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Completed

NCT Number: NCT00600067

A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phentermine/topiramate

Drug

phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks

Placebo

Drug

Oral placebo capsules, once daily, 28 weeks

Primary outcomes

  1. HbA1c Change From Baseline Week 0 to Week 56

    Time frame: Baseline to 56 weeks

Secondary outcomes

  1. Percent Weight Loss From Baseline to Week 56

    Time frame: Baseline to 56 weeks

Sponsors and collaborators

Lead sponsor

VIVUS LLC

Industry

Collaborators

  • Sentrx
  • Synteract, Inc.

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 24, 2008
Registry last updated
Sep 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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