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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.
Diabetes Obes Metab. 2018 Nov 20;:
Authors: Vellanki P, Rasouli N, Baldwin D, Alexanian S, Anzola I, Urrutia M, Cardona S, Peng L, Pasquel FJ, Umpierrez GE, Linagliptin Inpatient Research Group
Abstract
AIMS: 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.
MATERIALS AND METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
PMID: 30456796 [PubMed - as supplied by publisher]