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.

Interessenskonflikt

Disclosure:

This study was funded by Eli Lilly and Company.

KT is the consultant for Eli Lilly and Company, Boehringer Ingelheim, AstraZeneca, Gilead and Goldfinch Bio. MCL, DBW, AK, MK, FTB were employees and shareholders of Eli Lilly and Company during the time when the study was conducted and analyzed. BR received speaker honoraria from Astra-zeneca, Eli Lilly, Sanofi and Boehringer-Ingelheim, and served on an advisory board for Astra-zeneca and Boehringer-Ingelheim.

Previously presented at ADA (2019) American Diabetes Association - 79th Annual Scientific Sessions; San Francisco, CA, USA; June 7-11, 2019.

Joerg Baeumler is employee of Lilly Deutschland GmbH and minor shareholder of the company.

Publication History

Article published online:
06 May 2021