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

Study Timeline

• Study First Submitted: 2003-07-21
• Study First Submitted QC: 2003-07-21
• Study First Posted: 2003-07-22
• Status Verified: 2006-07
• Last Update Submitted: 2006-07-18
• Last Update Posted: 2006-07-19

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

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