title: Linagliptin added to sulphonylurea in uncontrolled type 2 diabetes patients with moderate-to-severe renal impairment.
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.
authors.affiliation: Division of Endocrinology, Metabolism and Lipid Research, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.
authors.forename: Janet B
authors.initials: JB
authors.lastname: McGill
authors.forename: Anthony H
authors.initials: AH
authors.lastname: Barnett
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Lewin
authors.forename: Sanjay
authors.initials: S
authors.lastname: Patel
authors.forename: Dietmar
authors.initials: D
authors.lastname: Neubacher
authors.forename: Maximilian
authors.initials: M
authors.lastname: von Eynatten
authors.forename: Hans-Juergen
authors.initials: HJ
authors.lastname: Woerle
mesh_terms: D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D003928:Diabetic Nephropathies / Q000139:chemically induced / Q000503:physiopathology*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D016903:Drug Monitoring; D004351:Drug Resistance; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control; D007003:Hypoglycemia / Q000139:chemically induced / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007668:Kidney / Q000187:drug effects / Q000503:physiopathology; D000069476:Linagliptin; D008297:Male; D008875:Middle Aged; D011687:Purines / Q000009:adverse effects / Q000627:therapeutic use*; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D051436:Renal Insufficiency, Chronic / Q000139:chemically induced / Q000150:complications / Q000503:physiopathology; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013453:Sulfonylurea Compounds / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069476:Linagliptin; D011687:Purines; D011799:Quinazolines; D013453:Sulfonylurea Compounds; C517652:hemoglobin A1c protein, human
keywords: Linagliptin; efficacy; renal impairment; safety; sulphonylurea; type 2 diabetes