Study: NCT02033889

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ertugliflozin 5 mg
Description: Ertugliflozin 5 mg orally (1 ertugliflozin 5 mg tablet and 1 placebo ertugliflozin 10 mg tablet), once daily from Day 1 to Week 104.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ertugliflozin 15 mg
Description: Ertugliflozin 15 mg orally (1 ertugliflozin 5 mg tablet and 1 ertugliflozin 10 mg tablet), once daily from Day 1 to Week 104.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo to Ertugliflozin
Description: Placebo to ertuglioflozin (1 placebo ertugliflozin 5 mg tablet and/or 1 placebo ertugliflozin 10 mg tablet), orally once daily from Day 1 to Week 104.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo to Ertugliflozin
Description: Placebo to ertuglioflozin (1 placebo ertugliflozin 5 mg tablet and/or 1 placebo ertugliflozin 10 mg tablet), orally once daily from Day 1 to Week 104.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Glimepiride
Description: Open-label Glimepiride will be used for glycemic rescue therapy (up to a maximum of 6 or 8 mg per day, based on the local label of glimepiride) in the 26-week initial period. Blinded Glimepiride (up to a maximum of 6 or 8 mg per day, based on the local label of glimepiride will be used in the 78-week extension period in participants who were not rescued with open-label glimepiride during the 26-week initial period.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Glimepiride
Description: Open-label Glimepiride will be used for glycemic rescue therapy (up to a maximum of 6 or 8 mg per day, based on the local label of glimepiride) in the 26-week initial period. Blinded Glimepiride (up to a maximum of 6 or 8 mg per day, based on the local label of glimepiride will be used in the 78-week extension period in participants who were not rescued with open-label glimepiride during the 26-week initial period.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Glimepiride
Description: Open-label Glimepiride will be used for glycemic rescue therapy (up to a maximum of 6 or 8 mg per day, based on the local label of glimepiride) in the 26-week initial period. Blinded Glimepiride (up to a maximum of 6 or 8 mg per day, based on the local label of glimepiride will be used in the 78-week extension period in participants who were not rescued with open-label glimepiride during the 26-week initial period.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo to Glimepiride
Description: Placebo to glimepiride will be used in the 78-week extension period in participants who were not rescued with open-label glimepiride during the 26-week initial period. Dosing and titration of placebo to glimepiride is at the discretion of the investigator.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo to Glimepiride
Description: Placebo to glimepiride will be used in the 78-week extension period in participants who were not rescued with open-label glimepiride during the 26-week initial period. Dosing and titration of placebo to glimepiride is at the discretion of the investigator.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Basal Insulin
Description: Basal insulin will be administered in the initial 26-week period for participants with glucose values exceeding protocol-specified values and for participants requiring rescue therapy in the 78-week extension period. Dosing and titration of basal insulin is at the discretion of the Investigator.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Basal Insulin
Description: Basal insulin will be administered in the initial 26-week period for participants with glucose values exceeding protocol-specified values and for participants requiring rescue therapy in the 78-week extension period. Dosing and titration of basal insulin is at the discretion of the Investigator.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Basal Insulin
Description: Basal insulin will be administered in the initial 26-week period for participants with glucose values exceeding protocol-specified values and for participants requiring rescue therapy in the 78-week extension period. Dosing and titration of basal insulin is at the discretion of the Investigator.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Metformin \>=1500 mg/day, orally, once a day