At a glance
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A 12-Week, Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Evaluate the Safety, Tolerability and Efficacy Of Once Daily PF-04971729 And Sitagliptin On Glycemic Control And Body Weight In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
In Brief
A Phase 2 clinical trial evaluating Placebo to Ertugliflozin, Ertugliflozin 1 mg, and 5 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 375 participants.
Detailed Summary
MK-8835-016 (B1521006) is designed to evaluate the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729) in participants with Type 2 diabetes mellitus. Participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment with an approved drug (sitagliptin) for the treatment of Type 2 diabetes mellitus.
Study Details
Timeline
Interventions
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Tablet, 1 mg, once daily for 84 days
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
Tablet, 25 mg, once daily for 84 days
Tablet, 100 mg, once daily for 84 days
Tablet, matching placebo to 100 mg, once daily for 84 days
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).