Effects of once‐weekly dulaglutide on kidney function in patients with type 2 diabetes in phase II and III clinical trials

• Published in: Diabetes, obesity & metabolism obesity & metabolism, 2017-03, Vol.19 (3), p.436-441
• Main Authors: Tuttle, Katherine R., McKinney, T. Dwight, Davidson, Jaime A., Anglin, Greg, Harper, Kristine D., Botros, Fady T.
• Format: Article
• Language: English
• Subjects: Acute Kidney Injury - chemically induced; Acute Kidney Injury - metabolism; Aged; Albuminuria; Brief Report; Brief Reports; clinical trial; Clinical trials; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Creatinine - urine; Diabetes; diabetes complications; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - metabolism; diabetic nephropathy; dulaglutide; Female; Glomerular Filtration Rate; GLP-1 receptor agonists; GLP‐1; Glucagon-Like Peptide-1 Receptor - agonists; Glucagon-Like Peptides - analogs & derivatives; Glucagon-Like Peptides - therapeutic use; Humans; Hypoglycemic Agents - therapeutic use; Immunoglobulin Fc Fragments - therapeutic use; Insulin; Insulin Glargine - therapeutic use; Kidney Function Tests; Male; Middle Aged; Recombinant Fusion Proteins - therapeutic use; Treatment Outcome; type 2 diabetes
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.12816

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.