Higher doses of dulaglutide induce weight loss in patients with type 2 diabetes (T2D) regardless of baseline BMI: post hoc analysis of AWARD-11

Background The AWARD-11 trial demonstrated that dulaglutide 3 mg and 4.5 mg once weekly improved glycated hemoglobin (A1C) and bodyweight, compared to dulaglutide 1.5 mg once weekly, in patients with T2D inadequately controlled with metformin monotherapy. The aim of this post hoc analysis was to assess the effect of dulaglutide on bodyweight in clinically relevant baseline body mass index (BMI) categories as defined by clinical practice guidelines.

Methods Eligible patients had screening A1C 7.5–11% and BMI ≥ 25 kg/m2. Patients (N=1842) were randomized to dulaglutide 1.5 mg, 3 mg, or 4.5 mg. Total treatment period was 52-weeks with primary efficacy endpoint at 36-weeks. Baseline BMI (kg/m2) was categorized as overweight (<30), obesity Class I (30 -<35), Class II (35 -<40) or Class III (≥40). Mixed model for repeated measures was used within the BMI subgroups for assessing change in bodyweight.

Results At 36-weeks, mean absolute reduction in bodyweight within each dulaglutide dose group increased by baseline BMI category, whereas mean percentage weight loss was similar regardless of BMI category in dulaglutide 3 mg and 4.5 mg groups. Treatment-by-BMI subgroup interaction was not significant for either absolute change or% change in bodyweight (interaction p=0.905 and 0.473, respectively). The pattern of common adverse events was similar across BMI subgroups.

Conclusion Treatment with dulaglutide 3 mg and 4.5 mg induces weight loss across a range of clinically relevant BMI categories in patients with T2D.

Publication History

Article published online:
26 May 2022