357-OR: Efficacy and Safety of Dulaglutide 3mg and 4.5mg vs. Dulaglutide 1.5mg: 52-Week Results from AWARD-11

Abstract

Dulaglutide (DU) is approved at 2 doses (0.75 and 1.5 mg) for treatment of T2D. In this phase 3 study, once weekly DU 3 mg and 4.5 mg were compared to DU 1.5 mg for efficacy and safety through 52 weeks (wks) (primary endpoint at 36 wks) in patients with inadequately controlled T2D on metformin therapy. Patients were randomized (1:1:1) to once weekly DU 1.5 mg (n=612), DU 3 mg (n=616), and DU 4.5 mg (n=614). All patients were initiated on once weekly DU 0.75 mg for 4 wks, followed by step-wise dose escalation every 4 wks to the randomized dose of 1.5 mg, 3 mg, or 4.5 mg. Efficacy measures were analyzed based on data on-treatment without initiation of rescue medication. Mean age was 57.1 yrs, mean baseline (BL) A1C was 8.6%, and mean BL body weight (BW) was 95.7 kg. DU 1.5 mg, 3 mg and 4.5 mg showed significance (p<0.001) compared to BL for A1C, BW and fasting serum glucose (Table). DU 3 mg and 4.5 mg were both superior to DU 1.5 mg at the 36 wk primary endpoint, and remained significantly greater at 52 wks, for improvements in measures of glycemic control and body weight (Table). As expected for the GLP-1 receptor agonist class, commonly reported adverse events were nausea, diarrhea, and vomiting (Table). There were no new safety findings with the higher DU doses. In conclusion, escalation from DU 1.5 mg to DU 3 mg or 4.5 mg provided clinically relevant, dose-related improvements in glycemic control and body weight with an acceptable safety profile. Disclosure J.P. Frias: Consultant; Self; Eli Lilly and Company, Gilead Sciences, Inc., LifeScan, Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; Allergan plc., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb, Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S, Pfizer Inc., Sanofi. Speaker’s Bureau; Self; Merck & Co., Inc., Sanofi. E. Bonora: Advisory Panel; Self; Lilly Diabetes, Novartis AG, Sanofi. Speaker’s Bureau; Self; Abbott, Lilly Diabetes, Novo Nordisk A/S, Sanofi. L.A. Nevarez Ruiz: None. G. Li: Employee; Self; Eli Lilly and Company. Z. Yu: None. Z. Milicevic: Employee; Self; Eli Lilly and Company. R. Malik: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. A. Bethel: Employee; Self; Eli Lilly and Company. D. Cox: Employee; Self; Eli Lilly and Company.