Trial Information

Summary: A Phase III Clinical Trial to Evaluate the Effectiveness of a DPP-IV Inhibitor as Adjuvant Therapy for Achieving Glycemic Control in Patients with Type II Diabetes

This Phase III clinical study is designed to evaluate the effectiveness of adding a DPP-IV inhibitor to a dual oral antidiabetic therapy, including metformin, in achieving glycemic control in patients with Type II Diabetes. Qualified subjects who agree to participate and qualify will be asked to complete a 52 week course of treatment followed by and end-of-treatment visit, and a 2-week follow-up visit. All study-related medical exams, laboratory tests, and study medication will be provided at no cost to participants.

Patient Inclusion Criteria

• >18 years old with a diagnosis of Type II Diabetes
• The patient has inadequate glycemic control as defined by HbA1c concentration between 7.0 and 10% while on a stable dose of a combination oral diabetic therapy.
• The patient must have a body mass index between 23 and 45 kg/m2

Patient Exclusion Criteria

• History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for 5 years
• History of laser treatment for proliferative diabetic neuropathy within the past 6 months
• Has New York Association Class II or IV heart failure (Stable Class I or II patients are acceptable

If you would like to learn more about participating in this study, please send an e-mail message using the form below.