Sitagliptin

(Januvia®)

Januvia®

Drug updated on 9/4/2024

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.

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Summary
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  • Januvia (sitagliptin) 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 11 systematic review(s)/meta-analysis(es). [1-11]
  • LADA Patients (Sitagliptin + Insulin vs. Insulin Alone): Sitagliptin combined with insulin resulted in a reduction of HbA1c (WMD -0.36, 95% CI -0.61 to -0.10) and an increase in fasting C-peptide (WMD 0.08, 95% CI -0.02 to 0.17).
  • T2DM Patients (Semaglutide vs. Sitagliptin): Semaglutide, compared to sitagliptin, led to a greater reduction in HbA1c (WMD -0.98, 95% CI -1.28 to -0.69), with additional benefits in systolic and diastolic blood pressure, body weight, and waist circumference.
  • T2DM Patients (Dual vs. Single Oral AHAs): Dual therapy with ertugliflozin and sitagliptin showed greater HbA1c reduction and significant decreases in body weight and systolic blood pressure compared to single-agent DPP-4 inhibitors.
  • Overweight/Obese T2DM Patients (Sitagliptin vs. GLP-1 Receptor Agonists): Sitagliptin was less effective than GLP-1 receptor agonists in reducing HbA1c, fasting plasma glucose, and postprandial glucose.
  • In LADA patients, the combination of sitagliptin and insulin resulted in fewer adverse events and a lower incidence of hypoglycemia compared to insulin alone.
  • In T2DM patients, semaglutide was associated with a higher risk of total adverse events and treatment discontinuation compared to sitagliptin, though there were no significant differences in serious, severe, moderate, and mild adverse events.
  • Across various T2DM populations, sitagliptin showed a comparable safety profile to other treatments, with no significant increases in hypoglycemia or other severe adverse events.
  • The reviewed study contains population and subgroup information specific to LADA patients, T2DM patients on metformin, T2DM patients using premixed insulin, and overweight/obese T2DM patients.

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