Effects of switching from prandial premixed insulin therapy to basal plus two times bolus insulin therapy on glycemic control and quality of life in patients with type 2 diabetes mellitus

Background: The effects of switching from prandial premixed insulin therapy (PPT) injected three times a day to basal plus two times bolus insulin therapy (B2B) on glycemic control and quality of life were investigated in patients with type 2 diabetes mellitus. Methods: The clinical course was prospectively observed during the first 16 weeks after switching to B2B (insulin glargine plus insulin glulisine before breakfast and dinner) in 27 subjects previously treated with PPT using 50/50 premixed insulin. The Diabetes Treatment Satisfaction Questionnaire (DTSQ) was administered at the start and end of the study. Results: The glycated hemoglobin (HbA(1c)) level (8.3%+/- 1.8% to 8.2%+/- 1.1%) and the DTSQ score did not change between the start and end of the study. An improvement in HbA(1c) level was found in nine (33%) subjects. The change in HbA(1c) showed a significant negative correlation with baseline HbA1c, and was significantly better in patients with a baseline HbA(1c)>8.0% than in those with an HbA(1c) <= 8.0% (-0.9 +/- 2.0 versus 0.3 +/- 0.6, respectively, P=0.02). The change in DTSQ score representing treatment satisfaction was significantly greater in patients whose HbA(1c) level was improved than in those in whom it was not (2.7 +/- 3.6 versus -0.8 +/- 3.5, P=0.04). Conclusion: B2B was noninferior to PPT with regard to HbA1c levels in patients with type 2 diabetes mellitus. B2B should be considered particularly for subjects whose glycemic control is poor despite PPT.