AIM/INTRODUCTION: Subsample analysis was performed to examine whether dose optimization of insulin glargine (Lantus(®); Sanofi-Aventis K.K., Tokyo, Japan) contributed to achieving a target glycosylated hemoglobin (HbA1c) (<7.0%) by using the data from the Add-on Lantus to Oral Hypoglycemic Agents (ALOHA) study, a 24-week observational study of Japanese type 2 diabetes patients. We investigated the conditions of optimal dose titration by identifying patient background of dose-achiever and non-achiever subgroups.
Subjects and methods: The insulin-naive patients (n=3,180) were categorized into four groups depending on their HbA1c and insulin glargine dose at 24 weeks: patients with HbA1c <7.0% and dose <8.5 U/day (Group 1), HbA1c <7.0% and dose ≥8.5 U/day (Group 2), HbA1c ≥7.0% and dose <8.5 U/day (Group 3), and HbA1c ≥7.0% and dose ≥8.5 U/day (Group 4).
Results: The greatest reduction in HbA1c was observed in Group 2 (-2.7%, P<0.001 vs. Group 3 or 4). Fasting plasma glucose (FPG) in Group 2 at 24 weeks (113.3 mg/dL) was significantly lower than in either Group 3 or 4 (135.4 mg/dL and 150.0 mg/dL, respectively; P<0.001 for both). The starting dose and the change of insulin glargine dose were significantly greater in Group 2 than in Group 3 (0.142 vs. 0.086 U/kg/day [P<0.001] and +5.0 vs. +1.1 U/day [P<0.001], respectively), whereas the baseline HbA1c levels and body mass index were comparable (9.3% vs. 9.4% and 23.5 kg/m(2) vs. 23.3 kg/m(2), respectively).
Conclusions: Our results suggest that appropriate starting dosage and subsequent dose adjustment are essential to achieve target HbA1c (<7%) and that the FPG level should be decreased to be 110 mg/dL or below for this achievement.