Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017)

PHASE3CompletedINTERVENTIONAL
Enrollment

291

Participants

Timeline

Start Date

September 23, 2014

Primary Completion Date

February 23, 2016

Study Completion Date

February 23, 2016

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Ertugliflozin

Ertugliflozin, 5 mg or 15 mg, administered orally, once daily for 26 weeks.

DRUG

Sitagliptin

Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.

DRUG

Placebo to Ertugliflozin

Matching placebo to ertugliflozin administered orally, once daily for 26 weeks.

DRUG

Placebo to Sitagliptin

Matching placebo to sitagliptin administered orally, once daily for 26 weeks.

DRUG

Glimepiride

Open-label glimepiride rescue therapy will be initiated at 1 or 2 mg/day and may be titrated to the maximum labeled dose or maximum tolerated dose (if lower than labeled dose), as considered appropriate by the investigator, based on blood glucose measurements and in accordance with the local, approved label.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02226003 - Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017) | Biotech Hunter | Biotech Hunter