Information intended for UK healthcare professionals and relevant NHS decision-makers only.

This formulary decision guide was developed from content provided by MSD UK Ltd in a format developed by Guidelines in Practice.

View prescribing information and adverse events reporting

Key points

  • Ertugliflozin is indicated in adults (≥18 years of age) with type 2 diabetes mellitus, as an adjunct to diet and exercise to improve glycaemic control1
  • Ertugliflozin significantly reduced HbA1c, body weight*, and systolic blood pressure* compared with placebo and reductions were sustained over the course of the VERTIS clinical trial programme2,3
  • Switching eligible patients on other SGLT-2 inhibitors to Steglatro® could generate estimated potential annual savings of £28,802 per 100,000 people, and of £84,512 for an average CCG (see assumptions).†

* Ertugliflozin is not indicated for body weight or systolic blood pressure reduction

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Drug name

Steglatro® (Ertugliflozin)


  • Ertugliflozin is indicated in adults (≥18 years of age) with type 2 diabetes mellitus, as an adjunct to diet and exercise to improve glycaemic control:1
    • as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications
    • in addition to other medicinal products for the treatment of diabetes.


  • The recommended starting dose of ertugliflozin is 5 mg once daily—the dose can be increased to 15 mg once daily if additional glycaemic control is needed1
  • Renal impairment:1
    • do not initiate in patients with an eGFR < 60 ml/min/1.73m2 or creatinine clearance (CrCl) < 60 ml/min
    • discontinue when eGFR is persistently < 45 ml/min/1.73m2 or CrCl is persistently < 45 ml/min
  • When ertugliflozin is used in combination with insulin or an insulin secretagogue, a lower dose of insulin or of the insulin secretagogue may be required to reduce the risk of hypoglycaemia1
  • In patients with volume depletion, correcting this condition prior to initiation of ertugliflozin is recommended.1

Cardiovascular safety

  • The VERTIS-CV trial achieved its primary endpoint of non-inferiority for major adverse cardiovascular events compared with placebo in patients with type 2 diabetes mellitus and established atherosclerotic cardiovascular (CV) disease (Hazard ratio [HR]: 0.97 [95.6% CI: 0.85–1.11], p < 0.001)4
  • The key secondary endpoints were not met. Statistical significance was not reached for the secondary composite endpoint of CV death or hospitalisation for heart failure (HHF); no further testing could be performed due to the hierarchical statistical testing method employed4
  • HHF was a pre-specified secondary endpoint but did not have an associated hypothesis and was not part of the hierarchical statistical plan; a relative risk reduction of 30% was observed (absolute risk reduction = 1.1%, 2.5% pooled ertugliflozin group vs 3.6% placebo) (HR: 0.70 [95% CI: 0.54–0.90])4
  • Ertugliflozin was generally well tolerated, with a safety profile consistent with the SGLT-2 inhibitor class4
  • The incidence of adverse events, serious adverse events, and discontinuation due to adverse events was similar between ertugliflozin and placebo treatment arms, consistent with that observed across the VERTIS programme4 
  • The incidences of symptomatic hypoglycaemia, hypovolemia, pancreatitis and bone fracture were low and similar in the ertugliflozin and placebo treatment arms4
  • No adverse events of Fournier’s gangrene were reported4
  • The frequencies of urinary tract infections and genital mycotic infections were higher with ertugliflozin vs. placebo4
  • The incidence of amputations, was numerically higher with ertugliflozin vs. placebo.4

Budgetary implications

  • Ertugliflozin offers an opportunity to realise cost savings when prescribing an SGLT-2 inhibitor 
  • Ertugliflozin list price is approximately 20% lower than all other SGLT-2 inhibitors5
SGLT-2 inhibitor28 days supply5









  • In 2020, 7659 packs of SGLT-2 inhibitors were used per 100,000 people at the cost of £36.59 per pack;5,6 this represents a cost of £146,575 in patients without established cardiovascular disease (eCVD) and with estimated glomerular filtration rate (eGFR) ≥ 60 ml/min/1.73m2. Switching patients to ertugliflozin could generate estimated potential savings of £28,802 per 100,000 people and £84,512 for an average clinical commissioning group (CCG)
  • Estimate the potential savings for your CCG using this budget impact model (this link will take you to an MSD promotional website).  

 The costs were calculated using the following data:
a. annual sales of SGLT-2 inhibitors, excluding ertugliflozin (2020) = 5,146,810 in the UK
b. current costs at £36.59 per pack5
c. Steglatro® costs at £29.40 per pack5
d. type 2 diabetes mellitus population without established cardiovascular disease and estimated glomerular filtration rate (eGFR) ≥ 60 ml/min/1.73m2 = 52.3%7
e. median CCG population = 293,4238

Evidence for use

  • Ertugliflozin provides significant HbA1c reductions as well as body weight and systolic blood pressure reductions, consistent across the VERTIS clinical trial program2,3,9,10
  • Steglatro® is not licensed for body weight or blood pressure reduction.
 Placebo-adjusted LS mean reduction from baseline at week 26:
Therapy and study Dose (mg) HbA1c (%)  Body weight (Kg)  Systolic blood pressure (mmHg) 
Dual therapy
(+ metformin)
Triple therapy
(+metformin +sitagliptin)

*superiority over placebo not statistically significant

Safety profile

  • Ertugliflozin should not be used in patients with type 1 diabetes mellitus1
  • Very common reported adverse reactions are vulvovaginal mycotic infections and other female genital mycotic infections1
  • Common adverse events include: balanitis candida and other male genital mycotic infections, hypoglycaemia, volume depletion, increased urination, vulvovaginal pruritus, thirst, serum lipids changed, haemoglobin and blood urea nitorgen increase1
  • Serious diabetic ketoacidosis occurs rarely1
  • Ertugliflozin may add to the diuretic effect of diuretics and may increase the risk of dehydration and hypotension1
  • Ertugliflozin may increase the risk of hypoglycaemia when used in combination with insulin and/or an insulin secretagogue; therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with ertugliflozin1
  • Please refer to the summary of product characteristics for a full list of safety information.1


  1. Merck Sharp & Dohme Limited. Steglatro film-coated tablets—summary of product characteristics. March 2021.
  2. Pratley at al. Diabetes Obes Metab 2018; 20 (3): 1111–1120.
  3. Rosenstock J et al. Diabetes Obes Metab 2018; 20 (3): 520–529.
  4. Cannon C et al. N Engl J Med 2020; 383: 1425–1435.
  5. NHS Business Services Authority. Drug Tariff 2021. 
  6. IQVIA. Retail dispensing audit—units MAT. December 2020.
  7. Lautsch D et al. Diabetes Ther 2019; 10: 2131–2137.
  8. Office for National Statistics. Clinical commissioning group population estimates (National Statistics); Mid-2019: SAPE22DT6a. Available at:  
  9. Terra S et al. Diabetes Obes Metab 2017; 19 (5): 721–728.
  10. Dagogo-Jack S et al. Diabetes Obes Metab 2018; 20 (3): 530–540.

Adverse events should be reported. Reporting forms and information can be found at or search for MHRA Yellow Card in Google Play or Apple App Store. Adverse events should also be reported to MSD, UK (Tel: 0208 1548 000). By clicking the above link you will leave the MSD website and be taken to the MHRA website. 


Date of preparation: July 2021