Effects of once weekly dulaglutide 1.5 mg on glycaemic control, weight and hypoglycaemia in patients with Type 2 diabetes in the AWARD-1 and AWARD-2 clinical trials

Research Question: To evaluate the effects of once weekly dulaglutide 1.5 mg versus insulin glargine or exenatide BID on HbA1c, weight and hypoglycaemia in the AWARD-1 and AWARD-2 clinical trials with patients with baseline HbA1c ≥7.5%. Methodology: AWARD-1 was a 52-week, multicentre, parallel-arm study; patients on metformin and pioglitazone were randomised to once-weekly dulaglutide 1.5 mg, dulaglutide 0.75 mg, exenatide BID, or placebo (26 week only). AWARD-2 was a 78-week study; patients on metformin and glimepiride were randomised to once-weekly dulaglutide 1.5 mg, dulaglutide 0.75 mg, or daily insulin glargine. In this post-hoc analysis the primary measurement was a composite endpoint including proportion of patients achieving HbA1c < 7.5%, without weight gain and without hypoglycaemia. Data were analysed at 26 weeks of treatment on patients from the Intent to Treat population with baseline HbA1c ≥7.5%. Comparisons between dulaglutide 1.5 mg and exenatide BID or insulin glargine were conducted for each study separately. Findings: In both AWARD-1 (dulaglutide 1.5 mg, n = 162; exenatide BID, n = 153) and AWARD-2 (dulaglutide 1.5 mg, n = 189; insulin glargine, n = 175), a greater proportion of patients achieved the composite endpoint with dulaglutide 1.5 mg than with the comparator (AWARD-1: dulaglutide 1.5 mg, 50.0% [95% CI, 42.3 – 57.7%]; exenatide BID, 28.1% [21.0 – 35.2%]; AWARD-2: dulaglutide 1.5 mg, 49.2% [95% CI, 42.1 – 56.3%]; insulin glargine, 9.1% [4.9 – 13.4%]). Conclusion: Treatment with once-weekly dulaglutide 1.5 mg on background of two oral antidiabetic medications in patients with HbA1c ≥7.5% resulted in a greater proportion of patients achieving HbA1c < 7.5% without weight gain and without hypoglycaemia compared with exenatide BID or insulin glargine.