At a glance
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A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) in Subjects With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Background Antihyperglycemic Therapy
In Brief
A Phase 3 clinical trial evaluating Ertugliflozin 5 mg, Placebo 5 mg, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 468 participants.
Detailed 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.
Study Details
Timeline
Interventions
Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks
Placebo to ertugliflozin, oral, tablet, 5 mg tablet once daily for 52 weeks
Ertugliflozin, oral, tablet, 10 mg tablet once daily for 52 weeks
Placebo to ertugliflozin, oral, tablet, 10 mg tablet once daily for 52 weeks