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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00065312
Other study ID # 5837
Secondary ID H7R-MC-GCBD
Status Completed
Phase Phase 2
First received July 21, 2003
Last updated July 18, 2006

Study information

Verified date July 2006
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
naveglitazar


Locations

Country Name City State
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United States For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559) Kissimmee Florida
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United States For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559) 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) Ocala Florida
United States For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559) Oklahoma City Oklahoma
United States For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559) Orland Park Illinois
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United States For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559) Renton Washington
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United States For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559) Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

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