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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: VI-0521

• Registration Number: NCT00486291
• Lead Sponsor: VIVUS LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-12
• Study First Submitted QC: 2007-06-12
• Study First Posted: 2007-06-14
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Disposition First Submitted: 2009-11-30
• Disposition First Submitted QC: 2009-11-30
• Disposition First Posted: 2009-12-02
• Results First Submitted: 2012-07-31
• Results First Submitted QC: 2012-07-31
• Status Verified: 2012-09
• Results First Posted: 2012-09-03
• Last Update Submitted: 2012-09-05
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Matched placebo
1	VI-0521	Phentermine 15mg/topiramate 100mg

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c at Week 28.	Baseline to 28 weeks

Secondary Outcome Measures

Name	Time	Method
Absolute Weight Change (kg) From Baseline to Week 28	Baseline to 28 weeks

Trial Locations

Locations (1)

Research Site; 🇺🇸 Richmond, Virginia, United States