AIM:To evaluate the safety of four insulin titration algorithms in a homogeneous population of insulin-na ve type 2 diabetic patients.METHODS:We conducted a 24-wk,open,single-center study with 92 insulin-na ve type 2 diabetes patients who failed treatment with one or two oral drugs.The patients were randomized to one of the four following algorithms:LANMET(n=26)and LANMET PLUS(n=22)algorithms,whose patients received a fixed initial insulin dose of 10 U,and DeGold(n=23)and DeGold PLUS(n=21)algorithms,whose patients’initial insulin dose was based on their body mass index(BMI).In addition,patients in the PLUS groups had their insulin titrated twice a week from 2 to 8 U.In the other two groups,the titration was also performed also twice a week,but in a fixed increments of 2 U.The target fasting glucose levels for both groups was 100 mg/dL.RESULTS:There was no significant difference in efficacy parameters.There was no significant difference when comparing moderate hypoglycemia events in algorithms starting with a 10 U fixed dose and algorithms based on BMI.However,there was a significant increase in moderate hypoglycemia events among the PLUS treated patients when the LANMET and DeGold algorithms were compared with the 2 fast-titration PLUS algorithms.We observed 12 hypoglycemia events in the first group,which corresponded to 0.94 events/patient per year,and we observed 42 events in the second group,which corresponded to 2.81 events/patient per year(P<0.037).No further significant differences were observed when other comparisons between the algorithms were carried out.CONCLUSION:Starting insulin glargine based on BMI is safe,but fast titration algorithms increase the risk of moderate hypoglycemia.
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