Brief Article
Copyright ©2014 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Diabetes. Feb 15, 2014; 5(1): 69-75
Published online Feb 15, 2014. doi: 10.4239/wjd.v5.i1.69
Starting glargine in insulin-naïve type 2 diabetic patients based on body mass index is safe
Denise R Franco, Juliana Baptista, Fatima RM Abreu, Risoneide B Batista, Freddy G Eliaschewitz
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
Denise R Franco, Associação do Diabetes Brazil (ADJ), São Paulo 05003-010, Brazil
Freddy G Eliaschewitz, Hospital Israelita Albert Einstein, São Paulo 05652-000, Brazil
Author contributions: Franco DR designed research, performed research, analyzed data and wrote the paper; Baptista J collected the data; Abreu FRM performed research; Batista RB performed research; Eliaschewitz FG designed research, performed research, analyzed data and wrote the paper.
Supported by Sanofi-Aventis Brazil
Correspondence to: Denise R Franco, MD, Medical Department, Clinical Research Center (CPCLIN), Rua Goias 193, São Paulo 01244-030, Brazil.
Telephone: +55-119-82694700 Fax: +55-112-7110298
Received: August 5, 2013
Revised: October 21, 2013
Accepted: January 15, 2014
Published online: February 15, 2014

AIM: 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.

CONCLUSION: Starting insulin glargine based on BMI is safe, but fast titration algorithms increase the risk of moderate hypoglycemia.

Keywords: Type 2 diabetes, Insulin glargine, Basal insulin, Hypoglycemia, Titration algorithms

Core tip: To start insulin therapy in insulin naïve type 2 diabetes patients, a long-acting basal insulin, such as insulin glargine, is added once a day. The majority of algorithms determine insulin titration according to fasting plasma glucose levels, but the dosage differs at the initial dose, frequency and speed of adjustments. It is difficult to compare the different algorithms employed in trials with populations of different socio-economic strata and variable access to educational materials. Here, we compared the safety of different titration algorithms in a population that was homogeneous in terms of socio-economic strata and with the same degree of education in diabetes.