Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,326

Participants

Timeline

Start Date

December 16, 2013

Primary Completion Date

April 18, 2017

Study Completion Date

April 18, 2017

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Ertugliflozin 5 mg

Ertugliflozin, 5 mg, oral, once daily, from Day 1 to Week 104

DRUG

Ertugliflozin 10 mg

Ertugliflozin, 10 mg, oral, once daily from Day 1 to Week 104.

DRUG

Glimerpiride

Glimepiride, oral tablets, initiated at 1 mg daily and titrated up to the maximum approved dose (8 mg daily based on the local country label) or maximum tolerated dose

DRUG

Placebo to Ertugliflozin

Matching placebo to ertugliflozin, 5 mg and/or 10 mg, oral, once daily, from Day 1 to Week 104

DRUG

Placebo to Glimepiride

Matching placebo to glimepiride, 1 mg or 2 mg, oral, once daily, from Day 1 to Week 104.

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

Sitagliptin

Open label, oral, once daily, rescue medication as required.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01999218 - Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002) | Biotech Hunter | Biotech Hunter