An Evaluation of an Oral Antidiabetic Agent for the Treatment of Type 2 Diabetes
Phase 2
Completed
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Registration Number
- NCT00065312
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
🇺🇸Spokane, Washington, United States