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

July 18, 2006 updated by: Eli Lilly and Company
The purpose of this study is to determine if an investigational drug is safe and efficacious for poorly controlled type 2 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
      • Huntsville, Alabama, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Arizona
      • Peoria, Arizona, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
      • Tucson, Arizona, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Arkansas
      • Little Rock, Arkansas, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • California
      • Bakersfield, California, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
      • Pico Rivera, California, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
      • San Diego, California, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
      • Santa Ana, California, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Colorado
      • Denver, Colorado, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Connecticut
      • Waterbury, Connecticut, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
      • West Hartford, Connecticut, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Florida
      • Clearwater, Florida, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
      • Kissimmee, Florida, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
      • Ocala, Florida, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
      • St Petersburg, Florida, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Georgia
      • Decatur, Georgia, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Hawaii
      • Honolulu, Hawaii, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Illinois
      • Orland Park, Illinois, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
      • Peoria, Illinois, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Indiana
      • Evansville, Indiana, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Kansas
      • Wichita, Kansas, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Kentucky
      • Louisville, Kentucky, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Maryland
      • Baltimore, Maryland, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Minnesota
      • Edina, Minnesota, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
      • Minneapolis, Minnesota, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • New York
      • Endwell, New York, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
      • Great Neck, New York, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • North Carolina
      • Charlotte, North Carolina, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
      • Fayetteville, North Carolina, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Oregon
      • Eugene, Oregon, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
      • Fleetwood, Pennsylvania, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
      • Lansdale, Pennsylvania, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
      • Philadelphia, Pennsylvania, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • South Carolina
      • MT Pleasant, South Carolina, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Texas
      • San Antonio, Texas, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Utah
      • Salt Lake City, Utah, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Virginia
      • Lebanon, Virginia, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
    • Washington
      • Renton, Washington, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
      • Spokane, Washington, United States
        • For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 21, 2003

First Submitted That Met QC Criteria

July 21, 2003

First Posted (Estimate)

July 22, 2003

Study Record Updates

Last Update Posted (Estimate)

July 19, 2006

Last Update Submitted That Met QC Criteria

July 18, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5837
  • H7R-MC-GCBD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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