Linagliptin

(Tradjenta®)

Tradjenta®

Drug updated on 9/4/2024

Dosage FormTablet (oral; 5 mg)
Drug ClassDipeptidyl peptidase-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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  • Tradjenta (linagliptin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
  • Reduction in HbA1c: Linagliptin-5 mg significantly reduced HbA1c in children and adolescents. Combination therapy of empagliflozin + linagliptin showed greater reductions in HbA1c and fasting plasma glucose than either monotherapy. Comparatively, saxagliptin+metformin and liraglutide+metformin were more effective than linagliptin.
  • Weight Reduction: Linagliptin had a neutral effect on weight, whereas SGLT2 inhibitors, like canagliflozin, demonstrated superior weight reduction compared to linagliptin.
  • Vascular Function: Linagliptin may improve endothelial function and provide slight benefits to arterial wall properties, although no significant cardiovascular outcomes were observed.
  • Macrovascular and Microvascular Outcomes: Linagliptin did not significantly impact macrovascular or microvascular complications, but it may slow the progression of albuminuria.
  • Adverse Events: Linagliptin was well tolerated with a low risk of adverse events, including common occurrences of nasopharyngitis, upper respiratory tract infection, and hypoglycemia. A single case of pancreatitis was reported. The safety profile was consistent in both combination therapy (empagliflozin + linagliptin) and monotherapy.
  • Serious Adverse Events: Serious adverse events occurred in 4.0% of linagliptin-treated patients compared to 5.2% in placebo-treated patients. Linagliptin was associated with an increased risk of bullous pemphigoid.
  • Cancer and Fracture Risk: No increased overall cancer risk was associated with DPP-4 inhibitors, including linagliptin, and there was no effect on fracture risk compared to placebo or other antidiabetic drugs. A potential beneficial effect for colorectal cancer was suggested.
  • Linagliptin-5 mg demonstrated efficacy in reducing HbA1c in children and adolescents aged 10-17 years and was well tolerated with a low risk of adverse events in Asian patients with T2D, including East Asians. Additionally, linagliptin was evaluated for cardiovascular safety in patients with T2D with and without established cardiovascular disease, showing safety in both groups.

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

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