Baseline characteristics related to disease severity can be predictors of a treatment’s HbA1c-lowering effect. The impact of baseline BMI and HbA1c on the efficacy and safety of mealtime fast-acting insulin aspart (faster aspart) in type 2 diabetes (T2D) was assessed in a post hoc analysis of two randomized phase 3a trials: a 26-week, double-blind, treat-to-target trial with mealtime insulin aspart (IAsp) in a basal-bolus regimen as comparator (onset 2), and an 18-week, open-label trial with basal insulin alone as comparator (onset 3). All individuals were taking metformin.
Estimated treatment difference (95% CI) for change in HbA1c in each trial was similar for all BMI and HbA1c subgroups with faster aspart vs. IAsp. Change in HbA1c according to baseline BMI <25, 25-<30 and >=30 kg/m2 was -0.21 (-0.61;0.19), 0.01 (-0.21;0.23) and -0.01 (-0.17;0.16), respectively, in onset 2; and -0.85 (-1.55;-0.15), -0.67 (-1.06;-0.28) and -1.12 (-1.43;-0.81) in onset 3. Change in HbA1c according to baseline HbA1c <=7.5, >7.5-<8.0 and >=8.0% was -0.07 (-0.28;0.15), 0.13 (-0.14;0.40) and -0.06 (-0.24;0.12) in onset 2; and -0.77 (-1.18;-0.37), -1.07 (-1.54;-0.61) and -1.03 (-1.37;-0.69) in onset 3.
No major differences between treatments were observed in risk of hypoglycemia or insulin dose across subgroups in either trial.
Neither baseline HbA1c nor BMI altered the glycemic response to faster aspart in individuals with T2D.