Study: NCT02036515

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ertugliflozin 15 mg
Description: Ertugliflozin, oral, 5 mg and 10 mg tablet once daily for 52 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo for ertugliflozin 5 mg
Description: Matching placebo for ertugliflozin 5 mg, oral, once daily for 52 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: 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.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Metformin
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sitagliptin
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sitagliptin
Description: 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.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Sitagliptin
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Glimepiride
Description: Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator's discretion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Glimepiride
Description: Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator's discretion

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Glimepiride
Description: Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator's discretion

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Insulin
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Insulin
Description: 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.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Insulin
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo for ertugliflozin 10 mg
Description: Matching placebo for ertugliflozin 10 mg, oral, once daily for 52 weeks