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Abstract: TH-PO0363

Effect of Semaglutide on Hemoglobin A1c and Body Weight Change by CKD Stage: Post Hoc Analysis from the FLOW Trial

Session Information

Category: Diabetic Kidney Disease

  • 702 Diabetic Kidney Disease: Clinical

Authors

  • Friedman, Allon N., Indiana University School of Medicine, Indianapolis, Indiana, United States
  • Pratley, Richard E., AdventHealth Translational Research Institute, Orlando, Florida, United States
  • Tuttle, Katherine R., Providence Medical Research Center, Spokane, Washington, United States
  • Mehanna, Sherif, Novo Nordisk Inc, Plainsboro, New Jersey, United States
  • Swift, Caroline, Novo Nordisk Inc, Plainsboro, New Jersey, United States
  • Rasmussen, Soren, Novo Nordisk A/S, Søborg, Capital Region of Denmark, Denmark
  • Rossing, Peter, Steno Diabetes Center Copenhagen, Herlev, Capital Region of Denmark, Denmark
  • Perkovic, Vlado, University of New South Wales, Sydney, New South Wales, Australia
  • Mahaffey, Kenneth W., Stanford Center for Clinical Research, Stanford, California, United States
  • Basile, Jan N., Medical University of South Carolina, Charleston, South Carolina, United States
Background

In the FLOW randomized clinical trial (NCT03819153), semaglutide reduced major kidney outcomes by 24% compared with placebo in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). In this post hoc analysis of prespecified secondary outcomes of the FLOW trial, we aimed to assess changes in glycated hemoglobin (HbA1c) and body weight from baseline to 104 weeks across stages of CKD in patients with CKD and T2D.

Methods

The FLOW trial included patients aged ≥18 years with CKD and T2D. The effect of semaglutide 1 mg vs placebo, both in addition to the standard of care, on change in HbA1c and body weight from baseline to week 104 was assessed for subgroups categorized by baseline estimated glomerular filtration rate (eGFR, ≥60 [stage 2], ≥45-<60 [stage 3a], ≥30-<45 [stage 3b], <30 [stage 4] mL/min/1.73 m2). Outcomes were analyzed using ANCOVA with baseline eGFR as a covariate and an interaction term for treatment group by eGFR category. Estimated treatment differences (ETD) between treatment and placebo groups were calculated. Multiple imputation was used to impute missing values under a missing-at-random assumption.

Results

Of the 3,533 patients in the FLOW trial, 3,271 and 3,270 had data available for calculating change in HbA1c and body weight, respectively. Across CKD stages, patients treated with semaglutide 1 mg had a greater reduction in HbA1c than patients treated with placebo from baseline to week 104 (ETD range across CKD stages: –0.7% to –0.9%, all p<0.0001, Table 1). Similarly, across CKD stages, patients treated with semaglutide had a greater reduction in body weight from baseline to week 104 (ETD range across CKD stages: –3.5 to –4.6 kg, all p<0.0001). The effect of treatment did not significantly differ by eGFR at baseline (interaction p=0.4709 for HbA1c and interaction p=0.4891 for body weight).

Conclusion

Across CKD stages, patients treated with semaglutide 1 mg had greater reductions in HbA1c and body weight from baseline to week 104, compared with placebo. The effect of treatment was similar across categories of eGFR measured at baseline.

Funding

  • Commercial Support – Novo Nordisk Inc.

Digital Object Identifier (DOI)