Efficacy and Safety of Patient-Led Dosage Adjustments of Insulin Glargine: A Preliminary Report of Basal-Supported Oral Therapy for Japanese Type 2 Diabetes Patients

To evaluate the clinical utility for simple patient administered dose adjustment methods of insulin glargine during outpatient visits compared with a physician managed titration, changes in HbA1c and total daily dose of insulin were evaluated in 23 patients by dividing patients into physician-led (PL) group and self-titration (ST) group who were newly administered glargine basal-supported oral therapy (BOT) while continuing oral antidiabetic drugs at the discretion of their attending physician during regular outpatient visits. In the PL group, one month after initiation of glargine, HbA1c followed a declining trend, although this was not significant (P = 0.07), and decreased significantly after two and three months (P < 0.05, respectively). However, after 12 months, the significant difference had disappeared. By contrast, in the ST group, HbA1c did not significantly decrease one month after initiation of glargine, but did drop markedly after two and three months, with this trend continuing up to 12 months (P < 0.005). On examining the differences between both groups, we found that the initial dose was significantly larger in the PL group (P < 0.05), whereas the dose increased significantly more in the ST group after three months. While the insulin dose after 12 months was large in the ST group, no statistically significant difference was noted between the two groups (P = 0.14) whereas HbA1c was significantly low in the ST group. In conclusion, we believe that patient-led basal insulin dosage adjustment is an effective and useful therapeutic option when they can master self-monitoring of blood glucose.