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OpenTrials
Completed

NCT Number: NCT00486291

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

VI-0521

Drug

phentermine 15mg/topiramate 100mg

Placebo

Drug

matched placebo

Primary outcomes

  1. Change From Baseline in HbA1c at Week 28.

    Time frame: Baseline to 28 weeks

Secondary outcomes

  1. Absolute Weight Change (kg) From Baseline to Week 28

    Time frame: Baseline to 28 weeks

Sponsors and collaborators

Lead sponsor

VIVUS LLC

Industry

Collaborators

  • Synteract, Inc.

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 14, 2007
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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