Efficacy and safety of dulaglutide in the treatment of type 2 diabetes: a comprehensive review of the dulaglutide clinical data focusing on the AWARD phase 3 clinical trial program

Dulaglutide 1.5 mg was superior to active comparators in five out of six Phase 3 studies for achieving glycated hemoglobin A1c (HbA1c) targets of <7.0% (53.0 mmol/mol).

• In five of the six AWARD studies, dulaglutide 1.5 mg led to a greater proportion of patients reaching HbA1c targets compared to active comparators.
• Dulaglutide 1.5 mg was non-inferior to liraglutide in the AWARD-6 study.
• Dulaglutide 0.75 mg was superior to active comparators in four of five studies and non-inferior to insulin glargine in AWARD-2.
• Treatment with dulaglutide was associated with weight loss or reduced weight gain and low rates of hypoglycemia when used alone or with other non-insulin medications.
• Gastrointestinal side effects, including nausea, vomiting, and diarrhea, were the most commonly reported adverse events.
• The incidence of dulaglutide antidrug antibody formation was noted to be between 1-2.8%, with rare occurrences of injection site reactions.

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