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Comparative effectiveness of gliclazide modified release vs sitagliptin as second-line treatment after metformin monotherapy in patients with uncontrolled type 2 diabetes.

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journal contribution
posted on 10.03.2021, 09:55 by Francesco Zaccardi, Emmanuelle Jacquot, Viviana Cortese, Freya Tyrer, Samuel Seidu, Melanie J Davies, Kamlesh Khunti
Aims
To compare the effectiveness and safety of gliclazide modified release (MR) to sitagliptin as type 2 diabetes mellitus (T2D) treatments in a real‐world patient population.

Materials and Methods
This retrospective cohort study used records from the UK Clinical Practice Research Datalink. The cohort consisted of adult patients with T2D newly treated with either gliclazide MR or sitagliptin as second‐line treatment added to metformin and with a glycated haemoglobin (HbA1c) level of ≥7.0% (53 mmol/mol). Patients were 1:1 matched using high‐dimensional propensity score matching and followed to determine the time taken to reach an HbA1c <7.0%. Secondary outcomes included time to HbA1c ≤6.5% (48 mmol/mol), time to ≥1% (11 mmol/mol) HbA1c reduction from baseline, treatment persistence and durability, and hypoglycaemic events.

Results
Among the 1986 patients included, those on gliclazide MR more likely achieved an HbA1c <7.0% [hazard ratio (HR): 1.35; 95% confidence interval (CI): 1.15‐1.57], HbA1c ≤6.5% (HR: 1.51; 95% CI: 1.19‐1.92) or had an HbA1c reduction ≥1% from baseline (HR: 1.11; 95% CI: 1.00‐1.24) compared with patients on sitagliptin. Durability (log‐rank P = .135) and persistence (P = .119) were similar between the two groups. Hypoglycaemic events were uncommon (23 total severe and non‐severe events; incidence rate, 3.7 per 1000 patient years), with 4.7 and 2.6 events per 1000 patient years with gliclazide MR and sitagliptin treatment, respectively.

Conclusions
In this real‐world study, second‐line gliclazide MR was more effective than sitagliptin in reducing HbA1c, with similar durability and persistence and low rates of hypoglycaemic events, in individuals with T2D on metformin treatment and HbA1c above the target of 7.0%.

Funding

National Institute for Health Research Applied Research Collaborations – East Midlands (NIHR ARC – EM) and the NIHR Leicester Biomedical Research Centre.

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History

Citation

Diabetes, obesity & metabolism, Volume 22, Issue 12, December 2020, Pages 2417-2426

Author affiliation

Diabetes Research Centre, College of Life Sciences

Version

VoR (Version of Record)

Published in

Diabetes, obesity & metabolism

Volume

22

Issue

12

Pagination

2417-2426

Publisher

Wiley

issn

1462-8902

eissn

1463-1326

Acceptance date

03/08/2020

Copyright date

2020

Available date

09/09/2020

Spatial coverage

England

Language

eng