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

• Published in: Diabetes, obesity & metabolism obesity & metabolism, 2019-04, Vol.21 (4), p.837-843
• Main Authors: Vellanki, Priyathama, Rasouli, Neda, Baldwin, David, Alexanian, Sara, Anzola, Isabel, Urrutia, Maria, Cardona, Saumeth, Peng, Limin, Pasquel, Francisco J., Umpierrez, Guillermo E., Bakhtiari, Hoda, Wang, Cecilia Low, Jones, Jocelyn, Modzelewski, Katherine, Ensminger, Elizabeth, Haw, J. Sonya, Fayfman, Maya, Ramos, Clementina, Gomez, Patricia
• Format: Article
• Language: English
• Subjects: Aged; Amputation, Surgical; Blood glucose; Blood Glucose - metabolism; Clinical trials; Diabetes; Diabetes mellitus; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - metabolism; Digestive System Surgical Procedures; Dipeptidyl-Peptidase IV Inhibitors - therapeutic use; DPP‐IV inhibitor; Evidence-based medicine; Female; glycaemic control; Glycated Hemoglobin - metabolism; Gynecologic Surgical Procedures; Heart; Hospitalization; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemia - chemically induced; Hypoglycemic Agents - therapeutic use; incretin therapy; Insulin; Insulin - therapeutic use; Insulin Glargine - therapeutic use; Insulin, Short-Acting - therapeutic use; Linagliptin - therapeutic use; Male; Middle Aged; Orthopedic Procedures; Patients; Perioperative Care - methods; randomised trial; Surgical Procedures, Operative; Treatment Outcome; Urologic Surgical Procedures
• ISSN: 1462-8902; 1463-1326; 1463-1326
• DOI: 10.1111/dom.13587

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.