Sitagliptin

(Januvia®)

Sitagliptin

Drug updated on 4/17/2024

Dosage FormTablet (oral; 100 mg, 50 mg, 25 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.

Summary
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  • Sitagliptin (Januvia) is indicated as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes mellitus, showing efficacy particularly when combined with insulin in patients with latent autoimmune diabetes in adults (LADA), resulting in better glycemic control, improved islet β-cell function, fewer adverse events, and a lower incidence of hypoglycemia.
  • The information was derived from 11 systematic reviews/meta-analyses focusing on the safety, efficacy, and comparison of sitagliptin with other anti-hyperglycemic agents.
  • In obese/overweight type 2 diabetic patients aiming for pronounced weight loss and glycemic control, semaglutide might be a more effective option than sitagliptin; however, it may lead to an increased pulse rate along with a higher risk of total adverse events and treatment discontinuation.
  • A network meta-analysis showed that sitagliptin had comparable rates of adverse events to placebo but highlighted gastrointestinal issues specifically associated with semaglutide use.
  • When added to metformin therapy among uncontrolled diabetics previously using only metformin, sitagliptin demonstrated significant improvements, indicating its effectiveness as part of combination therapy.
  • Data regarding the safety and efficacy of sitagliptin's usage post-kidney transplantation are currently limited, making it unclear if this drug can be confidently recommended for new-onset diabetes after transplantation, necessitating further research into this area.
  • Among DPP4 inhibitors, including vildagliptin and linagliptin, which were found efficacious at reducing HbA1C levels and fasting plasma glucose (FPG), no notable difference was observed between them or against sitagliptin concerning risks related to hypoglycemia or upper respiratory tract infections.
  • Special populations such as LADA patients could benefit from combining sitagliptin with insulin; however, more research is needed to understand its role in managing diabetes post-kidney transplantation due to currently insufficient evidence.

Product Monograph / Prescribing Information

Document TitleYearSource
Januvia (sitagliptin) Prescribing Information.2023Merck & Co. Inc., Rahway, NJ, USA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of sitagliptin and insulin for latent autoimmune diabetes in adults: a systematic review and meta-analysis.2023Journal of Diabetes Investigation Open
Comparative efficacy and safety profile of once-weekly Semaglutide versus once-daily Sitagliptin as an add-on to metformin in patients with type 2 diabetes: a systematic review and meta-analysis.2023Annals of Medicine
Semaglutide for the treatment of type 2 Diabetes Mellitus: a systematic review and network meta-analysis of safety and efficacy outcomes.2022Diabetes & Metabolic Syndrome
Efficacy and safety of sitagliptin and insulin for latent autoimmune diabetes in adults: a systematic review and meta-analysis.2022Journal of Diabetes Investigation
Comparative efficacy of dual and single initiation of add-on oral antihyperglycemic agents in type 2 diabetes uncontrolled on metformin alone: a systematic literature review and network meta-analysis.2021Diabetes Therapy
Efficacy and safety of the glucagon-like peptide-1 receptor agonist oral semaglutide in patients with type 2 diabetes mellitus: a systematic review and meta-analysis.2021Diabetes Research and Clinical Practice
Efficacy and safety of the novel dipeptidyl peptidase-4 inhibitor gemigliptin in the management of type 2 diabetes: a meta-analysis.2021Endocrinology and Metabolism
Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients.2020Cochrane Database of Systematic Reviews
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
Efficacy and safety of sitagliptin added to treatment of patients with type 2 diabetes inadequately controlled with premixed insulin.2019Diabetes, Obesity & Metabolism
Efficacy and hypoglycemic risk of sitagliptin in obese/overweight patients with type 2 diabetes compared with GLP-1 receptor agonists: a meta-analysis.2019Medicine Open

Clinical Practice Guidelines