Glycemic control and adverse effects in patients with type 2 diabetes receiving basal-bolus insulin regimen versus premixed insulin regimen: An observational study

Several studies have compared the basal-bolus (BB) and premixed (PM) insulin regimens with varying results. This study aimed to evaluate the glycemic control and occurrence of hypoglycemia with these regimens in insulin-naïve patients with type 2 diabetes mellitus (T2D) in the Indian subpopulation. This was a 12-week (wk) prospective, observational study in 60 adult patients (distributed 1:1) with >7 years of T2D and uncontrolled with three oral drugs. Changes in glycemic parameters at wk4 and wk12 were assessed, and hypoglycemia events were also recorded. The PM insulin showed a significant decrease in fasting plasma glucose (FPG) at wk4 from baseline (P = 0.02) and at wk12 (P < 0.001), while in the BB insulin group, the change was significant only at wk12 (P < 0.0001). There were greater reductions in the PM group in FPG at wk4 (PM vs. BB: P = 0.04) and wk12 (P = 0.03) compared to the BB group. The post-prandial plasma glucose in both groups significantly reduced from baseline at wk4 (PM group P = 0.034; BB group; P = 0.034) and wk12 (PM group P < 0.0001 and BB group: P < 0.0001). However, there were no between-group differences at wk4 (P = 0.12) but only at wk12 (P = 0.009) with greater reductions in the PM group. The PM group showed a slightly greater reduction in glycated hemoglobin versus the BB group (9.18% vs. 7.08%; P = 0.39). There was no significant difference (P = 0.49) in the incidence of hypoglycemia. Both treatments significantly improved glycemic control and were not associated with any severe episodes of hypoglycemia. Therefore, the choice should instead be guided by the insulin-related (posology, complexity) and patient-related (dietary habits, adherence levels) factors.