Weight loss with once-weekly dulaglutide versus insulin glargine, both with insulin lispro (+/- metformin), in patients with type 2 diabetes (T2D) from AWARD-4, stratified by baseline body mass index (BMI) category

Objective: For T2D patients with increased BMI ≥27 kg/m² or > 35 kg/m², German national guidelines recommend weight loss of ˜5% or > 10%, respectively. Bodyweight data from the open-label AWARD-4 trial comparing once-weekly dulaglutide 1.5 mg vs. glargine, both with lispro ± metformin, were analysed post hoc by baseline BMI category.

Methods: Proportions of patients were described and compared for dulaglutide 1.5 mg (N = 295) vs. glargine (N = 296) across baseline BMI categories (≥27-< 35/≥35 kg/m²) for weight loss ≥3%, ≥5% or ≥10% and the composite endpoint (HbA1c < 7% and weight loss ≥3%) after 52 weeks.

Results: At baseline, mean BMI was 32.0 kg/m² (dulaglutide) and 32.4 kg/m² (glargine). Least squares mean (SE) weight change was -0.35 (0.34)kg with dulaglutide and

+2.89 (0.33)kg with glargine (p < 0.001). Weight loss ≥3%, ≥5% or ≥10% was achieved by 22.4% vs. 5.8% (p < 0.001), 10.8% vs. 2.4% (p < 0.001) and 1.8% vs. 0.0% (p = 0.029) of dulaglutide- vs. glargine-treated patients, respectively. Of 172 dulaglutide- vs. 161 glargine-treated patients with baseline BMI ≥27-< 35 kg/m², 20.9% vs. 3.7%, 9.3% vs. 2.5% and 1.2% vs. 0.0% achieved weight loss ≥3%, ≥5% or ≥10%, respectively. Respective proportions of 72 dulaglutide- and 88 glargine-treated patients with baseline BMI ≥35 kg/m² were 15.3% vs. 10.2%, 11.1% vs. 3.4% and 4.2% vs. 0.0%. Overall, 14.2% of dulaglutide-treated and 2.5% of glargine-treated patients achieved the composite endpoint (p < 0.001).

Conclusions: Across these BMI categories, more patients receiving once-weekly dulaglutide 1.5 mg than glargine achieved a glycaemic efficacy target combined with favourable weight change. Mean weight reduction and proportions of patients with weight loss above different thresholds were greater with dulaglutide.