Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 5 mg) |
Drug Class | Dipeptidyl 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
- 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 Title | Year | Source |
---|---|---|
Tradjenta (linagliptin) Prescribing Information. | 2023 | Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT |