Percentage of patients with type 2 diabetes and baseline HbA1c ≥7.5% treated with once weekly dulaglutide, or exenatide twice daily, achieving HbA1c decrease of ≥1% and weight loss of ≥3% at 26 weeks in the Assessment of Weekly AdministRation of dulaglutide in Diabetes (AWARD)-1 and -5 studies

Introduction: We estimated the percentage of patients with baseline HbA1c ≥7.5% achieving HbA1c reduction ≥1% and weight loss ≥3% [NICE continuity criteria for glucagon-like peptide-1 (GLP-1) receptor agonists] after 26 weeks treatment with dulaglutide or exenatide, combined with oral antidiabetes medications. Methods: Post-hoc analysis was performed on pooled and individual study populations from two randomised studies, AWARD-1 and -5 (dulaglutide) and AWARD-1 (exenatide). Numbers of patients with baseline HbA1c ≥7.5%, with data at baseline and 6 months, were 344 for dulaglutide 1.5 mg (158, AWARD-1 and 186, AWARD-5), 344 for dulaglutide 0.75 mg (145 and 199, respectively) and 141 for exenatide. Results: Mean baseline age, duration of diabetes, body mass index (BMI), and HbA1c were similar in AWARD-1 and -5. Overall, 38.1% of dulaglutide 1.5 mg, 27.3% of dulaglutide 0.75 mg and 22.0% of exenatide recipients achieved NICE continuity criterion at 6 months. HbA1c reduction ≥1% without weight loss ≥3% was achieved by 44.8%, 44.8% and 38.3% of dulaglutide 1.5 mg, dulaglutide 0.75 mg and exenatide recipients, respectively, and 7.0%, 7.0% and 5.7% of patients, respectively, achieved weight loss ≥3% without achieving target HbA1c decrease. Considerably more patients in both dulaglutide dose groups achieved the NICE continuity criterion in AWARD-5 (background metformin) than in AWARD-1 (background metformin and pioglitazone). Conclusions: Overall, fewer than half of the patients receiving GLP-1 receptor agonists in these studies achieved the NICE continuity criterion, mainly as a result of failure to achieve the weight target. Reassuringly, u003e 75% of dulaglutide, and u003e 60% of exenatide recipients achieved the NICE HbA1c target.