title: Starting glargine in insulin-naïve type 2 diabetic patients based on body mass index is safe.
abstract: OBJECTIVE
  To evaluate the safety of four insulin titration algorithms in a homogeneous population of insulin-naïve type 2 diabetic patients.
  
  
  METHODS
  We conducted a 24-wk, open, single-center study with 92 insulin-naïve 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.
  
  
  CONCLUSIONS
  Starting insulin glargine based on BMI is safe, but fast titration algorithms increase the risk of moderate hypoglycemia.
authors.affiliation: Denise R Franco, Juliana Baptista, Fatima RM Abreu, Risoneide B Batista, Freddy G Eliaschewitz, Medical Department, Clinical Research Center (CPCLIN), São Paulo 01244-030, Brazil.
authors.forename: Denise R
authors.initials: DR
authors.lastname: Franco
authors.affiliation: Denise R Franco, Juliana Baptista, Fatima RM Abreu, Risoneide B Batista, Freddy G Eliaschewitz, Medical Department, Clinical Research Center (CPCLIN), São Paulo 01244-030, Brazil.
authors.forename: Juliana
authors.initials: J
authors.lastname: Baptista
authors.affiliation: Denise R Franco, Juliana Baptista, Fatima RM Abreu, Risoneide B Batista, Freddy G Eliaschewitz, Medical Department, Clinical Research Center (CPCLIN), São Paulo 01244-030, Brazil.
authors.forename: Fatima Rm
authors.initials: FR
authors.lastname: Abreu
authors.affiliation: Denise R Franco, Juliana Baptista, Fatima RM Abreu, Risoneide B Batista, Freddy G Eliaschewitz, Medical Department, Clinical Research Center (CPCLIN), São Paulo 01244-030, Brazil.
authors.forename: Risoneide B
authors.initials: RB
authors.lastname: Batista
authors.affiliation: Denise R Franco, Juliana Baptista, Fatima RM Abreu, Risoneide B Batista, Freddy G Eliaschewitz, Medical Department, Clinical Research Center (CPCLIN), São Paulo 01244-030, Brazil.
authors.forename: Freddy G
authors.initials: FG
authors.lastname: Eliaschewitz
keywords: Basal insulin; Hypoglycemia; Insulin glargine; Titration algorithms; Type 2 diabetes