A Study of the Safety and Efficacy of MK-3577 in Participants With Type 2 Diabetes Mellitus (MK-3577-009)

• Status: Terminated
• Trial end date: 2010-07-13
• Target enrollment: 0
• Participant gender: All

Summary

This study assessed the safety and efficacy of MK-3577. The primary efficacy hypothesis was that, after 4 weeks of treatment, either the morning (AM) administration or the evening (PM) administration of MK-3577 provides superior reduction of 24-hour weighted mean glucose (WMG) levels compared to placebo (PLA). The primary safety hypothesis was that MK-3577 is well tolerated compared to placebo.

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Participant has type 2 diabetes

• Participant is either not taking antihyperglycemic medications for the last 10 weeks OR is taking a single oral antihyperglycemic medication (but not a Peroxisome Proliferator-Activated Receptor gamma [PPARg] agonist) OR is taking a low-dose combination oral antihyperglycemic medication (not a PPARg agonist) at dose less than or equal to 50% of the maximum dose

• Female participant is unable to have children

Exclusion Criteria:

• Participant has a history of type 1 diabetes or ketoacidosis

• Participant has been treated with a PPARg agonist in the last 12 weeks

• Participant has been treated with insulin in the last 12 weeks

• Participant has had prescription lipid-modifying drug therapy in the last 12 weeks

• Participant has a history of coronary artery disease

• Participant has had a stroke or transient ischemic attack

• Participant has congestive heart failure