This is a post hoc analysis of a multi-country study of adults with type 2 diabetes transitioned from basal-only to basal-bolus insulin therapy. Patients were randomized 1:1 to deliver mealtime insulin using either a wearable delivery device (PAQ Meal) or a pen (NovoLog FlexPen®). We report the proportion of patients overall who achieved A1C ≤8% and A1C ≤7% by Week 24 and sustained the improvement through Week 44 when using a basal-bolus regimen. Baseline A1C ranged from 7.0 - 11.8% (patients, n=274). By week 24, 84.7% (232/274) of patients achieved A1C ≤ 8% (LOCF) which continued at 84.8% (184/217 completers) at Week 44. Overall, 77.9% (169/217) of patients saw a reduction of at least 1% in A1C by Week 44. Although, patients with higher baselines achieved a greater reduction of A1C, patients with lower baselines were significantly more likely to achieve A1C ≤ 7%. Reduction in A1C ≤ 7% was sustained by 63.6% (138/217) of patients through Week 44. Initiating a basal-bolus regimen and titrating based on morning and mealtime blood glucose levels saw the mean total daily dose increase from 47IU (basal only) at study entry to 121IU (basal-bolus) at Week 24 (0.8:1 basal:bolus). Only 6 severe hypoglycemic events occurred during the study. This study shows that transitioning from basal insulin-alone to basal-bolus insulin therapy, regardless of delivery mechanism, safely reduces and manages A1C levels in T2DM patients.
R. Barry: Consultant; Self; CeQur Corporation. D. Johns: Consultant; Self; CeQur Corporation. B. Rees: None.
