Poster Presentation Australian Diabetes Society and the Australian Diabetes Educators Association Annual Scientific Meeting 2014

Efficacy and safety of liraglutide versus placebo as add-on to existing diabetes medication in subjects with type 2 diabetes (T2DM) and moderate renal impairment (LIRA-RENAL) (#324)

Sabina Furber 1 , Melanie Davies 2 , Stephen Atkin 3 , Stephen Bain 4 , Peter Rossing 5 , David Scott 6 , Minara Shamkhalova 7 , Heidrun Bosch-Traberg 8 , Annika Syren 8 , Guillermo Umpierrez 9
  1. Novo Nordisk, Baulkham Hills, NSW, Australia
  2. Diabetes Research Centre, University of Leicester, Leicester, UK
  3. Weill Cornell Medical College Qatar, Qatar Foundation, Doha, Qatar
  4. Diabetes and Endocrinology, Abertawe Bro Morgannwg University NHS Trust, Swansea, UK
  5. Diabetes, Steno Research Center, Gentofte, Denmark
  6. Diabetes, Clinical Research Development Associates, Rosedale, NY, USA
  7. Diabetic Nephropathy, Endocrinology Research Centre, Moscow, Russia
  8. Novo Nordisk A/S, Soeborg, Denmark
  9. Endocrinology and Metabolism, Emory University, Atlanta, GA, USA

Renal impairment in T2DM limits the available antidiabetic treatment options. The rationale for this trial was to establish the efficacy and safety of liraglutide (lira) as add-on to existing OAD and/or insulin therapy in subjects with inadequately controlled T2DM and moderate renal impairment (Stage 3 CKD) (eGFR 30-59 mL/min/1.73 m2; MDRD). In this 26-week, double-blind, randomised study, subjects received either once-daily lira 1.8 mg or placebo with a primary endpoint of change in A1c from baseline (BL) to Week -26 (see Table). Liraglutide showed superior glycaemic control relative to placebo in subjects with Stage 3 CKD with a low risk of hypoglycemia and reduced body weight. The most common AEs were GI side effects, mostly nausea and vomiting which resolved quickly, (lira 35.7%, placebo 17.5%) and there was a higher incidence of AE leading to withdrawals in the lira group (13.6%) compared to placebo (2.9%). No deterioration in renal function was observed (eGFR change from BL: -1% lira; +1% placebo). In summary, liraglutide showed superior A1c and weight reduction with no unexpected safety or tolerability issues including no worsening of renal function in subjects with Stage 3 CKD over 26 weeks. The efficacy, low incidence of hypoglycaemia and safety of liraglutide in subjects with T2DM and Stage 3 CKD was demonstrated.