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Kidney Week

Abstract: SA-OR081

Clinical Events in Type 2 Diabetes and Moderate-to-Severe CKD by Albuminuria Status: Dulaglutide vs. Insulin Glargine

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
  • Rayner, Brian, Division of Nephrology and Hypertension, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa
  • Lakshmanan, Mark, Eli Lilly and Company, Indianapolis, Indiana, United States
  • Woodward, Brad, Eli Lilly and Company, Indianapolis, Indiana, United States
  • Kwan, Anita, Eli Lilly and Company, Indianapolis, Indiana, United States
  • Konig, Manige, Eli Lilly and Company, Indianapolis, Indiana, United States
  • Botros, Fady T., Eli Lilly and Company, Indianapolis, Indiana, United States
Background

In participants with type 2 diabetes and moderate-to-severe chronic kidney disease (CKD), in the AWARD-7 trial, treatment with dulaglutide (DU) compared to insulin glargine (IG) led to slower estimated glomerular filtration rate (eGFR) decline at similar levels of glycemic control and blood pressure.

Methods

To determine risk of a composite endpoint of ≥40% eGFR decline or end-stage kidney disease (ESKD) by albuminuria status, this post hoc analysis used Cox proportional hazards modeling for time to first event. Participants were randomized (1:1:1) to DU 0.75 mg or 1.5 mg weekly versus titrated IG daily for one year. eGFR was calculated using the CKD-epidemiology (EPI) creatinine and cystatin C equations.

Results

At baseline, treatment groups had similar eGFR within albuminuria subgroups (Table). Through the 1-year treatment period, the majority of events occurred in patients with macroalbuminuria; the incidence rate of the composite endpoint was significantly lower for DU 1.5 mg compared to IG in those with macroalbuminuria (Table). Consistent results were obtained when eGFR was calculated using either CKD-EPI creatinine or cystatin C equations.

Conclusion

The risk of the composite endpoint of ≥40% eGFR decline or ESKD was lower by approximately half for DU 1.5 mg compared to IG, which was mainly driven by effects in participants with macroalbuminuria.

Baseline Characteristics
(mean±SD)
Dulaglutide
1.5 mg
N=192
Dulaglutide
0.75 mg
N=190
Insulin
glargine
N=194
eGFR (mL/min/1.73m2)a
UACR <30
UACR 30-300
UACR >300
38.1±13.2
43.8±13.0
40.2±12.6
34.0±12.8
38.3±12.3
44.2±9.0
38.9±12.5
35.0±12.6
38.5±13.0
42.9±12.5
42.0±11.8
33.9±12.6
≥40% eGFR decline or ESKD events
(a. CKD-EPI creatinine; b. CKD-EPI cystatin C)
n/N
(%)
HR
(95%CI)
n/N
(%)
HR
(95%CI)
n/N
(%)
Overalla.10/192
(5.2)
0.45
(0.20, 0.97)*
16/190
(8.4)
0.79
(0.41, 1.51)
21/194
(10.8)
b.11/192
(5.7)
0.49
(0.23, 1.04)
15/190
(7.9)
0.73
(0.38, 1.42)
21/194
(10.8)
Normal
UACR <30 mg/g
a.2/34
(5.9)
NA0/44
(0.0)
NA0/48
(0.0)
b.3/34
(8.8)
NA0/44
(0.0)
NA1/48
(2.1)
Microalbuminuria
UACR 30-300 mg/g
a.2/74
(2.7)
1.59
(0.14, 17.48)
2/61
(3.3)
1.96
(0.18, 21.66)
1/56
(1.8)
b.2/74
(2.7)
1.59
(0.14, 17.48)
2/61
(3.3)
1.96
(0.18, 21.66)
1/56
(1.8)
Macroalbuminuria
UACR >300 mg/g
a.6/84
(7.1)
0.25
(0.10, 0.68)*
14/84
(16.7)
0.72
(0.36, 1.43)
20/90
(22.2)
b.6/84
(7.1)
0.26
(0.10, 0.71)*
13/84
(15.5)
0.70
(0.34, 1.41)
19/90
(21.1)

aCKD-EPI creatinine; CI=confidence interval; HR=hazard ratio; N=total number, n=number with composite outcome; NA = not applicable; UACR=urinary albumin/creatinine ratio. *p<0.05 versus insulin glargine

Funding

  • Commercial Support