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An Evaluation of an Oral Antidiabetic Agent for the Treatment of Type 2 Diabetes
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00065312
First received: July 21, 2003
Last updated: July 18, 2006
Last verified: July 2006
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Purpose
The purpose of this study is to determine if an investigational drug is safe and efficacious for poorly controlled type 2 diabetes mellitus.
| Condition | Intervention | Phase |
|---|---|---|
| Diabetes Mellitus, Non-Insulin-Dependent | Drug: naveglitazar | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
Further study details as provided by Eli Lilly and Company:
Eligibility| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00065312
Show 42 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065312
Show 42 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
More Information
| ClinicalTrials.gov Identifier: | NCT00065312 History of Changes |
| Other Study ID Numbers: |
5837 H7R-MC-GCBD |
| Study First Received: | July 21, 2003 |
| Last Updated: | July 18, 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 |
ClinicalTrials.gov processed this record on June 28, 2017