Efficacy and Safety of Dulaglutide 3.0 mg and 4.5 mg Versus Dulaglutide 1.5 mg in Metformin-Treated Patients With Type 2 Diabetes in a Randomized Controlled Trial (AWARD-11)

OBJECTIVE To compare efficacy and safety of dulaglutide at doses 3.0 4.5 mg versus 1.5 in patients with type 2 diabetes inadequately controlled metformin. RESEARCH DESIGN AND METHODS Patients were randomly assigned to once-weekly mg, or for 52 weeks. The primary objective was determining superiority and/or over HbA1c reduction 36 Secondary objectives included change body weight. Two estimands addressed objectives: treatment regimen (regardless discontinuation rescue medication) (on without all patients. RESULTS Mean baseline BMI (N = 1,842) 8.6% (70 mmol/mol) 34.2 kg/m2, respectively. At weeks, provided superior reductions compared (treatment-regimen estimand: −1.77 vs. −1.54% [−19.4 −16.8 mmol/mol], estimated difference [ETD] −0.24% (−2.6 mmol/mol), P < 0.001; −1.87 −1.53% [−20.4 −16.7 ETD −0.34% (−3.7 0.001). Dulaglutide reducing HbA1c, using the estimand (ETD −0.17% [−1.9 mmol/mol]; 0.003) but not treatment-regimen −0.10% [−1.1 0.096). weight loss weeks both (treatment regimen: −4.6 −3.0 kg, −1.6 efficacy: −4.7 −3.1 Common adverse events through nausea (1.5 13.4%; 3 15.6%; 16.4%) vomiting 5.6%; 8.3%; 9.3%). CONCLUSIONS In by metformin, escalation from clinically relevant, dose-related a similar profile.