Combination of the dipeptidyl peptidase-4 inhibitor linagliptin with insulin-based regimens in type 2 diabetes and chronic kidney disease.
Glucose-lowering treatment options for type 2 diabetes mellitus patients with chronic kidney disease are limited. We evaluated the potential for linagliptin in combination with insulin in type 2 diabetes mellitus patients with mild-to-severe renal impairment. Data for participants in two phase 3 trials with linagliptin who were receiving insulin were analysed separately (n = 811). Placebo-adjusted mean HbA1c changes from baseline were -0.59% (mild renal impairment) and -0.69% (moderate renal impairment) after 24 weeks and -0.43% (severe renal impairment) after 12 weeks. Drug-related adverse events with linagliptin were similar to placebo (mild renal impairment: 19.9% vs. 26.5%; moderate renal impairment: 22.0% vs. 25.0%; severe renal impairment: 46.3% vs. 43.6%, respectively). Frequencies of hypoglycaemia in patients with mild, moderate and severe renal impairment were 34.9%, 35.6% and 66.7% with linagliptin and 37.5%, 39.7% and 49.1% with placebo, respectively. Episodes of severe hypoglycaemia were low (⩽5.6%). Adding linagliptin to insulin in type 2 diabetes mellitus patients with chronic kidney disease improved glucose control and was well tolerated.
Washington University School of Medicine in St Louis, St Louis, MO, USA JMCGILL@DOM.wustl.edu.
Janet B
JB
McGill
University of Helsinki, Helsinki, Finland.
Hannele
H
Yki-Järvinen
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Susanne
S
Crowe
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Hans-Juergen
HJ
Woerle
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Maximilian
M
von Eynatten
D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D003928:Diabetic Nephropathies / Q000209:etiology*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005919:Glomerular Filtration Rate; D006442:Glycated Hemoglobin / Q000378:metabolism; D065089:Glycoside Hydrolase Inhibitors / Q000627:therapeutic use; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D000069476:Linagliptin / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D000077205:Pioglitazone; D051436:Renal Insufficiency, Chronic / Q000209:etiology*; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013453:Sulfonylurea Compounds / Q000627:therapeutic use; D045162:Thiazolidinediones / Q000627:therapeutic use; D016896:Treatment Outcome
D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D065089:Glycoside Hydrolase Inhibitors; D007004:Hypoglycemic Agents; D007328:Insulin; D000069476:Linagliptin; D008687:Metformin; D000077205:Pioglitazone; D013453:Sulfonylurea Compounds; D045162:Thiazolidinediones; C517652:hemoglobin A1c protein, human
Type 2 diabetes mellitus; chronic kidney disease; dipeptidyl peptidase-4 inhibitor; linagliptin