Drug updated on 11/1/2024
Dosage Form | Tablet (oral; 5 mg) |
Drug Class | Dipeptidyl 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
- This summary is based on the review of 14 systematic review(s)/meta-analysis(es). [1-14]
- Glycemic Control: Linagliptin effectively reduced HbA1c (hemoglobin A1c) 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 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 Title | Year | Source |
---|---|---|
Tradjenta (linagliptin) Prescribing Information. | 2023 | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT |