Status:
TERMINATED
A Study of the Safety and Efficacy of MK-3577 in Participants With Type 2 Diabetes Mellitus (MK-3577-009)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This was a 4-period/5-treatment crossover study. Each period was 4 weeks. The 5 treatments consisted of MK-3577 10 mg once daily (QD) in the AM, MK-3577 6 mg QD in the evening (PM), MK-3577 25 mg twic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 24 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2010
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00868790
Start Date
March 24 2009
End Date
July 13 2010
Last Update
September 10 2018
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