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Glycaemic efficacy and safety of linagliptin compared to a basal‐bolus insulin regimen in patients with type 2 diabetes undergoing non‐cardiac surgery: A multicentre randomized clinical trial
Author(s) -
Vellanki Priyathama,
Rasouli Neda,
Baldwin David,
Alexanian Sara,
Anzola Isabel,
Urrutia Maria,
Cardona Saumeth,
Peng Limin,
Pasquel Francisco J.,
Umpierrez Guillermo E.
Publication year - 2019
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.13587
Subject(s) - linagliptin , medicine , type 2 diabetes , regimen , insulin , bolus (digestion) , diabetes mellitus , randomized controlled trial , clinical endpoint , prospective cohort study , randomization , surgery , gastroenterology , urology , anesthesia , endocrinology
Aims The use of incretin‐based therapy, rather than or complementary to, insulin therapy is an active area of research in hospitalized patients with type 2 diabetes (T2D). We determined the glycaemic efficacy and safety of linagliptin compared to a basal‐bolus insulin regimen in hospitalized surgical patients with T2D. Materials and Methods This prospective open‐label multicentre study randomized T2D patients undergoing non‐cardiac surgery with admission blood glucose (BG) of 7.8 to 22.2 mmol/L who were under treatment with diet, oral agents or total insulin dose (TDD) ≤ 0.5 units/kg/day to either 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 higher in the linagliptin group compared to the basal‐bolus group (9.5 ± 2.6 vs 8.8 ± 2.3 mmol/L/dL, P = 0.03) with a mean daily BG difference of 0.6 mmol/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 the linagliptin and basal‐bolus groups (8.9 ± 2.3 vs 8.7 ± 2.3 mmol/L, P = 0.43); however, patients with BG ≥ 11.1 mmol/L who were treated with linagliptin had higher BG compared to the basal‐bolus group (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), with similar supplemental insulin and fewer daily insulin injections (2.0 ± 3.3 vs 3.1 ± 3.3, P < 0.001) compared to the basal‐bolus group. Conclusions For patients with T2D undergoing non‐cardiac surgery who presented 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.