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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VI-0521
Placebo
Sponsored by
VIVUS LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes, Obese diabetics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Phentermine 15mg/topiramate 100mg

Matched placebo

Outcomes

Primary Outcome Measures

Change From Baseline in HbA1c at Week 28.

Secondary Outcome Measures

Absolute Weight Change (kg) From Baseline to Week 28

Full Information

First Posted
June 12, 2007
Last Updated
September 5, 2012
Sponsor
VIVUS LLC
Collaborators
Synteract, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00486291
Brief Title
Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics
Official Title
A Phase 2, Randomized, Double Blind, Parallel Design Study Comparing the Efficacy and Safety of VI-0521 to Placebo in the Glycemic Management of Obese Diabetic Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VIVUS LLC
Collaborators
Synteract, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes, Obese diabetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Phentermine 15mg/topiramate 100mg
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Matched placebo
Intervention Type
Drug
Intervention Name(s)
VI-0521
Intervention Description
phentermine 15mg/topiramate 100mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matched placebo
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1c at Week 28.
Time Frame
Baseline to 28 weeks
Secondary Outcome Measure Information:
Title
Absolute Weight Change (kg) From Baseline to Week 28
Time Frame
Baseline to 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Troupin, MD, MBA
Organizational Affiliation
VIVUS LLC
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
Research Site
City
Spring Valley
State/Province
California
Country
United States
Facility Name
Research Site
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Research Site
City
Bethesda
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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