The purpose of the study is to determine the long-term safety and efficacy of VI-0521 (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2 diabetic adults. Continuation of initial 6 month trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
130
phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks
Oral placebo capsules, once daily, 28 weeks
Research Site
Birmingham, Alabama, United States
Research Site
Los Angeles, California, United States
Research Site
San Francisco, California, United States
Research Site
Spring Valley, California, United States
HbA1c Change From Baseline Week 0 to Week 56
Time frame: Baseline to 56 weeks
Percent Weight Loss From Baseline to Week 56
Time frame: Baseline to 56 weeks
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Research Site
Walnut Creek, California, United States
Research Site
Bethesda, Maryland, United States
Research Site
Austin, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Richmond, Virginia, United States