Thomas Idorn1, Filip K Knop2, Morten B Jørgensen3, Tonny Jensen4, Marsela Resuli5, Pernille M Hansen5, Karl B Christensen6, Jens J Holst7, Mads Hornum3, Bo Feldt-Rasmussen3. 1. Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark thomas.idorn@regionh.dk. 2. Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark The Novo Nordisk Foundation Center for Basic Metabolic Research and Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. 3. Department of Nephrology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. 4. Department of Endocrinology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. 5. Department of Internal Medicine, Hillerød Hospital, University of Copenhagen, Hillerød, Denmark. 6. Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark. 7. The Novo Nordisk Foundation Center for Basic Metabolic Research and Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Abstract
OBJECTIVE: To evaluate parameters related to safety and efficacy of liraglutide in patients with type 2 diabetes and dialysis-dependent end-stage renal disease (ESRD). RESEARCH DESIGN AND METHODS: Twenty-four patients with type 2 diabetes and ESRD and 23 control subjects with type 2 diabetes and normal kidney function were randomly allocated to 12 weeks of double-blind liraglutide (titrated to a maximum dose of 1.8 mg) or placebo treatment (1:1) injected subcutaneously once daily as add on to ongoing antidiabetic treatment. Dose-corrected plasma trough liraglutide concentration was evaluated at the final trial visit as the primary outcome measure using a linear mixed model. RESULTS:Twenty patients with ESRD (1:1 forliraglutide vs. placebo) and 20 control subjects (1:1) completed the study period. Dose-corrected plasma trough liraglutide concentration at the final visit was increased by 49% (95% CI 6-109, P = 0.02) in the group with ESRD compared with the control group. Initial and temporary nausea and vomiting occurred more frequently among liraglutide-treated patients with ESRD compared with control subjects (P < 0.04). Glycemic control tended to improve during the study period in both liraglutide-treated groups as assessed by daily blood glucose measurements (P < 0.01), and dose of baseline insulin was reduced in parallel (P < 0.04). Body weight was reduced in both liraglutide-treated groups (-2.4 ± 0.8 kg [mean ± SE] in the group with ESRD, P = 0.22; -2.9 ± 1.0 kg in the control group, P = 0.03). CONCLUSIONS:Plasma liraglutide concentrations increased during treatment in patients with type 2 diabetes and ESRD, who experienced more gastrointestinal side effects. Reduced treatment doses and prolonged titration period may be advisable.
RCT Entities:
OBJECTIVE: To evaluate parameters related to safety and efficacy of liraglutide in patients with type 2 diabetes and dialysis-dependent end-stage renal disease (ESRD). RESEARCH DESIGN AND METHODS: Twenty-four patients with type 2 diabetes and ESRD and 23 control subjects with type 2 diabetes and normal kidney function were randomly allocated to 12 weeks of double-blind liraglutide (titrated to a maximum dose of 1.8 mg) or placebo treatment (1:1) injected subcutaneously once daily as add on to ongoing antidiabetic treatment. Dose-corrected plasma trough liraglutide concentration was evaluated at the final trial visit as the primary outcome measure using a linear mixed model. RESULTS: Twenty patients with ESRD (1:1 for liraglutide vs. placebo) and 20 control subjects (1:1) completed the study period. Dose-corrected plasma trough liraglutide concentration at the final visit was increased by 49% (95% CI 6-109, P = 0.02) in the group with ESRD compared with the control group. Initial and temporary nausea and vomiting occurred more frequently among liraglutide-treated patients with ESRD compared with control subjects (P < 0.04). Glycemic control tended to improve during the study period in both liraglutide-treated groups as assessed by daily blood glucose measurements (P < 0.01), and dose of baseline insulin was reduced in parallel (P < 0.04). Body weight was reduced in both liraglutide-treated groups (-2.4 ± 0.8 kg [mean ± SE] in the group with ESRD, P = 0.22; -2.9 ± 1.0 kg in the control group, P = 0.03). CONCLUSIONS: Plasma liraglutide concentrations increased during treatment in patients with type 2 diabetes and ESRD, who experienced more gastrointestinal side effects. Reduced treatment doses and prolonged titration period may be advisable.
Authors: Johannes F E Mann; Vivian A Fonseca; Neil R Poulter; Itamar Raz; Thomas Idorn; Søren Rasmussen; Bernt Johan von Scholten; Ofri Mosenzon Journal: Clin J Am Soc Nephrol Date: 2020-03-04 Impact factor: 8.237
Authors: José Luis Górriz; María José Soler; Juan F Navarro-González; Clara García-Carro; María Jesús Puchades; Luis D'Marco; Alberto Martínez Castelao; Beatriz Fernández-Fernández; Alberto Ortiz; Carmen Górriz-Zambrano; Jorge Navarro-Pérez; Juan José Gorgojo-Martinez Journal: J Clin Med Date: 2020-03-30 Impact factor: 4.241