CTRI/2009/091/000614OtherPhase 2
A Phase IIa, Multicenter, Randomized, Placebo- and Active-Comparator Controlled, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK-3577 in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Trial Snapshot
- Phase
- Phase 2
- Status
- Other
- Sponsor
- Merck Co Inc
- Enrollment
- 276
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Patient has type 2 diabetes
- •Patient is either not taking antihyperglycemic medications for the last 10 weeks OR is taking a single oral antihyperglycemic medication (but not a 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 patient is unable to have children
Exclusion Criteria
- •Patient has a history of type 1 diabetes or ketoacidosis
- •Patient has been treated with a PPARg agonist in the last 12 weeks
- •Patient has been treated with insulin in the last 12 weeks
- •Patient has had statin therapy in the last 12 weeks
- •Patient is on a weight loss program that is not in the maintenance phase or has been treated with a weight loss medication in the last 8 weeks
- •Patient has a history of coronary artery disease
- •Patient has had a stroke or transient ischemic attack
- •Patient has congestive heart failure
- •Patient is HIV positive
- •Patient has a history of cancer except certain skin or cervical cancers
- •Patient is not willing to abstain from alcohol for 48 hours prior to each clinic visit
- •Patient is breast-feeding
- •Patient will donate eggs during the study
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