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
- Conditions
- Health Condition 1: null- Type 2 Diabetes MellitusHealth Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2009/091/000614
- Lead Sponsor
- Merck Co Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 276
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method