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

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ClinicalTrials.gov Identifier: NCT00065312
Recruitment Status : Completed
First Posted : July 22, 2003
Last Update Posted : July 19, 2006
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Non-Insulin-Dependent Drug: naveglitazar Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065312


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Sponsors and Collaborators
Eli Lilly and Company
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00065312     History of Changes
Other Study ID Numbers: 5837
H7R-MC-GCBD
First Posted: July 22, 2003    Key Record Dates
Last Update Posted: July 19, 2006
Last Verified: July 2006

Keywords provided by Eli Lilly and Company:
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases