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Risk of hypoglycaemia in people aged ≥65 years receiving linagliptin: pooled data from 1489 individuals with type 2 diabetes mellitus

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journal contribution
posted on 16.04.2020, 09:16 by Michael Nauck, Atsushi Araki, Uwe Hehnke, Arian Plat, Douglas Clark, Kamlesh Khunti
Aims: To investigate the risk of hypoglycaemia in people aged ≥65 years with type 2 diabetes mellitus (T2DM) treated with linagliptin, in the largest pooled analysis performed to date. Materials and methods: One thousand four hundred and eighty-nine patients aged ≥65 years with T2DM were pooled from 11 randomised, double-blind, parallel group, placebo-controlled trials evaluating linagliptin 5 mg alone, or in addition to various background therapies. The primary safety endpoint was the incidence of investigator-defined hypoglycaemia. Results: There was no significant difference in the risk of hypoglycaemia between linagliptin and placebo in the all-patient population at 24 weeks (hazard ratio [HR] 1.07; 95% confidence interval [CI]: 0.84, 1.36; P = 0.5943)—despite significant (P < 0.0001) improvements in glycaemic control—and 1 year (HR 1.02; 95% CI: 0.81, 1.27; P = 0.8803). Similar findings were observed for linagliptin vs placebo in subgroup analyses by background medication (eg, sulphonylureas (SUs) and/or insulin vs no such drugs), age, baseline glycated haemoglobin (HbA1c), ethnicity, and baseline estimated glomerular filtration rate. Patients with a baseline HbA1c ≥7.5% had significantly higher odds of achieving HbA1c <7.5% without hypoglycaemia in the linagliptin group compared with placebo at 24 weeks (34.1% vs 13.7%; 95% CI: 2.04, 4.12; P < 0.0001). Conclusions: This pooled analysis indicates that linagliptin was effective in treating older people with T2DM towards their HbA1c targets with a favourable safety and tolerability profile and low risk of hypoglycaemia. The safety profile was maintained even on background therapies with known risk of hypoglycaemia, such as insulin and SU.

Funding

Boehringer Ingelheim & Eli Lilly and Company Diabetes Alliance

History

Citation

International Journal of Clinical Practice, Volume72, Issue10, October 2018, e13240

Author affiliation

Diabetes Research Centre

Version

AM (Accepted Manuscript)

Published in

International Journal of Clinical Practice

Volume

72

Issue

10

Publisher

Wiley

issn

1368-5031

eissn

1742-1241

Acceptance date

03/07/2018

Copyright date

2018

Publisher version

https://onlinelibrary.wiley.com/doi/10.1111/ijcp.13240

Spatial coverage

England

Language

English