Linagliptin added to sulphonylurea in uncontrolled type 2 diabetes patients with
moderate-to-severe renal impairment.
Author(s): McGill JB(1), Barnett AH, Lewin AJ, Patel S, Neubacher D, von Eynatten M, Woerle
HJ.
Affiliation(s): Author information:
(1)Division of Endocrinology, Metabolism and Lipid Research, Washington University
in St. Louis School of Medicine, St. Louis, MO, USA.
Publication date & source: 2014, Diab Vasc Dis Res. , 11(1):34-40
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.
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