Drug updated on 6/10/2024

Dosage FormTablet (oral; 5 mg)
Drug ClassDipeptidyl peptidase-4 inhibitors
Ongoing and
Completed Studies


  • Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

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  • Linagliptin (Tradjenta) is recommended alongside diet and exercise for improving glycemic control in adults with type 2 diabetes mellitus.
  • The information comes from an analysis of 13 systematic reviews/meta-analyses concerning the efficacy and safety profile of linagliptin, especially in comparison with other glucose-lowering drugs.
  • In children and adolescents, linagliptin significantly lowers HbA1c levels, but it is less effective than saxagliptin+metformin, liraglutide+metformin, and liraglutide alone.
  • Used in combination with empagliflozin, linagliptin achieves better results in reducing HbA1c and fasting plasma glucose than when either drug is used alone.
  • Linagliptin has proven effective among Asian patients with type 2 diabetes, including those in the East Asian subgroup, indicating its global applicability in adult populations.
  • Although demonstrating a low risk for adverse events among Asian patients with type 2 diabetes, and overall tolerance being good, there is an association between DPP4 inhibitors like linagliptin and an increased risk of developing bullous pemphigoid, which requires cautious use.
  • Cardiovascular safety outcomes are favorable, without any associated increase in overall cancer risks, even suggesting a possible beneficial effect on reducing the risk of colorectal cancer, but further research is needed to compare linagliptin with gliclazide regarding major adverse cardiovascular events and hypoglycemia risks among adult type 2 diabetes patients without a history of cardiovascular disease.
  • Linagliptin may have a positive impact on endothelial function and arterial wall properties, with an observed neutral effect towards macrovascular complications, not affecting microvascular complications, except for possibly slowing the progression of albuminuria; additional trials are necessary to confirm these potential benefits.

Product Monograph / Prescribing Information

Document TitleYearSource
Tradjenta (linagliptin) Prescribing Information.2023Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparative efficacy and safety of glucose-lowering drugs in children and adolescents with type 2 diabetes: A systematic review and network meta-analysis.2022Frontiers in Endocrinology
Safety and tolerability of linagliptin in Asians with type 2 diabetes: A pooled analysis of 4457 patients from 21 randomized, double-blind, placebo-controlled clinical trials.2022Expert Opinion on Drug Safety
Comparison of gliclazide vs linagliptin on hypoglycemia and cardiovascular events in type 2 diabetes mellitus: A systematic review.2022World Journal of Diabetes
Bullous pemphigoid and dipeptidyl peptidase-4 inhibitors: A meta-analysis of randomized controlled trials.2020Endocrine
Fixed-dose combination of empagliflozin and linagliptin for the treatment of patients with type 2 diabetes mellitus: A systematic review and meta-analysis.2020Diabetes Obesity and Metabolism
Risk of cancer in patients treated with dipeptidyl peptidase-4 inhibitors: An extensive meta-analysis of randomized controlled trials.2020Acta Diabetologica
The effect of dipeptidyl peptidase-4 inhibitors on macrovascular and microvascular complications of diabetes mellitus: A systematic review.2020Current Therapeutic Research
The effect of DPP-4i on endothelial function and arterial stiffness in patients with type 2 diabetes: A systematic review of randomized placebo-controlled trials.2020Current Pharmaceutical Design
Association between medication use and bullous pemphigoid. A systematic review and meta-analysis.2020JAMA Dermatology
Dipeptidyl peptidase-4 inhibitors and bullous pemphigoid: A systematic review and adjusted meta-analysis.2020Australasian Journal of Dermatology
Effects of sodium-glucose cotransporter 2 inhibitor monotherapy on weight changes in patients with type 2 diabetes mellitus: A Bayesian network meta-analysis.2019Clinical Therapeutics
Risk of fractures associated with dipeptidyl peptidase-4 inhibitor treatment: A systematic review and meta-analysis of randomized controlled trials.2019Diabetes Therapy
The efficacy and safety of dipeptidyl peptidase-4 inhibitors for type 2 diabetes: A Bayesian network meta-analysis of 58 randomized controlled trials.2019Acta Diabetologica

Clinical Practice Guidelines