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About STEGLATRO® (ertugliflozin)

Updated on 01/05/2019

DIABETES

What is STEGLATRO?1

STEGLATRO is the new sodium-glucose contransporter-2 (SGLT-2) inhibitor available from MSD.

Therapeutic indications

STEGLATRO (ertugliflozin) 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.

(For study results with respect to combinations and effects on glycaemic control see sections 4.4, 4.5, and 5.1. of the Summary of Product Characteristics).

How does STEGLATRO work?

Mechanism of action1

Prescribing Information

Length: 03:34

SGLT-2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. STEGLATRO is a selective and reversible inhibitor of SGLT-2. By inhibiting SGLT-2, STEGLATRO reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

STEGLATRO has been evaluated in several Phase 3 studies involving patients with T2DM

Add-on to
Diet and Exercise
VERTIS MONO2
ERTU Monotherapy
N=461
View study
Add-on
to MET
VERTIS MET4
ERTU added to MET
N=621
View study
VERTIS SU3
ERTU vs. Glimepiride
N=1,326
Add-on to
Dual Combination
VERTIS SITA25
ERTU vs. Placebo
N=463
View study
Special
Population
VERTIS CV*6
CV Outcomes Trial
N=~8,000
VERTIS RENAL7
ERTU vs. Placebo
N=468
VERTIS ASIA8
ERTU added to MET
N=495

* Ongoing, estimated completion 2019
CV = Cardiovascular; ERTU = Ertugliflozin; MET = Metformin; MONO = Monotherapy; SITA = Sitagliptin; SU = Sulfonylurea.

VERTIS MONO Study design2
VERTIS MET Study design4
VERTIS SITA2 Study design5

References

  1. STEGLATRO Summary of Product Characteristics.
  2. Terra SG et al. Diabetes Obes Metab. 2017;19:721–728.
  3. Hollander et al. Diabetes Ther (2018) 9:193–207
  4. Rosenstock J et al. Diabetes Obes Metab. 2017;1–10.
  5. Dagogo-Jack S, et al. Diabetes Obes Metab 2018;20:530–540
  6. Cannon CP et al. Am Heart J. 2018 Dec;206:11-23.
  7. Grunberger G. et al. Diabetes Ther (2018) 9:49–66.
  8. Ji L et al. Diabetes Obes Metab. 2019;1–9
  9. Ramlo-Halsted BA et al. Prim Care. 199;26:771–789.

Supporting documentation

STEGLATRO® (ertugliflozin) 5 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

STEGLATRO® (ertugliflozin) 15 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

JANUVIA® (sitagliptin) 100 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

JANUVIA® (sitagliptin) 50 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

JANUVIA® (sitagliptin) 25 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

GB-STE-00130 | Date of Preparation: May 2019