title: Effects of once-weekly dulaglutide on kidney function in patients with type 2 diabetes in phase II and III clinical trials.
abstract: Dulaglutide is a once-weekly glucagon-like peptide-1 receptor agonist approved for the treatment of type 2 diabetes (T2D). Integrated data from 9 phase II and III trials in people with T2D (N = 6005) were used to evaluate the effects of dulaglutide on estimated glomerular filtration rate (eGFR [Chronic Kidney Disease Epidemiology Collaboration]), urine albumin-to-creatinine ratio (UACR) and kidney adverse events (AEs). No significant differences in eGFR were observed during treatment for dulaglutide vs placebo, active comparators or insulin glargine (mean ± standard deviation values: dulaglutide vs placebo: 87.8 ± 17.7 vs 88.2 ± 17.9 mL/min/1.73 m2, P = .075; dulaglutide vs active comparators: 89.9 ± 16.7 vs 88.8 ± 16.3 mL/min/1.73 m2, P = .223; and dulaglutide vs insulin glargine: 85.9 ± 18.2 vs 83.9 ± 18.6 mL/min/1.73 m2, P = .423). Lower UACR values were observed for dulaglutide vs placebo, active comparators and insulin glargine (at 26 weeks, median [Q1-Q3] values were: dulaglutide vs placebo: 8.0 [4.4-20.4] vs 8.0 [4.4-23.9] mg/g, P = .023; dulaglutide vs active comparators: 8.0 [4.4-21.2] vs 8.9 [4.4-27.4] mg/g, P = .013; and dulaglutide vs insulin glargine: 8.9 [4.4-29.2] vs 12.4 [5.3-50.5] mg/g, P = .029). AEs reflecting potential acute renal failure were 3.4, 1.7 and 7.0 events/1000 patient-years for dulaglutide, active comparators and placebo, respectively. In conclusion, dulaglutide treatment of clinical trial participants with T2D did not affect eGFR and slightly decreased albuminuria.
authors.affiliation: Providence Health Care, University of Washington, Spokane, Washington.
authors.forename: Katherine R
authors.initials: KR
authors.lastname: Tuttle
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: T Dwight
authors.initials: TD
authors.lastname: McKinney
authors.affiliation: Touchstone Diabetes Center, University of Texas Southwestern Medical Center, Dallas, Texas.
authors.forename: Jaime A
authors.initials: JA
authors.lastname: Davidson
authors.affiliation: Eli Lilly Canada, Toronto, Ontario, Canada.
authors.forename: Greg
authors.initials: G
authors.lastname: Anglin
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Kristine D
authors.initials: KD
authors.lastname: Harper
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Fady T
authors.initials: FT
authors.lastname: Botros
mesh_terms: D058186:Acute Kidney Injury / Q000139:chemically induced* / Q000378:metabolism; D000368:Aged; D000419:Albuminuria; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D003404:Creatinine / Q000652:urine; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D005260:Female; D005919:Glomerular Filtration Rate; D004763:Glucagon-Like Peptides / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007141:Immunoglobulin Fc Fragments / Q000627:therapeutic use*; D000069036:Insulin Glargine / Q000627:therapeutic use; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use*; D016896:Treatment Outcome; D000097789:Glucagon-Like Peptide-1 Receptor Agonists
chemical_list: D007004:Hypoglycemic Agents; D007141:Immunoglobulin Fc Fragments; D011993:Recombinant Fusion Proteins; D000069036:Insulin Glargine; D004763:Glucagon-Like Peptides; D003404:Creatinine; C555680:dulaglutide; D000097789:Glucagon-Like Peptide-1 Receptor Agonists
keywords: 
  GLP-1; clinical trial; diabetes complications; diabetic nephropathy; dulaglutide; type 2 diabetes