Efficacy and safety assessment of basal supported oral therapy (BOT) with insulin glargine in a real-life clinical setting, stratified by concomitant orally administered antidiabetic agent (OAD) regimens including dipeptidyl peptidase-4 inhibitor (DPP-4i): subanalysis of the ALOHA2 study, drug-use surveillance in Japan.

Aims And Introduction: We aimed to explore concomitant orally administered antidiabetic agent (OAD) regimens used in basal supported oral therapy (BOT) with insulin glargine in a real-life setting, and to assess the efficacy and safety of each regimen using data from the Add-on Lantus to Oral Hypoglycemic Agents 2 study, a 24-week observational study in Japanese type 2 diabetes patients.

Materials And Methods: Among 1629 insulin-naïve patients who had a glycosylated hemoglobin (HbA1c) value of ≥6.5 % during the previous 4 weeks and were treated with BOT during the observational period, 1227 patients who retained the same concomitant OAD regimens throughout the period were included in the analysis.

Results: Sulfonylurea (71.5 %), dipeptidyl peptidase-4 inhibitor (DPP-4i; 60.7 %), and biguanide (BG; 48.6 %) were commonly administered OADs in BOT. The HbA1c level decreased in patients taking BG alone (-2.76 %) and DPP-4i alone (-2.46 %). Of the three OADs, mean doses of the most frequently administered OAD changed from baseline to the final evaluation point: 2.5-2.3 mg for glimepiride, 59.1-58.7 mg for sitagliptin, and 1145.6-1168.2 mg for metformin. No significant difference in the hypoglycemia incidence rate was found between regimens ( = 0.3765), with incidence rates of 1.9 % (DPP-4i alone) to 7.0 % (other regimens) observed.

Conclusions: DPP-4i plays a major role in BOT with insulin glargine in a real-life setting. The incidence of hypoglycemia did not differ significantly between BOT regimens, including DPP-4i. Insulin glargine added to DPP-4i is a potential therapeutic approach.