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
- SGLT-2 Inhibitors and Diabetic Kidney Disease
November 03, 2017 | Location: Room 282, Morial Convention Center
Abstract Time: 04:30 PM - 04:42 PM
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 Group | All (N=576) | UACR >300 mg/g (n=258) | UACR ≤300 mg/g (n=317) | |||
Δ eGFR, mL/min/1.73m2 | %Δ UACR | Δ eGFR, mL/min/1.73m2 | %Δ UACR | Δ 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 – Eli Lilly and Company