What is the use of Onglyza (Saxagliptin)?

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Last updated: April 22, 2025 • View editorial policy

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From the Guidelines

Onglyza (saxagliptin) should be used with caution in patients with type 2 diabetes, particularly those with kidney problems or at risk for heart failure, due to its potential to increase the risk of heart failure hospitalization, as noted in the 2019 study by the American Heart Association and the Heart Failure Society of America 1.

Key Considerations

  • Onglyza belongs to a class of drugs called DPP-4 inhibitors, which work by increasing incretin hormones that stimulate insulin release after meals.
  • The standard dose is 2.5 mg or 5 mg taken once daily, with or without food, but patients with kidney problems typically require the lower 2.5 mg dose.
  • Common side effects include upper respiratory infections, urinary tract infections, and headache, while more serious but rare side effects include pancreatitis, joint pain, and heart failure risk.

Clinical Evidence

  • A 2019 study published in the journal Circulation found that saxagliptin has been associated with an increased risk of heart failure hospitalization, particularly in patients with preexisting heart failure or renal impairment 1.
  • The 2018 consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) noted that DPP-4 inhibitors, including saxagliptin, have a moderate glucose-lowering efficacy and are well tolerated, but may increase the risk of hypoglycemia when used with sulfonylurea therapy 1.
  • The 2022 consensus report by the American Diabetes Association (ADA) and Kidney Disease: Improving Global Outcomes (KDIGO) recommended dose adjustments for saxagliptin in patients with chronic kidney disease, with a maximum dose of 2.5 mg daily in patients with an eGFR of 15-29 mL/min/1.73 m2 1.

Recommendations

  • Onglyza should be used with caution in patients with type 2 diabetes, particularly those with kidney problems or at risk for heart failure, and with careful monitoring for signs and symptoms of heart failure.
  • Patients with kidney problems should have their dose adjusted according to the instructions accompanying the medication, with a maximum dose of 2.5 mg daily in patients with an eGFR of 15-29 mL/min/1.73 m2.
  • Onglyza should not be used for type 1 diabetes or diabetic ketoacidosis.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Onglyza Overview

  • Onglyza, also known as saxagliptin, is a dipeptidyl peptidase 4 inhibitor used for the treatment of type 2 diabetes mellitus 2, 3, 4, 5, 6
  • It is indicated as combination therapy with metformin, a sulfonylurea, a thiazolidinedione, or insulin for the treatment of adult patients with type 2 diabetes, including those with mild to severe renal impairment 2

Efficacy and Tolerability

  • Saxagliptin has been shown to improve glycaemic control and is generally well tolerated in patients with type 2 diabetes 2, 3, 4, 5, 6
  • The clinical efficacy of saxagliptin 5 mg/day in combination with metformin, glibenclamide, a thiazolidinedione, or insulin has been demonstrated in several randomized, double-blind, placebo-controlled trials 2
  • Saxagliptin did not increase the risk of hypoglycaemia or cardiovascular outcomes relative to placebo or active comparators, and was generally weight neutral 2, 3, 4, 6

Dosage and Administration

  • Saxagliptin is administered as a 5 mg tablet once daily 2, 5
  • For patients with renal impairment, the dosage of saxagliptin may need to be adjusted, with a recommended dose of 2.5 mg once daily 2

Comparison with Other Treatments

  • Saxagliptin has been compared to other treatments, such as glipizide and sitagliptin, and has been shown to be noninferior in terms of lowering HbA(1c) 2
  • Saxagliptin has also been shown to be effective as add-on therapy to metformin, sulfonylurea, or thiazolidinedione in patients with type 2 diabetes who require combination therapy 2, 3, 4, 6

References

1
Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

4
Research

Saxagliptin for type 2 diabetes.

Diabetes, metabolic syndrome and obesity : targets and therapy, 2010

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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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