age of(53±11)years and duration of diabetes 10(5-15)years.2.There were no significant difference in gender,family history,hypertension,hyperlipidemia,hyperuricemia,coronary heart disease,stroke,heart failure,anxiety and depression,tumor,elevated transaminase,chronic kidney disease(CKD),diabetic retinopathy(DR),diabetic peripheral neuropathy(DPN),diabetic peripheral angiopathy(PAD),diabetic autonomic neuropathy(DAN),Diabetic foot(DF),ketosis,hypoglycemia and the use of hypoglycemic drugs among the three groups(P>0.05).The age of group A were younger than that of group B and group C,and the difference was statistically significant(P<0.05).The duration of diabetes in group A were relatively shorter than that in group B and group C,and P value was close to 0.05.3.Before and after the trial,there were no significant difference in Weight,body mass index(BMI),waist circumference(WC),waist height ratio(WHtR),systolic blood pressure(SBP),diastolic blood pressure(DBP),postprandial 2-hour blood glucose(2 hours plasma glucose,2hPG),glycosylated hemoglobin(glycosylated hemoglobin,HbA1c),total cholesterol(TC),triglyceride(TG),low density lipoprotein cholesterol(LDL-C),high density lipoprotein cholesterol(HDL-C),glutamic oxaloacetic transaminase(AST),glutamic pyruvic acid(ALT),glutamyl transpeptidase(GGT),albumin(ALB),creatinine(Cr),glomerular filtration rate(eGFR),urea nitrogen(BUN),uric acid(UA)and hemoglobin(Hb)among the three groups(P>0.05).4.After the trail,the HbA1c attainment rates of among the three groups was similar,and there was no significant difference among the three groups(P>0.05).The △HbA1c of group A and group B were higher than that of group C,and the difference was statistically significant(P<0.05).There was no significant difference in △HbA1c of beteen group A and group B(P>0.05).5.There were no significant difference in FPG among the three groups before the trail.After the trail,the FPG in group A and group B were lower than that in group C(P<0.05),however the difference in FPG in group A and group B was not statistically significant(P>0.05).There was significant difference in △FPG between group B and group C(P<0.05),however between group A and group B,group A and group C there were no significant difference in AFPG.There was significant difference in FPG variability between group B and C(P<0.05),however there were no significant difference in FPG variability between group A and group B,group A and group C(P>0.05).6.Before and after the trail,there were no significant difference in the mean value of blood glucose,the standard deviation of blood glucose level(SDBG)and the maximum fluctuation range of blood glucose(LAGE)among the three groups at 4 o’clock(P>0.05).There were no significant difference in the mean blood glucose,SDBG and LAGE at 8 o’clock SMBG of 24 hours before the first injection in some subjects in group B and group C(P>0.05).The mean blood glucose of 24 hours after the first injection had statistical difference(P<0.05),however there were no significant difference in the SDBG and LAGE between the two groups(P>0.05).There were statistical differences in mean blood glucose and SDBG on the 10th day after treatment between the two groups(P<0.05),however no statistical differences in LAGE(P>0.05).7.The incidence of overall hypoglycemia and nocturnal hypoglycemia in group B were lower than that in group C,and the difference was statistically significant(P<0.05),while there were no statistical difference in group A and group B,group A and group C(P>0.05).No serious hypoglycemic events occurred in the three groups.8.At the end of the trial,the weight gain of group B was larger than that of group C,and the difference was statistically significant(P<0.05).9.During the trial,there were no significant difference in other adverse reactions among the three groups(P>0.05).Upper respiratory tract infection,injection site adverse reactions,digestive tract reactions,lower limb edema and major adverse cardiovascular events(Major Adverse Cardiovascular Events,MACE)were mainly observed.10.At the end of the trial,the daily dose and total dose of insulin in group A were lower than those in groups B and C,and the difference was statistically significant(P<0.05).11.The omission of insulin injection in all the three groups was not statistically significant(P>0.05),with the omission frequency ranging from one to three times or more.Conclusion:1.In some T2DM patients,the efficacy and safety of insulin degudec U100 every two days are similar to insulin degudec U100 and insulin glargine U100 once a day.Those who are willing to reduce the frequency of injections may consider a trial.2.The hypoglycemic effect of insulin degludec U100 is similar inferior to that of insulin glargine U100,and the blood glucose fluctuation of insulin degludec U100 may be smaller.3.The risk of overall hypoglycemia and nocturnal hypoglycemia with insulin degludec U100 are lower than that with insulin glargine U100. |
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