NCT00065312

Brief Summary

The purpose of this study is to determine if an investigational drug is safe and efficacious for poorly controlled type 2 diabetes mellitus.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

42 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2003

Completed
Last Updated

July 19, 2006

Status Verified

July 1, 2006

First QC Date

July 21, 2003

Last Update Submit

July 18, 2006

Conditions

Keywords

Type 2 diabetes

Interventions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Type 2 Diabetes for at least 3 months.
  • Diabetes managed with diet and exercise alone or with either metformin or sulfonylurea alone as an adjunct to diet and exercise.
  • Diabetes therapy must be unchanged for at least 3 months prior to screening.
  • Females must be of non-childbearing potential (surgically sterilized or at least 1 year post-menopausal, as defined by cessation of menses). Female patients who are not surgically sterilized and who are less than or equal to 45 years should have their post-menopausal status confirmed by FSH greater that 30ng/mL at screening.

You may not qualify if:

  • Current use of insulin or any antidiabetic agent other than a sulfonylurea agent or metformin.
  • Current use of metformin or a sulfonylurea agent in combination.
  • History of liver disease.
  • History of unstable angina (as defined by the Braunwald system), myocardial infarction, or a coronary revascularization procedure within the past 6 months.
  • Currently suspected carcinoma or history of carcinoma in the last 5 years, with the exception of excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (42)

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Birmingham, Alabama, United States

Location

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Huntsville, Alabama, United States

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Peoria, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Bakersfield, California, United States

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Pico Rivera, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Denver, Colorado, United States

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Waterbury, Connecticut, United States

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West Hartford, Connecticut, United States

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Clearwater, Florida, United States

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Kissimmee, Florida, United States

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Ocala, Florida, United States

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St. Petersburg, Florida, United States

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Decatur, Georgia, United States

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Honolulu, Hawaii, United States

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Orland Park, Illinois, United States

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Peoria, Illinois, United States

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Evansville, Indiana, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Edina, Minnesota, United States

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Minneapolis, Minnesota, United States

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Endwell, New York, United States

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Great Neck, New York, United States

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Charlotte, North Carolina, United States

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Fayetteville, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Allentown, Pennsylvania, United States

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Fleetwood, Pennsylvania, United States

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Lansdale, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Mt. Pleasant, South Carolina, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Lebanon, Virginia, United States

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Renton, Washington, United States

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Spokane, Washington, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

naveglitazar

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 21, 2003

First Posted

July 22, 2003

Last Updated

July 19, 2006

Record last verified: 2006-07

Locations