Study Summary:
This is a randomized, double-blind, active-comparator (metformin) controlled study in drug-naive patients with Type II Diabetes Mellitus (T2DM). The duration of the study is 45-weeks, which will include a 1-week screening period and a 44-week double-blind, active treatment period. The active treatment period will consist of Phase A (18-week duration; visit 2 to 5) and Phase B (26-week duration; visit 5 to 7).
Qualified Participants Must:
• Have Type II Diabetes Mellitus
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Be 18 to 78 years of age
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Have HgA1c greater than 7.5
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Not be on any antihyperglycemic agent in the last 4 months
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Male or female on birth control, surgically sterile or post-menopausal
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Have no history of intolerance to metformin
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Have no active liver disease, gall bladder disease, PVD, CHF or HIV
Qualified Participants May Receive:
Glucometer, test strips and lancet for the duration of the study, diabetic medication, physical, blood work and EKG, and $50.00 for time and travel.