Ertugliflozin

(Steglatro®)

Steglatro®

Drug updated on 12/11/2024

Dosage FormTablet (oral; 5 mg, 15 mg)
Drug ClassSodium glucose co-transporter 2 (SGLT2) 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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  • This summary is based on the review of 43 systematic review(s)/meta-analysis(es). [1-43]
  • Hemoglobin A1C (HbA1c) Reduction: Ertugliflozin showed a significant reduction in HbA1c levels compared to placebo, with a mean difference (MD) of -0.62% (95% confidence interval (CI) [-0.80, -0.44]) for 5 mg and -0.69% (95% CI [-0.91, -0.47]) for 15 mg. Reductions were comparable to other sodium-glucose cotransporter-2 (SGLT2) inhibitors.
  • Fasting Plasma Glucose (FPG): Significant reductions in FPG were observed with both 5 mg and 15 mg doses of ertugliflozin compared to placebo and other hypoglycemic agents.
  • Body Weight Reduction: Ertugliflozin significantly reduced body weight, with more pronounced effects at the 15 mg dose. Its efficacy in weight reduction was similar to other SGLT2 inhibitors.
  • Cardiovascular Outcomes: Ertugliflozin reduced hospitalizations for heart failure (hazard ratio (HR) 0.70, 95% CI 0.54-0.90) but had a borderline effect on major adverse cardiovascular events (MACEs), with slightly less efficacy compared to empagliflozin and canagliflozin.
  • Adverse Events: Ertugliflozin's adverse event profile was comparable to placebo, except for a higher incidence of genital mycotic infections, particularly in female patients, with consistent findings across doses and populations.
  • Other Safety Concerns: There were no significant differences in the risk of serious adverse events, including hypoglycemia, urinary tract infections, acute kidney injury, fractures, or cardiovascular adverse events, compared to placebo.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Steglatro (ertugliflozin) Prescribing Information.2024Merck & Co., Inc., Rahway, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and Safety of Ertugliflozin Compared to Placebo in Patients With Type 2 Diabetes: An Updated Systematic Review and Meta-Analysis2024Journal of Diabetes Research
Examining the Impact of Ertugliflozin on Cardiovascular Outcomes in Patients with Diabetes and Metabolic Syndrome: A Systematic Review of Clinical Trials2024Pharmaceuticals
Association of Sodium-Glucose Cotransporter 2 Inhibitors (SGLT2i) with Cardiac Arrhythmias: A Systematic Review and Meta-Analysis of Cardiovascular Outcome Trials2023Reviews in Cardiovascular Medicine
A model-based meta analysis study of sodium glucose co-transporter-2 inhibitors2023CPT: Pharmacometrics & Systems Pharmacology
Effect of ertugliflozin on renal function and cardiovascular outcomes in patients with type 2 diabetes mellitus: A systematic review and meta-analysis2023Medicine
Neutral effects of SGLT2 inhibitors in acute coronary syndromes, peripheral arterial occlusive disease, or ischemic stroke: a meta-analysis of randomized controlled trials2023Cardiovascular Diabetology
The Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Improving Morbidity and Mortality of Heart Failure: A Systematic Review2023Cureus
Systematic review of sodium-glucose cotransporter 2 inhibitors: a hopeful prospect in tackling heart failure-related events2023ESC Heart Failure
Dose-dependent renoprotection efficacy of sglt2 inhibitors in type 2 diabetes: systematic review and network meta-analysis2023Acta Diabetologica
Comparative cardiovascular benefits of individual SGLT2 inhibitors in type 2 diabetes and heart failure: a systematic review and network meta-analysis of randomized controlled trials2023Frontiers in Endocrinology
Comparative safety of different recommended doses of sodium-glucose cotransporter 2 inhibitors in patients with type 2 diabetes mellitus: a systematic review and network meta-analysis of randomized clinical trials2023Frontiers in Endocrinology
Longitudinal efficacy of Ertugliflozin in type 2 diabetes mellitus: a meta-analysis of randomized controlled trials2023Expert Opinion on Pharmacotherapy
Comparative safety of different sodium-glucose transporter 2 inhibitors in patients with type 2 diabetes: a systematic review and network meta-analysis of randomized controlled trials2023Frontiers in Endocrinology
Impact of sodium-glucose co-transporter 2 inhibitors on renal outcomes in patients of diabetes mellitus: A meta-analysis of landmark renal and cardiovascular outcome trials2023Indian Journal of Pharmacology
Impact of SGLT2 inhibitors on patient outcomes: a network meta-analysis2023Cardiovascular Diabetology
Cardiovascular and renal outcomes with sodium glucose co-transporter 2 inhibitors in patients with type 2 diabetes mellitus: A system review and network meta-analysis2022Frontiers in Pharmacology
