Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 2 to 5 mg/day will be studied.
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Ages Eligible for Study:
35 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age 35 to 75
Type 2 diabetes for longer than 3 months
HbA1c (glycosylated hemoglobin A1c) greater than 7.0% at screening
FPG (fasting plasma glucose) greater than 126 mg/dL at screening
BMI (body mass index) less than 40 kg/square meter
Type I diabetes
Type 2 diabetes patients currently treated with insulin
Type 2 diabetes patients currently or previously treated with Actos, Avandia or Rezulin
FPG (fasting plasma glucose) greater than 270 mg/dL at baseline