Can patients with End-Stage Renal Disease (ESRD) on hemodialysis (HD) take sitagliptin (Januvia)?

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Last updated: November 6, 2025View editorial policy

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Sitagliptin Use in ESRD Patients on Hemodialysis

Yes, patients with ESRD on hemodialysis can take sitagliptin, but the dose must be reduced to 25 mg once daily to achieve plasma concentrations similar to those in patients with normal renal function receiving 100 mg daily. 1, 2

Dose Adjustment Requirements

  • Sitagliptin requires dose reduction to 25 mg once daily in patients with severe renal insufficiency (CrCl <30 mL/min), including those with ESRD on dialysis 3, 1
  • Patients with moderate renal insufficiency (CrCl 30-50 mL/min) should receive 50 mg once daily 1
  • The standard 100 mg daily dose is only appropriate for patients with normal renal function 1

Evidence for Safety and Efficacy

  • A 54-week randomized controlled trial demonstrated that sitagliptin 25 mg daily was effective and well-tolerated in ESRD patients on dialysis, reducing HbA1c by 0.72% from baseline 2
  • An earlier study showed sitagliptin provided effective glycemic control with a mean HbA1c reduction of 0.6% at 12 weeks and 0.7% at 54 weeks in patients with moderate to severe renal insufficiency, including ESRD patients on dialysis 1
  • The incidence of hypoglycemia was significantly lower with sitagliptin (6.3%) compared to glipizide (10.8%), with severe hypoglycemia occurring in 0% versus 7.7% respectively 2

Safety Profile in ESRD

  • DPP-4 inhibitors sitagliptin and linagliptin have a neutral effect on heart failure risk and may be considered in diabetic patients 3
  • The overall incidence of adverse events was generally similar between sitagliptin and comparator groups in ESRD patients 1, 2
  • Drug-related and serious adverse events, as well as discontinuations due to adverse events, were comparable between treatment groups 1
  • Higher incidences of cellulitis and headache were observed with sitagliptin compared to glipizide in one trial 2

Important Clinical Caveats

  • One case report documented rhabdomyolysis and acute renal failure when high-dose sitagliptin was combined with simvastatin in a patient with chronic renal insufficiency, suggesting caution with statin co-administration 4
  • Given the high mortality risk in ESRD populations, careful patient selection and monitoring remain essential 1
  • Saxagliptin (another DPP-4 inhibitor) is not recommended in patients with high risk of heart failure, but this does not apply to sitagliptin or linagliptin 3

Practical Implementation

  • Verify the patient's renal function and dialysis status before prescribing 1
  • Prescribe 25 mg once daily for ESRD patients on hemodialysis 1, 2
  • Monitor for hypoglycemia, though the risk is lower than with sulfonylureas 2
  • Exercise caution when co-prescribing with statins, particularly at higher doses 4
  • Continue monitoring glycemic control with HbA1c measurements, recognizing that HbA1c accuracy may be affected in ESRD 3

References

Research

Efficacy and safety of sitagliptin in patients with type 2 diabetes and ESRD receiving dialysis: a 54-week randomized trial.

American journal of kidney diseases : the official journal of the National Kidney Foundation, 2013

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Renal failure and rhabdomyolysis associated with sitagliptin and simvastatin use.

Diabetic medicine : a journal of the British Diabetic Association, 2008

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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