An Evaluation of an Oral Antidiabetic Agent for the Treatment of Type 2 Diabetes
Completed · Phase 2
Conditions studied: Diabetes Mellitus, Non-Insulin-Dependent
In brief
The purpose of this study is to determine if an investigational drug is safe and efficacious for poorly controlled type 2 diabetes mellitus.
Key facts
- Study ID
- NCT00065312
- Run by
- Eli Lilly and Company
- Last updated by the study team
- 2006-07-19
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
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- For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559) — Edina, Minnesota, United States
Full record on ClinicalTrials.gov
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