Chronic Kidney Disease (CKD) Outcomes with Dulaglutide (DU) Versus Insulin Glargine (IG) in Type 2 Diabetes (T2D) and Moderate-to-Severe CKD by Albuminuria Status: AWARD-7

Background In AWARD-7 study, DU treatment was associated with slower eGFR decline in patients with T2 D and moderate-to-severe CKD vs. IG. This analysis assessed CKD outcomes with DU vs. IG.

Methods Participants with T2 D and CKD stages 3-4 were randomized (1:1:1) to DU 0.75 mg or 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 trial. Participants experiencing ≥40 % eGFR decline, end-stage renal disease (ESRD), or death fromkidney-related causes were compared between groups as composite and individual outcomes. Time-to-event analysis for composite outcome was conducted with Cox proportional hazards model.

Results 48 % were women and baseline characteristics (mean[SD]) were: Age 64.5(8.5)years, Diabetes duration 18.1(8.8)years, eGFR 38(13)mL/min/1.73m2 and urine albumin-creatinine ratio (median [interquartile range]) 209(39;965)g/kg. HbA1c declined similarly in all groups (mean ~1 % over 1 year). Composite outcome experienced by 47 / 576 (8.2 %) participants: [10 / 192 (5.2 %) DU 1.5 mg, and 16 / 190 (8.4 %) DU 0.75 mg vs. 21 / 194 (10.8 %) IG, (p = 0.046 and 0.548 vs. IG, respectively)]. Time-to-event for composite outcome was significantly better for DU 1.5 mg vs. IG (Cox model; p = 0.038). eGFR decline ≥40 %: 2 / 192 (1.0 %) DU 1.5 mg, 7 / 190 (3.7 %) DU 0.75 mg, and 6 / 194 (3.1 %) IG. Proportions reaching ESRD: 8/187 (4.3 %) DU 1.5 mg, 14 / 184 (7.6 %) DU 0.75 mg, and 16 / 191 (8.4 %) IG. Between-group comparisons were not significant for these individual outcomes. Kidney-related deaths were not reported.

Conclusion 1-year treatment with DU 1.5 mg was associated with lower rate of CKD outcomes, including eGFR decline ≥ 40 % and ESRD, vs. IG at similar levels of glycemic control.

Publication History

Article published online:
06 May 2021