Abstract: FR-OR088

Dulaglutide Treatment Is Associated with Less eGFR Decline and Greater Reduction in Albuminuria in Type 2 Diabetes and CKD Stages 3-4 (AWARD-7)

Session Information

Category: Diabetes

  • 502 Diabetes Mellitus and Obesity: Clinical

Authors

  • Tuttle, Katherine R., Providence Health Care, University of Washington School of Medicine, Spokane, Washington, United States
  • Lakshmanan, Mark C., Eli Lilly and Company, Indianapolis, Indiana, United States
  • Gross, Jorge L., Centro de Pesquisas em Diabetes, Porto Alegre, Rio Grande do Sul, Brazil
  • Rayner, Brian, Division of Nephrology and Hypertension, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa
  • Busch, Robert S., Albany Medical Center Division of Community Endocrinology, Albany, New York, United States
  • Woodward, Brad, Eli Lilly and Company, Indianapolis, Indiana, United States
  • Zimmermann, Alan G., Eli Lilly and Company, Indianapolis, Indiana, United States
  • Botros, Fady T., Eli Lilly and Company, Indianapolis, Indiana, United States
Background

The AWARD-7 phase 3 trial compared weekly dulaglutide (DU 1.5 or 0.75 mg) to daily insulin glargine (IG), both with insulin lispro, in participants with type 2 diabetes (T2D) and chronic kidney disease (CKD) stages 3-4.

Methods

Baseline (BL) characteristics (N=576) were: estimated glomerular filtration rate (eGFR CKD-EPI): 38±13 mL/min/1.73m2 [mean±SD], urine albumin/creatinine ratio (UACR, mean [median]): 847.2 (209.3), age: 65±9 years, A1c: 8.6±1.0%, duration of T2D: 18±9 years.

Results

After 52 weeks, mean eGFR was not statistically different from BL with DU 1.5 mg, while it decreased with DU 0.75 mg and IG; UACR decreased from BL with both DU doses (table). DU 1.5 mg vs IG differences were statistically significant in participants with UACR >300 mg/g. Both doses of DU were noninferior to IG for the change in A1c.

Conclusion

In participants with T2D and CKD stages 3-4, overall effects on eGFR and UACR were mainly driven by lesser eGFR decline and greater UACR reduction in the DU 1.5 mg group vs IG in participants with UACR >300 mg/g.

Table. Effects of DU and IG on eGFR and albuminuria after 52 weeks
Study GroupAll (N=576)UACR >300 mg/g (n=258)UACR ≤300 mg/g (n=317)
Δ eGFR, mL/min/1.73m2%Δ UACRΔ eGFR, mL/min/1.73m2%Δ UACRΔ eGFR, mL/min/1.73m2%Δ UACR
DU 1.5 mg (N=192)-1.1
(-2.4, 0.2)
-22.5*
(-35.1, -7.5)
-3.4**#
(-5.4, -1.4)
-29.0*#
(-43.0, -11.5)
-0.4
(-2.0, 1.3)
-3.4
(-24.0, 22.8)
DU 0.75 mg (N=190)-1.5*
(-2.8, -0.2)
-20.1*
(-33.1, -4.6)
-5.2**
(-7.1, -3.2)
-12.3
(-29.0, 8.5)
0.2
(-1.4, 1.9)
-15.3
(-33.6, 8.0)
IG (N=194)-2.9**
(-4.2, -1.6)
-13.0
(-27.1, 3.9)
-6.3**
(-8.2, -4.4)
0.1
(-18.8, 23.4)
-1.3
(-2.9, 0.4)
-9.9
(-29.0, 14.4)

Data are change from BL least squares mean (95% confidence interval). *2-sided p<0.05 and **2-sided p<0.001 change from BL, #2-sided p<0.05 and ##2-sided p<0.001 vs IG

Funding

  • Commercial Support