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

Vivus

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: VI-0521; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00486291

OB-202

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

210 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Phentermine 15mg/topiramate 100mg

Treatment:

Drug: VI-0521

2

Placebo Comparator group

Description:

Matched placebo

Treatment:

Drug: Placebo