MedPath

Ertugliflozin

Generic Name
Ertugliflozin
Brand Names
Segluromet, Steglatro, Steglujan
Drug Type
Small Molecule
Chemical Formula
C22H25ClO7
CAS Number
1210344-57-2
Unique Ingredient Identifier
6C282481IP
Background

Ertugliflozin is a sodium-dependent glucose cotransporter-2 (SGLT2) inhibitor used to treat type II diabetes mellitus. It works to block glucose reabsorption from the glomerulus.

Ertugliflozin was first approved by the FDA in December 2017. It was also approved by the European Commission in March 2018.

Indication

Ertugliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus (T2DM). It is also available in combination with either metformin or sitagliptin.

Ertugliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.

Associated Conditions
Type 2 Diabetes Mellitus
Associated Therapies
-

Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009)

Phase 1
Completed
Conditions
Renal Impairment
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2013-09-24
Last Posted Date
2019-02-18
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
36
Registration Number
NCT01948986

Evaluation of Pharmacokinetics, Safety, And Tolerability Of Ertugliflozin (PF-04971729, MK-8835) In Japanese And Western Healthy Participants (MK-8835-041)

Phase 1
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Ertugliflozin
Drug: Placebo
First Posted Date
2010-10-19
Last Posted Date
2016-05-20
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
24
Registration Number
NCT01223339

A Radiolabeled Mass Balance Study of [14C]-Ertugliflozin (PF04971729, MK-8835) In Healthy Male Participants (MK-8835-038)

Phase 1
Completed
Conditions
Type 2 Diabetes Mellitus (T2DM)
Interventions
First Posted Date
2010-05-20
Last Posted Date
2016-03-23
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
6
Registration Number
NCT01127308

A Multiple Dose Study Of Ertugliflozin (PF-04971729, MK-8835) In Otherwise Healthy Overweight And Obese Volunteers (MK-8835-037)

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
First Posted Date
2009-11-25
Last Posted Date
2020-05-29
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
40
Registration Number
NCT01018823

A Single Escalating Dose Study Of Ertugliflozin (PF-04971729, MK-8835) Under Fed and Fasted Conditons In Healthy Volunteers (MK-8835-036)

Phase 1
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2009-10-02
Last Posted Date
2020-05-29
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
24
Registration Number
NCT00989079
© Copyright 2025. All Rights Reserved by MedPath