Efficacy and safety of once weekly dulaglutide and once daily insulin glargine treatment at 52 weeks in patients with type 2 diabetes (T2DM) in the Assessment of Weekly AdministRation of dulaglutide in Diabetes-2 (AWARD-2) study, stratified by duration of diabetes (< 5 years, ≥5 to < 10 years, ≥10 years)

Introduction: We determined the impact of duration of diabetes (DoD) on the efficacy and safety of dulaglutide and insulin glargine treatment in patients with T2DM. Methods: Post hoc subgroup efficacy and safety analyses at 52 weeks were performed by baseline DoD (< 5, ≥5-< 10, ≥10 years) for patients (N = 807; mean [standard deviation] disease duration, 9.1 (6.0) years) receiving dulaglutide 1.5 mg (N = 273), dulaglutide 0.75 mg (N = 272) or insulin glargine (N = 262), all combined with metformin and glimepiride. Results: Baseline patient characteristics were similar between treatment groups according to DoD. For each treatment arm (dulaglutide 1.5 mg, dulaglutide 0.75 mg and insulin glargine), LS mean (standard error) HbA1c changes from baseline were (MMRM): DoD < 5 years: –0.88 (0.14)%, –0.66 (0.14)%, –0.44 (0.14)%; ≥5-< 10 years: –1.07 (0.10)%, –0.73 (0.11)%, –0.58 (0.10)%; ≥10 years: –1.15 (0.10)%, –0.71 (0.09)%, –0.63 (0.10)%; changes were greater with dulaglutide 1.5 mg than insulin glargine (p < 0.01) in all DoD subgroups. Treatment-by-subgroup interaction analysis (ANCOVA) showed a treatment effect (p < 0.001) but no effect of DoD on HbA1c change from baseline. More dulaglutide 1.5 mg- than insulin glargine-treated patients achieved HbA1c < 7% (p < 0.05) in all DoD subgroups. Dulaglutide reduced, while insulin glargine increased bodyweight (p < 0.01, both dulaglutide doses vs. glargine) in all DoD subgroups. For each treatment arm (dulaglutide 1.5 mg, dulaglutide 0.75 mg and insulin glargine) total hypoglycaemia rates (events/patient/year) were: DoD < 5 years: 3.27, 4.59, 5.81; ≥5–< 10 years: 4.87, 3.59, 8.98; > 10 years: 6.68, 5.92, 7.99. Conclusions: In AWARD-2, irrespective of DoD, treatment with dulaglutide was effective in improving HbA1c and weight without increased risk of hypoglycaemia compared with insulin glargine.