Safety and Efficacy Study of JTT-130 in Obese Type 2 Diabetic Patients
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Phase II, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety and Tolerability of JTT-130 in Treatment-naïve, Metformin Only or Metformin Plus Sulfonylurea-treated Obese Type 2 Diabetic Patients
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Have type 2 diabetes;
Body mass index (BMI) of > 27.0 kg/m2 and ≤ 45.0 kg/m2;
Are either drug naïve with respect to hypoglycemic agents OR are currently being treated with metformin alone or in combination with a sulfonylurea. Metformin and sulfonylurea dosing must be stable.
Females who are pregnant or breast-feeding
Known medical history or presence of type 1 diabetes, pancreatitis, unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
Acute coronary syndrome or uncontrolled hypertension;
Does not meet medication restriction criteria, as described in the protocol.