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Author Notes:

Correspondence: Guillermo E. Umpierrez, MD, 69 Jesse Hill Jr Dr. SE, Glenn Building, Suite 202, Atlanta, GA 30303, Phone: (404) 778-1663, Fax: (404) 524-3052, geumpie@emory.edu

hese collaborators contributed to the recruitment and care of study subjects and collected the data. University of Colorado, Division of Endocrinology: Hoda Bakhtiari, Cecilia Low Wang, MD and the Glucose Management Team;

Rush University, Division of Endocrinology: Jocelyn Jones; Boston University, Division of Endocrinology: Katherine Modzelewski, Elizabeth Ensminger; Emory University, Division of Endocrinology, Metabolism and Lipids: J. Sonya Haw, Maya Fayfman, Clementina Ramos, Patricia Gomez.

Disclosures: G.E.U. has received unrestricted research support for inpatient studies (to Emory University) from Merck, Novo Nordisk, AstraZeneca, Boehringer Ingelheim, and Sanofi and has received advisory/consulting fees from Sanofi and Merck. P.V. has received consulting fees from Boehringer Ingelheim and Merck.

F.J.P. has received consulting fees from Merck, Sanofi, and Boehringer Ingelheim. N.R. has received research support from Novo Nordisk, AstraZeneca, Boehringer Ingelheim, and Intarcia. The remaining authors have no others conflicts of interest.

Subjects:

Research Funding:

This was an investigator-initiated study funded by Boehringer Ingelheim and Atlanta and Colorado CTSA grants, Public Health Service Grant UL1 RR025008 and UL1 TR001082 from the Clinical and Translational Science Award program, and 1P30DK111024-01 from the National Institutes of Health and National Center for Research Resources.

PV was funded in part by K12HD085850.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Endocrinology & Metabolism
  • DPP-IV inhibitor
  • glycaemic control
  • incretin therapy
  • randomised trial
  • Critically ill
  • Glucose control
  • Hospitalized patients
  • Inpatient management
  • General medicine
  • Hyperglycemia
  • Therapy
  • Mortality
  • Sitagliptin
  • Infection

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

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Journal Title:

Diabetes Obesity & Metabolism

Volume:

Volume 21, Number 4

Publisher:

, Pages 837-843

Type of Work:

Article | Post-print: After Peer Review

Abstract:

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.

Copyright information:

© 2019 John Wiley & Sons Ltd

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