AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus
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AVANDAMET Compared to Metformin Evaluation Trial (ACME): A 48-week Randomized, Open-label, Multicenter Study to Compare the Efficacy and Tolerability of AVANDAMET to Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Control on Submaximal Metformin.
Study Start Date :
June 25, 2003
Actual Primary Completion Date :
December 1, 2005
Actual Study Completion Date :
December 16, 2005
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients between 18 and 75 years of age with Type 2 Diabetes Mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening).
Patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening.
Women must be post-menopausal, surgically sterile or using acceptable contraceptive measures.
Prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones.
Have a known hypersensitivity to thiazolidinediones or biguanides.
Currently using insulin or any oral anti-diabetic agent other than metformin.
History of metabolic acidosis.
History of substance abuse.
Have active cancer other than localized squamous or basal cell carcinoma.
Chronic disease requiring treatment with corticosteroids.
Other criteria will be evaluated at the screening visit.