Abstract BP-1
COMPARABLE GLYCEMIC CONTROL WITH ONCE WEEKLY DULAGLUTIDE VERSUS INSULIN GLARGINE, BOTH COMBINED WITH LISPRO, IN TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE (AWARD-7) 1
THOMAS LEW (PRESENTER ONLY), 2KATHERINE R. TUTTLE, 3MARK C. LAKSHMANAN, 4BRIAN RAYNER, 5ROBERT S. BUSCH, 3D. BRADLEY WOODWARD, 3ALAN G. ZIMMERMANN, 3FADY T. BOTROS 1
Presenting on behalf of Eli Lilly and Company, Indianapolis, IN, USA;2Providence Health Care, University of Washington, Spokane, WA, USA;3Eli Lilly and Company, Indianapolis, IN, USA;4Division of Nephrology and Hypertension, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa;5Albany Medical Center Division of Community Endocrinology, Albany, NY, USA
Background: This phase 3 study compared once-weekly dulaglutide (DU) to titrated daily insulin glargine (IG), both combined with insulin lispro, in type 2 diabetes (T2D) patients with moderate-tosevere chronic kidney disease (CKD) stages 3-4. Methods: Participants were randomised (1:1:1) to DU 1.5mg or DU 0.75mg or IG. Objective: To demonstrate DU noninferiority for A1c change from baseline at 26 weeks. Results: Baseline characteristics (N = 576) included: [mean ± SD] age 64.6 ± 8.6years, A1c 8.6 ± 1.0%, eGFR 38.3 ± 12.8mL/min/1.73m2, BMI 32.5 ± 5.2kg/m2, daily insulin dose 58.2 ± 31.8 units. DU was non-inferior to IG for A1c change from baseline at 26 weeks (LSM (SE); -1.2 (0.1)% DU 1.5mg and -1.1 (0.1)% DU 0.75mg, versus -1.1 (0.1)% IG; 1-sided p < 0.001 for both DU doses versus IG); similar results were observed at 52 weeks. Body weight decreased with DU and increased with IG (at 52 weeks: -2.7 (0.5)kg DU 1.5mg and -1.7 (0.4)kg DU 0.75mg, versus +1.6 (0.4)kg IG, 2-sided p < 0.001). The hypoglycaemia rate (glucose ≤ 70 mg/dL) was lower with DU 1.5mg and 0.75mg versus IG (at 52 weeks: 5.8, 7.6 versus 14.4 events/participant/year; p < 0.001, p = 0.004, respectively). Severe hypoglycaemia was less in DU 1.5mg compared to IG (0 in DU 1.5mg, 5 [2.6%] in DU 0.75mg, and 13 [6.7%] in IG). Nausea, vomiting and diarrhea were more common with DU 1.5mg (19.8%, 13.5%, 17.2%) and 0.75mg (14.2%, 8.4%, 15.8%) versus IG (4.6%, 4.6%, 7.2%). Conclusions: DU produced comparable glycaemic control, greater weight loss, and lower hypoglycaemia rate versus IG in T2D patients with CKD stage 3-4, with the anticipated gastrointestinal side effects.
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