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- Title
Efficacy and Safety of Liraglutide Versus Placebo as Add-on to Glucose-Lowering Therapy in Patients With Type 2 Diabetes and Moderate Renal Impairment (LIRA-RENAL): A Randomized Clinical Trial.
- Authors
Davies, Melanie J.; Bain, Stephen C.; Atkin, Stephen L.; Rossing, Peter; Scott, David; Shamkhalova, Minara S.; Bosch-Traberg, Heidrun; Syrén, Annika; Umpierrez, Guillermo E.
- Abstract
<bold>Objective: </bold>Renal impairment in type 2 diabetes limits available glucose-lowering treatment options. This trial was conducted to establish the efficacy and safety of liraglutide as an add-on to existing glucose-lowering medications in patients with inadequately controlled type 2 diabetes and moderate renal impairment.<bold>Research Design and Methods: </bold>In this 26-week, double-blind trial, 279 patients with HbA1c 7-10%, BMI 20-45 kg/m(2), and moderate renal impairment (estimated glomerular filtration rate [eGFR] 30-59 mL/min/1.73 m(2); MDRD) were randomized (1:1) to once-daily liraglutide 1.8 mg (n = 140) or placebo (n = 139).<bold>Results: </bold>The estimated treatment difference in HbA1c from baseline to week 26 was -0.66% (-7.25 mmol/mol) (95% CI -0.90 to -0.43 [-9.82 to -4.69]), P < 0.0001). Fasting plasma glucose decreased more with liraglutide (-1.22 mmol/L [-22.0 mg/dL]) than with placebo (-0.57 mmol/L [-10.3 mg/dL], P = 0.036). There was a greater reduction in body weight with liraglutide (-2.41 kg) than with placebo (-1.09 kg, P = 0.0052). No changes in renal function were observed (eGFR relative ratio to baseline: -1% liraglutide, +1% placebo; estimated treatment ratio [ETR] 0.98, P = 0.36). The most common adverse events were gastrointestinal (GI) adverse effects (liraglutide, 35.7%; placebo, 17.5%). No difference in hypoglycemic episodes was observed between treatment groups (event rate/100 patient-years of exposure: liraglutide, 30.47; placebo, 40.08; P = 0.54). The estimated ratio to baseline for lipase was 1.33 for liraglutide and 0.97 for placebo (ETR 1.37, P < 0.0001).<bold>Conclusions: </bold>Liraglutide did not affect renal function and demonstrated better glycemic control, with no increase in hypoglycemia risk but with higher withdrawals due to GI adverse events than placebo in patients with type 2 diabetes and moderate renal impairment.
- Subjects
PHYSIOLOGICAL effects of hypoglycemic agents; DRUG efficacy; PLACEBOS; TREATMENT of diabetes; KIDNEY disease treatments; TYPE 2 diabetes complications; BLOOD sugar; BODY weight; COMBINATION drug therapy; COMPARATIVE studies; DRUG administration; GASTROINTESTINAL system; HYPOGLYCEMIA; HYPOGLYCEMIC agents; RESEARCH methodology; MEDICAL cooperation; TYPE 2 diabetes; KIDNEY failure; RESEARCH; EVALUATION research; RANDOMIZED controlled trials; BLIND experiment; DISEASE complications
- Publication
Diabetes Care, 2016, Vol 39, Issue 2, p222
- ISSN
0149-5992
- Publication type
journal article
- DOI
10.2337/dc14-2883