A VI-0521 Study to Evaluate the Long-Term Safety and Efficacy in Type 2 Diabetic Adults - Full Text View

Sponsors and Collaborators:	VIVUS, Inc. Synteract, INC Sentrx
Information provided by:	VIVUS, Inc.
ClinicalTrials.gov Identifier:	NCT00600067

Purpose

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.

Condition	Intervention	Phase
Diabetes	Drug: Phentermine/Topiramate Drug: Placebo	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Topiramate Phentermine Phentermine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double Blind Multicenter Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 Relative to Placebo in Providing and Maintaining Glycemic Control in Type 2 Diabetic Adults

Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:

Demonstrate improvement in glycemic control from baseline relative to placebo as measured by HgbA1c [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The change in other glycemic indicators from baseline relative to placebo [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
Demonstrate improvements in associated metabolic, cardiovascular, and anthropometric risk factors from baseline relative to placebo [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	January 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Phentermine/Topiramate Phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks
2: Placebo Comparator	Drug: Placebo Oral placebo capsules, once daily, 28 weeks

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have completed the qualifying OB-202 trial
If females of child-bearing potential, subjects must be using adequate contraception
Provide written informed consent
Be willing and able to comply with scheduled study visits, treatment plan, lab tests and other study procedures

Exclusion Criteria:

Subjects who have developed one or more morbidities during the OB-202 trial that would pose a safety concern

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600067

Locations

United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, California
Research Site
San Francisco, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Los Angeles, California, United States
Research Site
Spring Valley, California, United States
United States, Maryland
Research Site
Bethesda, Maryland, United States
United States, Texas
Research Site
San Antonio, Texas, United States
Research Site
Austin, Texas, United States
United States, Virginia
Research Site
Richmond, Virginia, United States

Sponsors and Collaborators

VIVUS, Inc.

Synteract, INC

Sentrx

Investigators

Study Director:

Barbara Troupin, MD, MBA

VIVUS, Inc.

More Information

No publications provided

Responsible Party:	VIVUS Inc. ( Wesley Day, VP Clinical )
Study ID Numbers:	DM-230
Study First Received:	January 11, 2008
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00600067 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:

Diabetes
Type 2 Diabetes
Diabetes Mellitus

Metabolic Diseases
Glucose Metabolism Disorders
Glycemic Control

Study placed in the following topic categories:

Neurotransmitter Agents
Metabolic Diseases
Adrenergic Agents
Diabetes Mellitus
Central Nervous System Stimulants
Neuroprotective Agents
Phentermine
Anti-Obesity Agents

Diabetes Mellitus, Type 2
Topiramate
Appetite Depressants
Peripheral Nervous System Agents
Glucose Metabolism Disorders
Metabolic Disorder
Anticonvulsants

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Physiological Effects of Drugs
Central Nervous System Stimulants
Protective Agents
Neuroprotective Agents
Phentermine

Pharmacologic Actions
Anti-Obesity Agents
Autonomic Agents
Therapeutic Uses
Topiramate
Appetite Depressants
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 06, 2009