Efficacy and Safety of Dulaglutide in Type 2 Diabetes and Chronic Kidney Disease

June 14, 2018. AWARD-7, a multicenter, 52-week, open-label, randomized trial compared the efficacy and safety of the glucagon-like peptide-1 receptor agonist dulaglutide (1.5 mg and 0.75 mg) vs insulin glargine, both in combination with insulin lispro. Patients (N=577) had type 2 diabetes and moderate-to-severe chronic kidney disease. At 26 weeks, the effects of dulaglutide 1.5 mg and 0.75 mg on A1C levels were non-inferior to glargine: least squares mean (LSM) -1.2% (standard error [SE] 0.1); -1.1% (0.1); and -1.1% (0.1), respectively; 1-sided P≤0.0001 for both dulaglutide doses vs glargine. The LSM differences between dulaglutide and insulin glargine in A1C at 26 weeks were -0.05% (95% confidence interval [CI] -0.26 to 0.15, P<0.0001) with dulaglutide 1.5 mg and 0.02% (95% CI: -0.18 to -0.22; P=0.0001) with dulaglutide 0.75 mg. This A1C-lowering effect persisted to 52 weeks, at which time estimated glomerular filtration rate was higher with dulaglutide 1.5 mg (LSM 34.0 mL/min per 1.73 m2 [SE 0.7]; P=0.005 vs glargine) and dulaglutide 0.75 mg (33.8 mL/min per 1.73 m2 [SE 0.7]; P=0.009 vs glargine) than with glargine (31.3 mL/min per 1.73 m2 [SE 0.7]). There were no significant between-group differences for reductions in urinary albumin-to-creatinine ratio. Across all groups, a similar proportion of patients experienced a serious adverse event. Dulaglutide was associated with higher rates of nausea and diarrhea and lower rates of symptomatic hypoglycemia. End-stage renal disease occurred in 8 (4%), 14 (7%), and 16 (8%) patients in the dulaglutide 1.5 mg, 0.75 mg, and glargine groups, respectively. Follow this link to read the study abstract.