Trial Information

Summary: This study will compare the efficacy, safety, and tolerability of an investigational drug to the efficacy, safety, and tolerability of Glipizide, in inadequately controlled Type II diabetic patients.

Inclusion Criteria:

• Patient must have Type II diabetes.
• Patient is currently on metformin and/or another anti-diabetic medication, the dose of which will be considered on a case by case basis, and meets certain HbA1C level at screening visit/visit 1. Patient may also not need to be on an anti-diabetic medication at screening visit, if he/she meets specific HbA1C level.
• Patient, male or female, is between 18 to 78 years of age.
• Patient is able and willing to adhere to the therapeutic regimens and protocol requirements.
• Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and during post-study follow-up period.

Exclusion Criteria:

• Patient has a diagnosis of uncomplicated/complicated Type I diabetes mellitus.
• Patient required insulin within the previous 8 weeks.
• Patient is on a weight loss program and is not in the maintenance phase.
• Patient started on a weight loss medication within the prior 8 weeks.
• Patient is likely to need long term treatment with steroids (exception: nasal, inhaled, and local treatment with steroid permitted).
• Patient has undergone surgery requiring general anesthesia within 30 days of enrollment in this study.
• Patient has received treatment with an investigational drug within the last 8 weeks before enrollment in this study.
• Patient has a history of certain heart conditions within the past 6 months.
• Patient has a liver disease or symptomatic gall bladder disease.
• Patient is HIV positive.
• Patient has impaired kidney function.
• Patient has certain blood-related diseases.
• Patient has a history of alcohol and drug abuse within the past 3 years.
• Patient has a positive urine pregnancy test at visit 1.

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