Bernt Johan von Scholten1, Melanie J Davies2, Frederik Persson3, Tine W Hansen4, Sten Madsbad5, Lars Endahl6, Cecilie H Jepsen7, Peter Rossing8. 1. Steno Diabetes Center Copenhagen, Region H, Copenhagen, Denmark. Electronic address: BJOS@novonordisk.com. 2. Diabetes Research Centre, University of Leicester, Leicester, UK. Electronic address: melanie.davies@uhl-tr.nhs.uk. 3. Steno Diabetes Center Copenhagen, Region H, Copenhagen, Denmark. Electronic address: frederik.ivar.persson@regionh.dk. 4. Steno Diabetes Center Copenhagen, Region H, Copenhagen, Denmark. Electronic address: Tine.Willum.Hansen@regionh.dk. 5. Hvidovre University Hospital, Denmark. Electronic address: Sten.Madsbad@regionh.dk. 6. Novo Nordisk, Søborg, Denmark. Electronic address: LAEN@novonordisk.com. 7. Novo Nordisk, Søborg, Denmark. Electronic address: CCEJ@novonordisk.com. 8. Steno Diabetes Center Copenhagen, Region H, Copenhagen, Denmark; University of Copenhagen, Copenhagen, Denmark; Aarhus University, Aarhus, Denmark. Electronic address: peter.rossing@regionh.dk.
Abstract
AIMS: Weight loss-induced serum creatinine reduction may increase creatinine-based estimated glomerular filtration rate (eGFR) producing incorrect estimates of kidney function. We investigated whether weight changes in the SCALE program with liraglutide 3.0mg were associated with changes in serum creatinine. METHODS: Post hoc analysis of two 56-week, randomized, double-blind trials: SCALE Obesity and Prediabetes (n=3731, without type 2 diabetes [T2D], randomized [2:1] to liraglutide 3.0mg [n=2487] or placebo [n=1244]); SCALE Diabetes (n=846 with T2D, randomized [2:1:1] to liraglutide 3.0mg [n=423], 1.8mg [n=211, excluded from this analysis] or placebo [n=212]). NCT01272219/NCT01272232. RESULTS: In SCALE Obesity and Prediabetes, mean (±SD) weight loss (baseline to week 56) with liraglutide was 8.0±6.7% (2.6±6.9% with placebo); baseline creatinine with liraglutide was 76±15μmol/L and 74±15μmol/L after 56weeks (similar across treatment groups). In SCALE Diabetes, weight loss with liraglutide was 5.9±5.5% (2.0±4.3% with placebo); baseline creatinine was 79±19μmol/L (77±16μmol/L, placebo) and 79±20μmol/L after 56weeks (76±15μmol/L, placebo). No association between changes in weight and changes in serum creatinine was observed (P≥0.05, both trials, all tests). CONCLUSIONS:Moderate gradual body weight reductions observed in the SCALE program were not associated with changes in serum creatinine.
RCT Entities:
AIMS: Weight loss-induced serum creatinine reduction may increase creatinine-based estimated glomerular filtration rate (eGFR) producing incorrect estimates of kidney function. We investigated whether weight changes in the SCALE program with liraglutide 3.0mg were associated with changes in serum creatinine. METHODS: Post hoc analysis of two 56-week, randomized, double-blind trials: SCALE Obesity and Prediabetes (n=3731, without type 2 diabetes [T2D], randomized [2:1] to liraglutide 3.0mg [n=2487] or placebo [n=1244]); SCALE Diabetes (n=846 with T2D, randomized [2:1:1] to liraglutide 3.0mg [n=423], 1.8mg [n=211, excluded from this analysis] or placebo [n=212]). NCT01272219/NCT01272232. RESULTS: In SCALE Obesity and Prediabetes, mean (±SD) weight loss (baseline to week 56) with liraglutide was 8.0±6.7% (2.6±6.9% with placebo); baseline creatinine with liraglutide was 76±15μmol/L and 74±15μmol/L after 56weeks (similar across treatment groups). In SCALE Diabetes, weight loss with liraglutide was 5.9±5.5% (2.0±4.3% with placebo); baseline creatinine was 79±19μmol/L (77±16μmol/L, placebo) and 79±20μmol/L after 56weeks (76±15μmol/L, placebo). No association between changes in weight and changes in serum creatinine was observed (P≥0.05, both trials, all tests). CONCLUSIONS: Moderate gradual body weight reductions observed in the SCALE program were not associated with changes in serum creatinine.