A Study of the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise (MK-8835-003, VERTIS MONO)

PHASE3CompletedINTERVENTIONAL
Enrollment

461

Participants

Timeline

Start Date

October 9, 2013

Primary Completion Date

July 28, 2016

Study Completion Date

July 28, 2016

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Ertugliflozin 5 mg

One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).

DRUG

Ertugliflozin 10 mg

One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).

DRUG

Placebo to Ertugliflozin

One placebo tablet matching the ertugliflozin 5 mg tablet and/or 1 placebo tablet matching the ertugliflozin 10 mg tablet per day taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).

DRUG

Metformin

500 mg (1 tablet) in the morning and 500 mg (1 tablet) in the evening for 2 weeks, 1000 mg (2 tablets 500 mg) in the morning and 500 mg (1 tablet) in the evening for 2 weeks and 1000 mg (2 tablets 500 mg) in the morning and 1000 mg (2 tablets 500 mg) in the evening, thereafter.

DRUG

Placebo to Metformin

1 tablet in the morning and 1 tablet in the evening for 2 weeks, 2 tablets in the morning and 1 tablet in the evening for 2 weeks and 2 tablets in the morning and 2 tablets in the evening, thereafter.

DRUG

Glimepiride

Dosing and titration of glimepiride as rescue therapy was determined by the investigator.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY