| Objective:To compare the dose and the time of insulin glargine 300 U/ml(Gla-300)and 100 U/ml(Gla-100)on fasting blood glucose of inpatient with Type 2 Diabetes Mellitus(T2DM)patients.Methods:This study used a randomized crossover design.100 patients who met the criteria were randomly assigned to the U3-1 group(first stage with Gla-300,second stage with Gla-100)or the U1-3 group(first stage with Gla-100,second stage with Gla-300).In the first stage,Gla-300 and Gla-100 were given as basal insulin therapy,and both groups of patients used insulin aspart as mealtime insulin therapy.Specialized nurses were responsible for daily insulin injections,monitoring and recording blood glucose levels using a blood glucose monitor(BGM),monitoring 4-point blood glucose(fasting blood glucose(FBG),2-hour postprandial blood glucose),and monitoring 8-point blood glucose using continuous glucose monitoring(CGM)(3am blood glucose,pre-meal,2-hour postprandial blood glucose,bedtime(9pm)blood glucose).The insulin dose was adjusted according to the patient’s blood glucose level.Gla-300 and Gla-100 were adjusted by 0.1U/kg per day until FBG reached the target(<7.8mmol/L),and the first stage ended.In the second stage,the original Gla-300 and Gla-100 were converted to an equimolar dose of another type of insulin,and insulin aspart was maintained at the dose at the end of the first stage without further adjustment,only adjusting the dose of the other insulin according to FBG.The plan was the same as before until FBG reached the target,and the second stage ended.Low blood sugar events were recorded at any time.Results:1.Comparison between groups:(1)In U3-1 group(n=39)was(3.9±1.5)days,and the ratio of time to reach the standard of FBG in U1-3 group(n=39)was(2.8±1.40)days.There was significant difference between the two groups(t=-3.384,P=0.001).(2)Comparison of the dose required to achieve FBG target:the basic insulin dose of U3-1 group(n=39)was(31.4±12.3)U,and U1-3 group(n=39)was(24.4±10.6)U.There was significant difference between the two groups(t=-2.685,P=0.009).2.Second stage(cross-over comparison):(1)In U3-1 group(n=31),there was no statistically significant difference in the required insulin dose to achieve the FBG target before and after the exchange(30.0±12.7 vs 30.4±12.0U,t=-0.695,P=0.515).In U1-3 group(n=30),there was a statistically significant difference in the required insulin dose before and after the exchange(23.9±10.4 vs 27.7±12.2U,t=-2.793,P=0.009).(2)Comparison of blood glucose levels when using two equimolar doses of insulin.In U3-1 group,there was a statistically significant decrease in FBG after switching from Gla-300 to Gla-100(7.1±0.5 vs 6.3±0.9 mmol/L,P<0.001),and the blood glucose control effect was similar at other times.In U1-3 group,there was a statistically significant increase in FBG after switching from Gla-100 to Gla-300(6.9±0.7 vs7.5±1.5 mmol/L,P=0.036),and the blood glucose control effect was similar at other times.(3)Comparison of blood glucose levels before and after the exchange when FBG reached the target.In U3-1 group,there was a statistically significant lower FBG level after switching from Gla-300 to Gla-100(P<0.001),and the blood glucose control effect was similar at other times.In U1-3 group,there was a similar FBG level after switching from Gla-100 to Gla-300,and the blood glucose control effect was similar at other times.3.Comparison of blood glucose variability before and after the exchange.When using two equimolar doses of insulin,there was no statistically significant difference in the daily blood glucose standard deviation before and after the exchange in both the U3-1 and U1-3 groups.When FBG reached the target,there was no statistically significant difference in the daily blood glucose standard deviation before and after the exchange in both the U3-1 and U1-3 groups.4.Hypoglycemic events:When using Gla-300 to control blood glucose(21:00-7:00),at least one hypoglycemic event occurred in 8 people,including one severe hypoglycemic event,with a hypoglycemic incidence rate of 11.6%.When using Gla-100 to control blood glucose(21:00-7:00),at least one hypoglycemic event occurred in10 people,with no severe hypoglycemic events,and a hypoglycemic incidence rate of14.3%.There was no statistically significant difference between the groups(χ~2=0.223,P=0.642).Conclusion:In hospitalized patients with type 2 diabetes,insulin glargine U300and insulin glargine U100 have similar efficacy and safety in blood glucose control,but U300 needs more time to get the same blood glucose control effect. |
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