Author(s): McGill JB, Barnett AH, Lewin AJ, Patel S, Neubacher D,
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Abstract Glucose-lowering treatment options are limited for uncontrolled type 2 diabetes mellitus (T2DM) patients with advanced stages of renal impairment (RI). This retrospective analysis evaluated glycaemic efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor linagliptin added to sulphonylurea. Three randomized phase 3 studies (n = 619) including T2DM subjects with moderate or severe RI [estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m²] were analysed; only sulphonylurea-treated subjects who received additional linagliptin (n = 58) or placebo (n = 33) were evaluated. Linagliptin provided meaningful placebo-adjusted HbA1c reductions of -0.68\% (95\% confidence interval: -1.19, -0.17), -1.08\% (-2.02, -0.14) and -0.62\% (-1.25, 0.01) after 24, 18 and 12 weeks, respectively. There was a similar incidence of overall adverse events (linagliptin: 79.3\%, placebo: 75.8\%) and hypoglycaemia (linagliptin: 37.9\%, placebo: 39.4\%). Severe hypoglycaemia was more common with placebo (linagliptin: 1.7\%, placebo: 6.1\%). These data suggest that linagliptin is a safe and effective glucose-lowering treatment in T2DM patients with moderate-to-severe RI for whom sulphonylurea treatment is no longer sufficient. TRIAL REGISTRATION: ClinicalTrials.gov NCT00800683 NCT00819091 NCT01084005.
This article was published in Diab Vasc Dis Res
and referenced in Journal of Diabetes & Metabolism