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Regardless of the degree of glycaemic control, linagliptin has lower hypoglycaemia risk than all doses of glimepiride, at all time points, over the course of a 2‐year trial
Author(s) -
Gallwitz B.,
Rosenstock J.,
Patel S.,
von Eynatten M.,
Hehnke U.,
Mehlburger L.,
Dugi K. A.,
Woerle H.J.
Publication year - 2015
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12419
Subject(s) - glimepiride , linagliptin , medicine , type 2 diabetes , metformin , incidence (geometry) , hypoglycemia , diabetes mellitus , gastroenterology , endocrinology , physics , optics
Aim To evaluate the risk of documented hypoglycaemia with glimepiride versus linagliptin. Methods This was an exploratory analysis of data from a 2‐year, randomized, double‐blind study of the dipeptidyl peptidase‐4 inhibitor linagliptin 5 mg once daily (n = 764) versus the sulphonylurea glimepiride 1–4 mg once daily (n = 755) in patients with type 2 diabetes uncontrolled by metformin. Patients randomized to glimepiride started on 1 mg and after 4 weeks were allowed to be individually uptitrated stepwise to glimepiride 4 mg if a fasting plasma glucose concentration ≤6.1 mmol/l was not achieved. Investigator‐reported hypoglycaemia was evaluated by dose, over time, and by the degree of glycated haemoglobin ( HbA1c ) reduction. Results The percentages of patients with at least one hypoglycaemic event at the individual maximum glimepiride dose were: 1 mg, 45.0%; 2 mg, 50.8%; 3 mg, 36.1%; and 4 mg, 27.7%. The incidence of hypoglycaemia was higher with glimepiride than with linagliptin (36.1 vs. 7.5%; p < 0.0001); after performing sensitivity analyses by excluding events during dose escalation (weeks 0–16), this difference remained significant (weeks 16–104: 25.8 vs. 5.9%; p < 0.0001). Notably, the incidence of hypoglycaemia was higher with glimepiride than with linagliptin in each quartile of HbA1c change from baseline (all p < 0.0001); the incidence of hypoglycaemic episodes was not increased with greater reductions in HbA1c in either group. In all 4‐week intervals across the 2‐year study, the incidence of hypoglycaemia was lower with linagliptin than with glimepiride. Conclusion Linagliptin was associated with a lower risk of hypoglycaemia than glimepiride at all dose levels and time intervals, and regardless of change in HbA1c level.