NCT00065312
Completed
Phase 2
An Evaluation of an Oral Antidiabetic Agent for the Treatment of Type 2 Diabetes
ConditionsDiabetes Mellitus, Non-Insulin-Dependent
Drugsnaveglitazar
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Sponsor
- Eli Lilly and Company
- Locations
- 1
- Status
- Completed
- Last Updated
- 19 years ago
Overview
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Not specified
Study Sites (1)
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