Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults

NCT00737633 | Terminated Phase 2 Results

• 1 other identifier: DM-231
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 9

Brief Summary

This study is an extension of a study that has been ongoing for 1 year. The purpose of this open label study is to see the how well type 2 diabetics respond to VI-0521(phentermine/topiramate) in controlling blood sugar and how safe VI-0521 is over an extended period of time. All subjects eligible to enroll into this study will receive study drug.

Conditions

Diabetes

Keywords

Diabetes; Type 2 Diabetes; Diabetes Mellitus; Metabolic Diseases; Glucose Metabolism Disorders; Glycemic Control

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c From Baseline to Week 72

  Baseline to 72 weeks

Secondary Outcomes (1)

• Percent Weight Change From Baseline to Week 72

  Baseline to 72 weeks

Study Arms (2)

16-Week population

EXPERIMENTAL

Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)

Drug: VI-0521

72-Week population

EXPERIMENTAL

Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)

Drug: VI-0521

Interventions

VI-0521 DRUG

Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks

16-Week population; 72-Week population

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have completed the qualifying DM-230 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
• Be greater than 80% compliant in study medication use during the last three visits for DM-230

You may not qualify if:

• Subjects who have developed one or more morbidities during the DM-230 trial that would pose a safety concern

Sponsors & Collaborators

• VIVUS LLC: lead
• Synteract, Inc.: collaborator
• Sentrx: collaborator

Study Sites (9)

Research Site

Birmingham, Alabama, United States

Location

Research Site

Los Angeles, California, United States

Location

Research Site

San Francisco, California, United States

Location

Research Site

Spring Valley, California, United States

Location

Research Site

Walnut Creek, California, United States

Location

Research Site

Bethesda, Maryland, United States

Location

Research Site

Austin, Texas, United States

Location

Research Site

San Antonio, Texas, United States

Location

Research Site

Richmond, Virginia, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Diseases; Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Wesley W Day, PhD
• Organization: Vivus, Inc

day@vivus.com

650-934-5200

Study Officials

• Barbara Troupin, MD, MBA

  VIVUS LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2008
• First Posted: August 19, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 10, 2012
• Results First Posted: September 3, 2012

Record last verified: 2012-09

Locations

US (9)