Dosing of Insulin Glargine to Achieve the Treatment Target in Japanese Type 2 Diabetes on a Basal Supported Oral Therapy Regimen in Real Life: ALOHA Study Subanalysis

Diabetes Technol Ther. 2012 Jul;14(7):635-43. doi: 10.1089/dia.2011.0220. Epub 2012 Apr 23.


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.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Asian Continental Ancestry Group*
  • Blood Glucose / metabolism*
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / ethnology
  • Dose-Response Relationship, Drug
  • Female
  • Follow-Up Studies
  • Glycated Hemoglobin A / metabolism*
  • Humans
  • Hypoglycemic Agents / administration & dosage*
  • Hypoglycemic Agents / pharmacology
  • Insulin Glargine
  • Insulin, Long-Acting / administration & dosage*
  • Insulin, Long-Acting / pharmacology
  • Male
  • Middle Aged
  • Patient Compliance
  • Prospective Studies


  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Insulin, Long-Acting
  • hemoglobin A1c protein, human
  • Insulin Glargine