Ertugliflozin and Sitagliptin Co-administration Factorial Study (VERTIS FACTORAL, MK-8835-005)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,233

Participants

Timeline

Start Date

April 22, 2014

Primary Completion Date

May 26, 2016

Study Completion Date

May 26, 2016

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Matching Placebo to Ertugliflozin 5 mg

Placebo to ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

DRUG

Matching Placebo to Ertugliflozin 10 mg

Placebo to ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

DRUG

Matching Placebo to sitagliptin 100 mg

Placebo to sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

DRUG

Ertugliflozin 5 mg

Ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

DRUG

Ertugliflozin 10 mg

Ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

DRUG

Sitagliptin 100 mg

Sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period

DRUG

Metformin >= 1500 mg/day

Metformin \>= 1500 mg/day, tablets, oral, for 52 weeks while receiving blinded investigational product during the double-blind treatment period

BIOLOGICAL

Insulin Glargine Rescue Medication

Open-label insulin glargine, subcutaneous injection, as required as a rescue medication; dose determined per the investigator's discretion

DRUG

Glimepiride Rescue Medication

Open-label glimepiride tablets, oral, as required as a rescue medication, dose determined per the investigator's discretion

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02099110 - Ertugliflozin and Sitagliptin Co-administration Factorial Study (VERTIS FACTORAL, MK-8835-005) | Biotech Hunter | Biotech Hunter