At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study To Evaluate The Safety, Tolerability And Efficacy Of Once Daily PF-04971729 And Hydrochlorothiazide In Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic And Blood Pressure Control
In Brief
A Phase 2 clinical trial evaluating Placebo to Ertuglilflozin 1 or 5 mg, Ertugliflozin 1 mg, and 5 other interventions for Diabetes Mellitus, Type 2 and Hypertension. Completed, enrolled 194 participants.
Detailed Summary
MK-8835-042 (B1521004) is designed to assess the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729), in participants with type 2 diabetes and hypertension. Participants in the study will receive 1 of 5 treatments for 28 days (either placebo, 1 of 3 doses of ertugliflozin \[1, 5, or 25 mg\], or the approved drug hydrochlorothiazide \[HCTZ\]). The primary hypothesis of the study was that ertugliflozin was superior to placebo on the change from baseline in average, 24-hour systolic blood pressure (SBP) on Day 28.
Study Details
Timeline
Interventions
Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days
Ertugliflozin tablet 1 mg once daily for 28 days
Ertugliflozin tablet 5 mg once daily for 28 days
Ertugliflozin tablet 25 mg once daily for 28 days
Hydrocholorthiazide (HCTZ) 12.5 mg capsule once daily for 28 days
Placebo to HCTZ 12.5 mg capsule once daily for 28 days
Placebo to ertuglilflozin tablet 25 mg once daily for 28 days