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An Evaluation of an Oral Antidiabetic Agent for the Treatment of Type 2 Diabetes

NCT ID: NCT00065312

Last Updated: 2006-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Diabetes Mellitus, Non-Insulin-Dependent

Keywords

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Type 2 diabetes

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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naveglitazar

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

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For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)

Birmingham, Alabama, United States

Site Status

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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

Site Status

Countries

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United States

Other Identifiers

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H7R-MC-GCBD

Identifier Type: -

Identifier Source: secondary_id

5837

Identifier Type: -

Identifier Source: org_study_id