Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)

• Status: Completed
• Trial end date: 2011-02-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Pfizer
• Treatments: Ertugliflozin; Hydrochlorothiazide

Criteria

Inclusion Criteria:

• Participants with type 2 diabetes and hypertension

• Medically stable

• On at least 1 (and up to 2) oral diabetes drugs

• And up to 2 medicines for blood pressure control

Exclusion Criteria:

• Participants with type 1 diabetes

• Heart attack

• Stroke

• Uncontrolled blood pressure

• Significant kidney disease