Steglatro

Authorised

This medicine is authorised for use in the European Union

ertugliflozin

Overview

Steglatro is a medicine used to treat adults with type 2 diabetes together with diet and exercise.

Steglatro can be used in combination with other diabetes medicines or on its own in patients who cannot take metformin.

Steglatro contains the active substance ertugliflozin.

How is Steglatro used?

Steglatro is available as tablets. The dose depends on how well the patient’s glucose (sugar) levels are controlled.

The doctor will check how well the patient’s kidneys are working before treatment and regularly during treatment. The dose of Steglatro may be reduced or it may be stopped if the kidneys are not working well enough. Treatment will not be started if the kidney function is too poor.

For more information about using Steglatro, see the package leaflet or contact your doctor or pharmacist. Steglatro can only be obtained with a prescription.

How does Steglatro work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The result is a high level of glucose in the blood.

The active substance in Steglatro, ertugliflozin, helps to lower glucose in the blood by making the patient pass out glucose in the urine. It does this by blocking a protein in the kidneys (called SGLT2) that normally takes glucose back into the blood from the kidneys

What benefits of Steglatro have been shown in studies?

Seven main studies in around 4,800 patients with type 2 diabetes have shown that ertugliflozin helps lower glucose levels on its own and in combination with other diabetes medicine. The studies looked mainly at effects on levels of HbA1c (a measure of blood glucose) after six months or one year of treatment. At the start of the studies, patients’ HbA1c level was above 7 percentage points. The results were as follows:

• A study of ertugliflozin on its own, showed that levels of HbA1c fell by between 0.8 points and 1 point in patients who took the medicine compared with a rise of 0.2 points in patients receiving placebo (a dummy treatment).
• A second study found that in patients taking a combination of ertugliflozin and metformin, HbA1c levels fell by around 0.8 points, compared with a reduction of 0.03 points when placebo was added to metformin.
• A third study found that a combination of ertugliflozin at a 15 mg dose with metformin was about as effective as a combination of metformin with another diabetes medicine, glimepiride. HbA1c levels fell by 0.6 points with ertugliflozin and 0.7 points with glimepiride. A lower dose of ertugliflozin 5 mg was less effective.
• A fourth study found that, in patients taking metformin, adding ertugliflozin was as effective as adding sitagliptin (another diabetes medicine), with HbA1c levels falling by around 1 point with both treatments. HbA1c levels fell by a further 0.5 points when both medicines were added to metformin.
• A fifth study found that adding ertugliflozin to a combination of sitagliptin and metformin was more effective than placebo. HbA1c levels fell by between 0.8 and 0.9 points when ertugliflozin was added, compared with a fall of 0.1 with placebo.
• A sixth study found that adding the combination of ertugliflozin and sitagliptin to diet and exercise was much more effective than placebo, with HbA1c levels falling by between 1.6 and 1.7 points with the combination of ertugliflozin and sitagliptin compared with a fall of 0.4 points with placebo.
• A seventh study showed that ertugliflozin was not more effective than placebo in patients with moderate kidney impairment. The data from this study showed that the effect of ertugliflozin reduces when the kidneys do not work properly.

In addition to lowering glucose levels, studies showed that ertugliflozin helped reduce patients’ bodyweight and risk of heart failure.

What are the risks associated with Steglatro?

The most common side effects with Steglatro (which may affect more than 1 in 10 people) are fungal infections of the vagina and other infections of the female reproductive system and urinary tract infections.

For the full list of side effects and restrictions with Steglatro, see the package leaflet.

Why is Steglatro authorised in the EU?

The European Medicines Agency concluded that Steglatro‘s benefits are greater than its risks and it can be authorised for use in the EU.

The Agency considered that Steglatro can treat patients with type 2 diabetes on its own and in combination with other diabetes medicines. In addition, Steglatro can help some patients lose weight and may reduce the risk of heart failure. Because ertugliflozin has less effect on blood sugar in patients whose kidney function is reduced, combining Steglatro with other medicines that lower blood sugar may need to be considered in such patients.

What measures are being taken to ensure the safe and effective use of Steglatro?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Steglatro have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Steglatro is continuously monitored. Side effects reported with Steglatro are carefully evaluated and any necessary action taken to protect patients.

Other information about Steglatro

Steglatro received a marketing authorisation valid throughout the EU on 21 March 2018.

Steglatro : EPAR - Medicine overview

Reference Number: EMA/90284/2018

Steglatro : EPAR - Risk management plan summary

Product information

Steglatro : EPAR - Product Information

Steglatro : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Steglatro
• Active substance:
  ertugliflozin l-pyroglutamic acid
• International non-proprietary name (INN) or common name:
  ertugliflozin
• Therapeutic area (MeSH):
  Diabetes Mellitus, Type 2
• Anatomical therapeutic chemical (ATC) code:
  A10BK04

Pharmacotherapeutic group

• Drugs used in diabetes
• Sodium-glucose co-transporter 2 (SGLT2) inhibitors

Therapeutic indication

Steglatro is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:

• 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.

Authorisation details

• EMA product number:
  EMEA/H/C/004315
• Marketing authorisation holder:
  Merck Sharp & Dohme B.V.

  Waarderweg 39; 2031 BN Haarlem; The Netherlands

• Opinion adopted:
  25/01/2018
• Marketing authorisation issued:
  21/03/2018
• Revision:
  9

Assessment history

Changes since initial authorisation of medicine

Steglatro : EPAR - Procedural steps taken and scientific information after authorisation

Steglatro-H-C-WS1953 : EPAR - Assessment report - Variation

Adopted Reference Number: EMA/612874/2021

CHMP post-authorisation summary of positive opinion for Steglatro (WS-1953)

Adopted Reference Number: EMA/CHMP/513781/2021 Corr.

Steglatro-H-C-PSUSA-00010682-201806 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Adopted Reference Number: EMA/250417/2019

Initial marketing authorisation documents

Steglatro : EPAR - Public assessment report

Adopted Reference Number: EMA/86938/2018