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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00065312
First Posted: July 22, 2003
Last Update Posted: July 19, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
July 21, 2003
July 22, 2003
July 19, 2006
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Complete list of historical versions of study NCT00065312 on ClinicalTrials.gov Archive Site
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An Evaluation of an Oral Antidiabetic Agent for the Treatment of Type 2 Diabetes
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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.
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Interventional
Phase 2
Primary Purpose: Treatment
Diabetes Mellitus, Non-Insulin-Dependent
Drug: naveglitazar
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00065312
5837
H7R-MC-GCBD
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Eli Lilly and Company
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Eli Lilly and Company
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP