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Diabetes Obes Metab. 2018 Nov 20. doi: 10.1111/dom.13587. [Epub ahead of print]

Glycaemic Efficacy and Safety of Linagliptin compared to Basal-Bolus Insulin Regimen in Patients with Type 2 Diabetes Undergoing Non-Cardiac Surgery: A Multicenter Randomized Clinical Trial.

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Division of Endocrinology, Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, GA.
Division of Endocrinology, University of Colorado-Denver, Denver, CO.
Division of Endocrinology, Rush University Medical Center, Chicago, IL.
Division of Endocrinology, Boston University, Boston, MA.
Department of Biostatistics, Rollins School of Public Health, Emory University, Atlanta, GA.



The use of incretin-based therapy instead of or complementary to insulin therapy is an active area of research in hospitalized patients with type 2 diabetes (T2D). We determined glycaemic efficacy and safety of linagliptin compared to basal-bolus insulin regimen in hospitalized surgical patients with T2D.


This prospective open-label multicenter study randomized T2D patients undergoing non-cardiac surgery with admission blood glucose(BG) 7.8-22.2 mmol/L treated with diet, oral agents or total insulin dose(TDD) ≤0.5 units/kg/day to linagliptin(n=128) daily or basal-bolus(n=122) with glargine once daily and rapid-acting insulin before meals. Both groups received supplemental insulin for BG>7.8 mmol/L. The primary endpoint was difference in mean daily BG between groups.


Mean daily BG was inferior in linagliptin compared to basal-bolus group (9.5±2.6 vs. 8.8±2.3 mmol/L/dL, p=0.03) with mean daily BG difference of 0.6mmol/L (95% confidence interval 0.04, 1.2). In patients with randomization BG<11.1 mmol/L (63% of cohort), mean daily BG was similar in linagliptin vs basal-bolus (8.9±2.3 vs. 8.7±2.3 mmol/L, p=0.43); however, patients with BG≥11.1 mmol/L treated with linagliptin had higher BG compared to basal-bolus (10.9±2.6 vs. 9.2±2.2 mmol/L, p<0.001). Linagliptin resulted in fewer hypoglycaemic events (1.6% vs. 11%, p=0.001, 86% relative risk reduction), similar supplemental insulin (and lower number of daily insulin injections (2.0±3.3 vs 3.1±3.3, p<0.001) compared to basal-bolus.


In patients with T2D undergoing non-cardiac surgery presenting with mild to moderate hyperglycaemia (BG <11.1 mmol/L), daily linagliptin is a safe and effective alternative to multi-dose insulin therapy resulting in similar glucose control with lower hypoglycaemia. This article is protected by copyright. All rights reserved.


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