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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)
1Presenting 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.
BP-2 DULAGLUTDE TREATMENT IS ASSOCIATED WITH LESS EGFR DECLINE AND GREATER REDUCTION IN ALBUMINURIA IN TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE STAGE 3-4 (AWARD-7)
1Presenting 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
Introduction: In short-term studies, dulaglutide (DU) reduced albuminuria and did not change estimated glomerular filtration rate (eGFR) in type 2 diabetes (T2D) patients with normal kidney function. Methods: The AWARD-7 phase 3 trial compared weekly DU (1.5 or 0.75 mg) to daily insulin glargine (IG), both with insulin lispro, in participants with T2D and chronic kidney disease (CKD) stages 3-4. Results: Baseline (BL) characteristics (N = 576) were: eGFR CKD-Epidemiology Collaboration: 38 ± 13 mL/min/1.73 m2 (mean ± SD), urine albumin/creatinine ratio (UACR, mean [median]): 847.2 mg/g (209.3 mg/g), age: 65 ± 9 years, A1c: 8.6 ± 1.0%, duration of T2D: 18 ± 9 years. After 52 weeks, glycemic control was similar for the three treatment arms, both doses of DU proving noninferior to IG for the change in A1c. Mean eGFR (mL/min/1.73 m2 [95% confidence interval]) was not statistically different from BL with DU 1.5 mg (-1.1 [-2.04, 0.2]), while it decreased with DU 0.75 mg (-1.5 [-2.08, -0.2], 2-sided p300 mg/g (N = 258). 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.
BP-3 STEADY STATE BLOOD GLUCOSE CONTROL FOR ONCE WEEKLY DULAGLUTIDE DURING PEAK AND TROUGH CONCENTRATION DAYS
1THOMAS LEW (PRESENTER ONLY), 2HIREN PATEL
1Presenting on behalf of Eli Lilly and Company, Indianapolis, USA; 2Lilly USA, LLC; Indianapolis, IN, USA; 3Eli Lilly and Company, Indianapolis, IN, USA; 4Lilly-NUS Centre for Clinical Pharmacology, Singapore
Background Dulaglutide (DU), a GLP-1 receptor agonist with a half-life of ~5 days, is administered once weekly in patients with type 2 diabetes. In this post hoc analysis of AWARD-3, the sustainability of DU glycemic effect over a 7-day interval at steady state (attained between 2-4 weeks of dosing) was assessed. AWARD-3 was considered for this analysis as it was the only monotherapy study of DU. Methods Within 1 week prior to the Week 26 visit, patients were asked to collect 8-point self-monitored blood glucose (SMBG) profiles on any 2 non-consecutive days. All evaluable SMBG profiles with valid dosing dates were segregated according to Days 1-7 of a dosing interval. SMBG data on DU peak (Day 2/3) and trough (Day 6/7) plasma concentration days were tested for equivalence. A mixed effect model with random intercept and the time of SMBG collection (peak/trough) as a single covariate, was fitted for statistical analysis. Results Mean daily SMBG concentrations were found to be equivalent between DU peak and trough days for both doses (Table). Model-predicted DU concentrations (90% prediction interval) also remained above the minimum effective concentration throughout the 7-day period. Conclusion Throughout the weekly dosing interval at steady state, DU has a similar effect on blood glucose control during peak and trough plasma concentration days, as assessed by the change in mean daily SMBG concentrations.