Effectiveness and safety of ertugliflozin for type 2 diabetes: A meta-analysis of data from randomized controlled trials2022Journal of Diabetes Investigation
Association of SGLT2 Inhibitors With Risk of Atrial Fibrillation and Stroke in Patients With and Without Type 2 Diabetes: A Systemic Review and Meta-Analysis of Randomized Controlled Trials2022Journal of Cardiovascular Pharmacology
Cardiovascular outcomes in patients treated with sodium-glucose transport protein 2 inhibitors, a network meta-analysis of randomized trials2022Frontiers in Cardiovascular Medicine
Relationship Between SGLT-2i and Ocular Diseases in Patients With Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials2022Frontiers in endocrinology
Renal protective effect and safety of sodium-glucose cotransporter-2 inhibitors in patients with chronic kidney disease and type 2 diabetes mellitus: a network meta-analysis and systematic review2022International Urology and Nephrology
Efficacy and Safety of Ertugliflozin in Type 2 Diabetes: A Systematic Review and Meta-Analysis2021Frontiers in Pharmacology
Comparative efficacy of sodium-glucose cotransporter-2 inhibitors (SGLT2i) for cardiovascular outcomes in type 2 diabetes: a systematic review and network meta-analysis of randomised controlled trials2021Heart Failure Reviews
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-Analysis2021Diabetes Therapy
Effect of sodium-dependent glucose transporter inhibitors on glycated hemoglobin A1c after 24 weeks in patients with diabetes mellitus: A systematic review and meta-analysis2021Medicine
Association of SGLT2 inhibitors with arrhythmias and sudden cardiac death in patients with type 2 diabetes or heart failure: A meta-analysis of 34 randomized controlled trials2021Heart Rhythm
Meta-Analysis of Noncompartmental Pharmacokinetic Parameters of Ertugliflozin to Evaluate Dose Proportionality and UGT1A9 Polymorphism Effect on Exposure2021Journal of Clinical Pharmacology
Safety of four SGLT2 inhibitors in three chronic diseases: A meta-analysis of large randomized trials of SGLT2 inhibitors2021Diabetes & Vascular Disease Research
Comparison of New Oral Hypoglycemic Agents on Risk of Urinary Tract and Genital Infections in Type 2 Diabetes: A Network Meta-analysis2021Advances in Therapy
Comparative efficacy of glucose-lowering medications on body weight and blood pressure in patients with type 2 diabetes: A systematic review and network meta-analysis2021Diabetes, Obesity & Metabolism
The effects of sodium glucose co-transporter (SGLT) 2 inhibitors on hematocrit levels: a systematic review and meta-analysis of randomized controlled trials2021Annals of Palliative Medicine
SGLT-2i and Risk of Malignancy in Type 2 Diabetes: A Meta-Analysis of Randomized Controlled Trials2021Frontiers in Public Health
Anti-diabetic drugs and weight loss in patients with type 2 diabetes2021Pharmacological Research
Comparative efficacy of 5 sodium glucose cotransporter 2 inhibitor and 7 glucagon-like peptide 1 receptor agonists interventions on cardiorenal outcomes in type 2 diabetes patients: A network meta-analysis based on cardiovascular or renal outcome trials2021Medicine
Sodium-Glucose Cotransporter 2 Inhibitors, All-Cause Mortality, and Cardiovascular Outcomes in Adults with Type 2 Diabetes: A Bayesian Meta-Analysis and Meta-Regression2021Journal of the American Heart Association
Gliflozins for the prevention of stroke in diabetes and cardiorenal diseases: A meta-analysis of cardiovascular outcome trials2021Medicine
SGLT-2 inhibitors and cardiorenal outcomes in patients with or without type 2 diabetes: a meta-analysis of 11 CVOTs2021Cardiovascular Diabetology
Safety of Ertugliflozin in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Conventional Therapy at Different Periods: A Meta-Analysis of Randomized Controlled Trials2020Journal of Diabetes Research
Effect of ertugliflozin on glycemic levels, blood pressure and body weight of patients with type 2 diabetes mellitus: a systematic review and meta-analysis2020Journal of Diabetes and Metabolic Disorders
Sodium-glucose co-transporter-2 inhibitors and major adverse limb events: A trial-level meta-analysis including 51 713 individuals2020Diabetes, Obesity & Metabolism
Efficacy and safety of ertugliflozin in older patients with type 2 diabetes: A pooled analysis of phase III studies2020Diabetes, Obesity & Metabolism
Association between sodium-glucose cotransporter 2 (SGLT2) inhibitors and lower extremity amputation: A systematic review and meta-analysis2020PLoS One
Efficacy and safety of ertugliflozin in East/Southeast Asian patients with type 2 diabetes mellitus2020Diabetes, Obesity & Metabolism

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