This is a Phase 1 study, involving a 10-day dosing period, designed to test the safety of investigational study drug ARRY-403 (as monotherapy or in addition to stable metformin therapy) in patients with Type 2 diabetes. Approximately 128 patients from the US will be enrolled in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
128
multiple dose, escalating
matching placebo
Profil Institute for Clinical Research
Chula Vista, California, United States
Cetero
San Antonio, Texas, United States
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
Time frame: Duration of study
Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations.
Time frame: 10 days
Assess the effect of study drug on glycemic control as determined by an oral glucose tolerance test (OGTT).
Time frame: 10 days
Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.
Time frame: 10 days
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