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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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.
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The use of DPP-4i with or without basal insulin may be a safer and simpler plan for people with mild to moderate hyperglycemia on admission (e.g., admission glucose <180-200 mg/dL), with reduced risk of hypoglycemia.
“The use of DPP-4i with or without basal insulin may be a safer and simpler plan for people with mild to moderate hyperglycemia on admission (e.g., admission glucose <180-200 mg/dL), with reduced risk of hypoglycemia (91,92).”
From 16. Diabetes Care in the Hospital: Standards of Care in Diabetes—2026 (2026) · cites this paper as [91]
A few randomized trials demonstrated the safety and efficacy of DPP-4i in specific groups of hospitalized people with diabetes.
“A few randomized trials demonstrated the safety and efficacy of DPP-4i in specific groups of hospitalized people with diabetes (91-93).”
From 16. Diabetes Care in the Hospital: Standards of Care in Diabetes—2026 (2026) · cites this paper as [91]
NPH may give glycemic control similar to insulin analogs, with slightly more hypoglycemia, but requires higher insulin doses and more injections per day.
“Although some RCTs have shown similar glycemic control and lower hypoglycemia with the use of insulin analogs1308 in low-resource settings, the use of NPH may result in similar glycemic control, with minimally increased hypoglycemia,1347,1348 albeit with higher insulin dose and injections per day.”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [1347]
The Results and Discussion compare linagliptin with a basal-bolus insulin regimen in non-cardiac surgical patients, not NPH with insulin analogs. Searches for NPH, neutral protamine Hagedorn, and the claimed differences in hypoglycemia, dose, and injections found no passage addressing that comparison in our copy. (LLM, conf=0.78)
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Self-citation
- Authors
- Vellanki, P., Rasouli, N., Baldwin, D., Alexanian, S., Anzola, I., Urrutia, M., Cardona, S., Peng, L., Pasquel, F. J., Umpierrez, G. E., & Linagliptin Inpatient Research Group
- Affiliations
- Emory University (US)
- University of Colorado Denver (US)
- Rush University Medical Center (US)
- Boston University (US)
- Corresponding author
- Umpierrez, Guillermo E.
- ORCID
- Venue
- Diabetes, Obesity and Metabolism
- Publisher
- Wiley
- Published
- 2018-12-17
- Volume
- 21
- Issue
- 4
- Pages
- 837-843
- ISSN
- 1462-8902 (ISSN-L)
- 1463-1326
- PMC
- PMC7231260
- OpenAlex
- W2901813837
- Cited by
- 80
- References
- 28
- Citations by year
- 2026: 4 · 2025: 8 · 2024: 13 · 2023: 13 · 2022: 12 · 2021: 10 · 2020: 15 · 2019: 5
- FWCI
- 5.97
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Diabetes Obesity and Metabolism (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Boehringer Ingelheim
- National Institutes of Health (1P30DK111024‐01)
- National Center for Research Resources (1P30DK111024‐01UL1, TR001082UL1RR025008)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- linagliptin, multiple daily insulin injections, type 2 diabetes, non-cardiac surgery, perioperative glycemic control, DPP-4 inhibitors, incretin-based therapy, hypoglycemia, blood glucose, glargine, rapid-acting insulin, insulin dose reduction, hospitalized surgical patients, insulin injection
- MeSH terms
- Insulin Glargine, Linagliptin, Aged, Amputation, Surgical, Blood Glucose, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Hospitalization, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Male, Middle Aged, Digestive System Surgical Procedures, Gynecologic Surgical Procedures, Surgical Procedures, Operative, Urologic Surgical Procedures, Treatment Outcome, Orthopedic Procedures, Perioperative Care, Dipeptidyl-Peptidase IV Inhibitors, Insulin, Short-Acting
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