Safety and Efficacy of Ertugliflozin in the Treatment of Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin (MK-8835-006; VERTIS SITA2)

PHASE3CompletedINTERVENTIONAL
Enrollment

464

Participants

Timeline

Start Date

March 12, 2014

Primary Completion Date

June 6, 2016

Study Completion Date

June 6, 2016

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Ertugliflozin 5 mg

Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks

DRUG

Ertugliflozin 15 mg

Ertugliflozin, oral, 5 mg and 10 mg tablet once daily for 52 weeks

DRUG

Placebo for ertugliflozin 5 mg

Matching placebo for ertugliflozin 5 mg, oral, once daily for 52 weeks

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.

DRUG

Sitagliptin

Participants are to remain on their stable doses of sitagliptin (oral, 100 mg once daily) while receiving blinded investigational product during the double-blind treatment period.

DRUG

Glimepiride

Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator's discretion

BIOLOGICAL

Insulin

Insulin glargine rescue medication, injectable, as required. In the event that an investigator considers use of glimepiride to not be appropriate for a participant meeting protocol specified glycemic rescue criteria, insulin glargine can be initiated as the rescue medication, and managed by the investigator according to clinical practice guidelines of the local country.

DRUG

Placebo for ertugliflozin 10 mg

Matching placebo for ertugliflozin 10 mg, oral, once daily for 52 weeks

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02036515 - Safety and Efficacy of Ertugliflozin in the Treatment of Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin (MK-8835-006; VERTIS SITA2) | Biotech Hunter | Biotech Hunter