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Abstract: TH-OR033

CKD Outcomes in Type 2 Diabetes and Moderate-to-Severe CKD Treated with Dulaglutide Versus Insulin Glargine: AWARD-7

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Tuttle, Katherine R., University of Washington School of Medicine, Spokane, Washington, United States
  • Lakshmanan, Mark, Eli Lilly and Company, Indianapolis, Indiana, United States
  • Rayner, Brian, Division of Nephrology and Hypertension, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa
  • Zimmermann, Alan G., Formerly at Eli Lilly and Company, Indianapolis, Indiana, United States
  • Woodward, Brad, Eli Lilly and Company, Indianapolis, Indiana, United States
  • Botros, Fady T., Eli Lilly and Company, Indianapolis, Indiana, United States
Background

In the Assessment of Weekly AdministRation of Dulaglutide in Diabetes-7 (AWARD-7) study, dulaglutide (DU) treatment was associated with slower decline in estimated glomerular filtration rate (eGFR) compared to insulin glargine (IG) in participants with type 2 diabetes (T2D) and moderate-to-severe chronic kidney disease (CKD). The present analysis is aimed to determine CKD outcomes by treatment group.

Methods

As treatment for T2D, participants with T2D and CKD stages 3-4 were randomized (1:1:1) to receive DU 0.75 mg, DU 1.5 mg, or titrated IG, all added-on to titrated insulin lispro, for 1 year in this open-label (DU dose-blinded), phase 3 clinical study. In this prespecified exploratory analyses, proportions of participants experiencing ≥40% eGFR decline, end-stage renal disease (ESRD), or kidney disease-related death were compared between groups as composite and individual outcomes. For the composite outcome, a time-to-event analysis was conducted using a Cox proportional hazards model.

Results

The age (mean ± SD) of participants was 64.5 ± 8.5 years and 264/549 (48%) were women. At baseline, diabetes duration (mean ± SD) was 18.1 ± 8.8 years, HbA1c was 8.6 ± 1.0%, eGFR was 38 ± 13 mL/min/1.73 m2, and median (interquartile range) urine albumin-creatinine ratio was 209 (39, 965) mg/g. HbA1c declined similarly in all groups by a mean of approximately 1% over 1 year. The composite outcome was experienced by 47/576 (8.2%) participants: 10/192 (5.2%) in DU 1.5 mg, 16/190 (8.4%) in DU 0.75 mg, and 21/194 (10.8%) in IG (p=0.046, p=0.548 versus IG, respectively).The time-to-event for the composite outcome was significantly better for DU 1.5 mg versus IG (Cox model; p=0.038). Proportions with eGFR decline ≥40% occurred in: 2/192 (1.0%) in DU 1.5 mg, 7/190 (3.7%) in DU 0.75 mg, and 6/194 (3.1%) in IG. Proportions reaching ESRD were: 8/187 (4.3%) in DU 1.5 mg, 14/184 (7.6%) in DU 0.75 mg, and 16/191 (8.4%) in IG. Between-group comparisons were not significant for individual outcomes. No kidney disease-related deaths were reported.

Conclusion

One-year treatment with DU 1.5 mg was associated with a lower rate of CKD outcomes, including the composite outcome of eGFR decline ≥40% or ESRD, compared to IG at similar levels of glycemic control.

Funding

  • Commercial Support