IRB Number:

07-008356

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

Effect of an investigational drug, liraglutide vs placebo or a well known FDA approved anti-diabetic drug, glimepiride, in subjects with type 2 diabetes to see if liraglutide will improve blood flow and blood sugar control. Individuals on diet or metformin alone may be eligible.

Who is Eligible to Participate in the Study?

Volunteers, in good health, with type 2 diabetes between the ages of 40-70 on either diet or metformin therapies for diabetes.

Minimum Age:

40

Maximum Age:

70

What is Involved With this Study?

At every visit, you will be asked to provide information on your diabetes therapy, hypoglycemic episodes(too low blood sugar), any unexpected reactions they you may have experienced, and any change in medications. A physical exam, routine blood work and exercise stress electrocardiogram will be conducted at the first or screening visit. The two "inpatient" days will involve placement of a catheter in one arm for giving insulin and sugar solutions and another in the vein in the back of your hand to be used for periodic blood draws. Wires will be attached to your chest to record your heart rate. Once a drug has been assigned, you will be asked to follow specific instruction for a 12 week treatment period.

Remuneration will be offered to those who participate in this research study.

How long will the Study run?

The study consists of a 2 week screening period, a 12 week treatment period and a 1 week follow up period for a total commitment of 15 weeks. Participation includes a total of 5 visits to the Clinical Research Unit. Two of these visits, "inpatient days", involve a full day commitment (10 hrs) but not an overnight stay.

Who can I Contact for Additional Information on this Trial?

Dr. Andy Basu - phone 255-6752 or e-mail: basu.ananda@mayo.edu

or

Arlene Morris - phone 255-4514 or e-mail: morris.arlene@mayo.edu

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 03/18/2008