Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics

VIVUS LLC210 enrolled

Overview

The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to placebo in the glycemic management of obese diabetic adults.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

210

Conditions

Type 2 Diabetes Mellitus

Interventions

VI-0521DRUG

phentermine 15mg/topiramate 100mg

PlaceboDRUG

matched placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed consent * Type 2 Diabetes * BMI 27-42 * Specified diet/exercise and/or diabetes medications Exclusion Criteria: * BP \> 150/95 * Stroke/MI/unstable cardiovascular disease within 6 months * Clinically significant renal, hepatic, or psychiatric disease * Unstable thyroid disease or replacement therapy * Nephrolithiasis * Obesity of known genetic or endocrine origin * Participation in a formal weight loss program or lifestyle intervention * History of glaucoma * Pregnancy or breastfeeding * Alcohol abuse * Eating disorder * Excluded medications

Locations (9)

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

Outcomes

Primary Outcomes

Change From Baseline in HbA1c at Week 28.

Time frame: Baseline to 28 weeks

Secondary Outcomes

Absolute Weight Change (kg) From Baseline to Week 28

Time frame: Baseline to 28 weeks

Data from ClinicalTrials.gov

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