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

Eli Lilly and Company41 个研究点分布在 1 个国家开始时间: 2003年7月22日最近更新: 2006年7月19日

适应症

试验速览

The purpose of this study is to determine if an investigational drug is safe and efficacious for poorly controlled type 2 diabetes mellitus.

•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.

•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.

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