Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1233
Healthy volunteers: no

Brief summary:
This is a study of co-administration of ertugliflozin (MK-8835/PF-04971729) and sitagliptin given together or alone along with metformin in participants with Type 2 diabetes mellitus (T2DM) and inadequate glycemic control on metformin monotherapy. The primary hypothesis of this study is that ertugliflozin 15 mg daily plus sitagliptin 100 mg daily provides greater hemoglobin A1C (A1C)-lowering compared with sitagliptin 100 mg daily alone.

Detailed description:
This study will include a 1-week screening period; an up to 12-week metformin titration/dose stabilization period; a 2-week single-blind placebo run-in period; a 52-week (26-week Phase A and 26-week Phase B) double-blind treatment period and a post-treatment telephone contact 14 days after the last dose of study medication.

Arms:
arm 1: Ertugliflozin 5 mg + sitagliptin 100 mg, oral, once daily for 52 weeks arm 2: Ertugliflozin 15 mg + sitagliptin 100 mg, oral, once daily for 52 weeks arm 3: Ertugliflozin 5 mg, oral, once daily for 52 weeks arm 4: Ertugliflozin, oral, once daily for 52 weeks arm 5: Sitagliptin 100 mg, oral, once daily for 52 weeks

Interventions: intervention 1: Matching Placebo to Ertugliflozin 5 mg intervention 2: Matching Placebo to Ertugliflozin 10 mg intervention 3: Matching Placebo to sitagliptin 100 mg intervention 4: Ertugliflozin 5 mg intervention 5: Ertugliflozin 10 mg intervention 6: Sitagliptin 100 mg intervention 7: Metformin >= 1500 mg/day intervention 8: Insulin Glargine Rescue Medication intervention 9: Glimepiride Rescue Medication
Intervention descriptions: intervention 1: Placebo to ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period intervention 2: Placebo to ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period intervention 3: Placebo to sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period intervention 4: Ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period intervention 5: Ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period intervention 6: Sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period intervention 7: Metformin \>= 1500 mg/day, tablets, oral, for 52 weeks while receiving blinded investigational product during the double-blind treatment period intervention 8: Open-label insulin glargine, subcutaneous injection, as required as a rescue medication; dose determined per the investigator's discretion intervention 9: Open-label glimepiride tablets, oral, as required as a rescue medication, dose determined per the investigator's discretion

Protocol document: