Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 468
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in participants with Type 2 diabetes mellitus with Stage 3 Chronic Kidney Disease (CKD) who have inadequate glycemic control on background antihyperglycemic therapy. The duration of this trial will be up to 67 weeks. This study will consist of a 1-week Screening Period, a 10-week wash-off period from metformin, if needed, and a 2-week placebo run-in period, a 52-week double-blind treatment period, and a 14-day post-treatment follow-up period. The primary objective of this 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 to the addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of ertugliflozin.

Detailed description:
Participants who meet protocol-defined glycemic rescue criteria will be permitted to have an adjustment in the dose(s) of background antihyperglycemic agent (AHA) therapy or addition of new AHA therapy as directed by their investigator until the participant no longer meets the rescue criteria.

Arms:
arm 1: Ertugliflozin, 5 mg, oral, one 5 mg ertugliflozin tablet and one placebo tablet, once daily for 52 weeks arm 2: Ertugliflozin, 15 mg, oral, one 5 mg and one 10 mg tablet, once daily for 52 weeks arm 3: Matching placebo

Interventions: intervention 1: Ertugliflozin 5 mg intervention 2: Placebo 5 mg intervention 3: Ertugliflozin 10 mg intervention 4: Placebo 10 mg
Intervention descriptions: intervention 1: Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks intervention 2: Placebo to ertugliflozin, oral, tablet, 5 mg tablet once daily for 52 weeks intervention 3: Ertugliflozin, oral, tablet, 10 mg tablet once daily for 52 weeks intervention 4: Placebo to ertugliflozin, oral, tablet, 10 mg tablet once daily for 52 weeks

Protocol document: