A Study to Evaluate the Efficacy and Safety of Ertugliflozin in Asian Participants With Type 2 Diabetes and Inadequate Glycemic Control on Metformin Monotherapy (MK-8835-012)

PHASE3CompletedINTERVENTIONAL
Enrollment

506

Participants

Timeline

Start Date

December 16, 2015

Primary Completion Date

December 27, 2017

Study Completion Date

December 27, 2017

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Ertugliflozin 5 mg

Ertugliflozin 5 mg oral tablet taken once daily

DRUG

Ertugliflozin 15 mg

Ertugliflozin 15 mg (5-mg and 10-mg tablets) oral taken once daily

DRUG

Placebo matching ertugliflozin

Placebo matching ertugliflozin (5-mg and/or 10-mg tablet) oral taken once daily

DRUG

Metformin

Participants are to remain on their stable doses of metformin (oral, \>=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period. Participants on metformin \<1500 at screening are up-titrated to \>= 1500 daily.

DRUG

Glimepiride

Glycemic rescue therapy with open-label glimepiride will be initiated in participants with glucose values exceeding protocol-specified values. Dosing and titration of open-label glimepiride rescue therapy will be at the Investigator's discretion.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02630706 - A Study to Evaluate the Efficacy and Safety of Ertugliflozin in Asian Participants With Type 2 Diabetes and Inadequate Glycemic Control on Metformin Monotherapy (MK-8835-012) | Biotech Hunter | Biotech Hunter