Linagliptin

(Tradjenta®)

Tradjenta®

Drug updated on 12/11/2024

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

Indication

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

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Summary
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  • This summary is based on the review of 14 systematic review(s)/meta-analysis(es). [1-14]
  • Glycemic Control: Linagliptin effectively reduced hemoglobin A1c (HbA1c) in adults with type 2 diabetes without cardiovascular disease and in children and adolescents with type 2 diabetes. Evogliptin showed non-inferior HbA1c reductions compared to linagliptin, and combination therapy with empagliflozin and linagliptin yielded greater HbA1c reduction than either monotherapy.
  • Cardiovascular Outcomes: Linagliptin demonstrated cardiovascular safety across multiple studies, showing no increase in the risk of major adverse cardiovascular events.
  • Kidney Outcomes: Linagliptin did not significantly reduce the risk of composite kidney outcomes.
  • Comparative Effectiveness: Linagliptin was non-inferior to other dipeptidyl peptidase 4 (DPP-4) inhibitors, including evogliptin and sitagliptin, for HbA1c reduction and cardiovascular safety, with saxagliptin as an exception due to an increased risk of heart failure.
  • Common adverse events for linagliptin included nasopharyngitis, upper respiratory tract infection, and hypoglycemia, with an overall incidence similar to placebo.
  • Serious adverse events occurred in 4.0% of linagliptin patients compared to 5.2% in the placebo group.
  • Linagliptin was associated with an increased risk of bullous pemphigoid but showed no increased risk of pancreatitis or pancreatic cancer.
  • Linagliptin effectively reduced HbA1c in children and adolescents with type 2 diabetes and demonstrated consistent safety and tolerability in East Asian populations, with no significant differences in adverse events compared to placebo.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparison of gliclazide vs linagliptin on hypoglycemia and cardiovascular events in type 2 diabetes mellitus: A systematic review2022 World Journal of Diabetes
The efficacy and safety of evogliptin for type 2 diabetes mellitus: A systematic review and meta-analysis2022 Frontiers in Endocrinology
Comparative efficacy and safety of glucose-lowering drugs in children and adolescents with type 2 diabetes: A systematic review and network meta-analysis2022 Frontiers 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 trials2022 Expert Opinion on Drug Safety
Effects of Anti-Diabetic Drugs on Fracture Risk: A Systematic Review and Network Meta-Analysis2021 Frontiers in Endocrinology
Cardiovascular events and all-cause mortality in patients with type 2 diabetes treated with dipeptidyl peptidase-4 inhibitors: An extensive meta-analysis of randomized controlled trials2021 Nutrition
Effects of anti-diabetes medications on cardiovascular and kidney outcomes in Asian patients with type 2 diabetes: a rapid evidence assessment and narrative synthesis2021 Expert Opinion on Drug Safety
Microvascular Benefits of New Antidiabetic Agents: A Systematic Review and Network Meta-Analysis of Kidney Outcomes2021 The Journal of Clinical Endocrinology and Metabolism
Dipeptidyl peptidase-4 inhibitor treatment and the risk of bullous pemphigoid and skin-related adverse events: A systematic review and meta-analysis of randomized controlled trials2021 Diabetes/Metabolism Research and Reviews
The Effect of Dipeptidyl Peptidase-4 Inhibitors on Macrovascular and Microvascular Complications of Diabetes Mellitus: A Systematic Review2020 Current Therapeutic Research
Safety and tolerability of empagliflozin and linagliptin combination therapy in patients with type 2 diabetes mellitus: a pooled analysis of data from five randomized, controlled clinical trials2020 Expert Opinion on Drug Safety
Fixed-dose combination of empagliflozin and linagliptin for the treatment of patients with type 2 diabetes mellitus: A systematic review and meta-analysis2020 Diabetes
Risk of cancer in patients treated with dipeptidyl peptidase-4 inhibitors: an extensive meta-analysis of randomized controlled trials2020 Acta Diabetologica
Pancreatitis and pancreatic cancer in patientes treated with Dipeptidyl Peptidase-4 inhibitors: An extensive and updated meta-analysis of randomized controlled trials2020 Diabetes Research and Clinical Practice

Clinical Practice Guidelines