Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 464
Healthy volunteers: no

Brief summary:
This is a safety and efficacy study of ertugliflozin (MK-8835/PF-04971729) in the treatment of participants with type 2 diabetes mellitus who have inadequate glycemic control on metformin and sitagliptin. The primary objective of the trial is to assess the hemoglobin A1C (A1C)-lowering efficacy of the addition of ertugliflozin compared to the addition of placebo with an underlying hypothesis that addition of treatment with ertugliflozin provides greater reduction in A1C compared with the addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of ertugliflozin.

Detailed description:
The duration of the trial will be approximately 69 weeks. This will include a 1-week Screening Period, an up to 12-week wash-off/titration /dose-stabilization period, a 2-week single-blind, placebo run-in period, a 52-week double-blind, placebo-controlled treatment period (including a 26-week Phase A and 26-week Phase B), and a post-treatment telephone contact 14 days after the last dose of blinded investigational product.

Arms:
arm 1: Ertugliflozin, 5 mg, oral, once daily for 52 weeks arm 2: Ertugliflozin, 15 mg, oral, once daily for 52 weeks arm 3: Matching placebo to ertuglifozin, oral, once daily for 52 weeks

Interventions: intervention 1: Ertugliflozin 5 mg intervention 2: Ertugliflozin 15 mg intervention 3: Placebo for ertugliflozin 5 mg intervention 4: Metformin intervention 5: Sitagliptin intervention 6: Glimepiride intervention 7: Insulin intervention 8: Placebo for ertugliflozin 10 mg
Intervention descriptions: intervention 1: Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks intervention 2: Ertugliflozin, oral, 5 mg and 10 mg tablet once daily for 52 weeks intervention 3: Matching placebo for ertugliflozin 5 mg, oral, once daily for 52 weeks intervention 4: 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 5: 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 6: Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator's discretion intervention 7: 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 8: Matching placebo for ertugliflozin 10 mg, oral, once daily for 52 weeks

Protocol document: