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

Eli Lilly and Company

Overview

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

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Interventions

naveglitazarDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (42)

Data from ClinicalTrials.gov

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