The purpose of the study is to determine what effect the study drug (in tablet form) has on the body when given with Metformin (an FDA-approved drug). In addition, the study will determine the safety of the two drugs given together with food in subjects with type II diabetes.

 

Vital signs, ECGs, physical examinations, 24 hour telemetry, blood and urine samples will be obtained or performed during this study.

 

Qualified Participants will complete:

 

·          Up to 2 screening visits

·          18 overnight stays (consecutive)

·          3 outpatient visits

 

You may be compensated up to $4350.00 for time and travel.

 

If you are able to answer “YES” to the following statements, you may qualify for this study.

 

I am a male or female type II diabetic between the ages of 18-65.

 

I am taking Metformin twice daily to control my diabetes and have been taking the same dose for the past 60 days.

 

My BMI is between 25 and 38.0 kg/m^2.

 

 

Female subjects must meet one of the following criteria to continue:

 

I am surgically sterile (hysterectomy, and/or tubal ligation and have documentation).

 

I am postmenopausal (no period for at least 24 months).

 

I am willing to use a condom with spermicide from admission day until 2 weeks after the last dose of study drug.

 

Male subjects only: must be willing to use and continue to use a condom with spermicide from admission until 2 weeks after the last dose of study drug or be sterile.

    

 I have not been treated with an investigational drug in the last 30 days.

 

I have not been treated with this investigational drug before.

 

I have not used any tobacco products (cigarettes, pipe, chewing tobacco, nicotine patch, nicotine gum) in the last 6 months or I smoke 5 cigarettes or less per day and am willing to refrain from smoking during the overnight stay at the unit.

 

I have not donated blood in the past 42 days, plasma in the last 14 days or received blood products in the past 56 days.

 

I do not have a history of hypersensitivity to or significant drug allergies.

 

I do not have a history of hypoglycemic episodes while taking Metformin.

 

I do not have a history of drug or alcohol addiction in the last year.

 

I do not have a history of any of the following:

 

  

It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures. Frequently, subjects do not qualify because of medical history, or minor changes in vital signs, ECG and lab tests.   Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come first served basis, and studies may complete enrollment prior to your visit. Additionally, no guarantees can be made regarding group assignments for any particular study.  ICON will not assume any liability for lost time, travel or failure to qualify.

 

To fully qualify, it will be necessary to obtain blood samples after a 10 hour fast. You have the option of coming to the screening appointment fasting or you may return at a later date to obtain fasting blood work. If you choose to come fasting, you will need to refrain from eating or drinking anything (with the exception of water) 10 hours before your appointment.

 

We will be testing for alcohol and illegal drugs. You have the option of obtaining a urine sample at the screening appointment or you may return at a later date to obtain urine for an alcohol and drug sample.

 

If you are able to answer “YES” to the above questions and would like to make an appointment online please click on the following link:

 

Appointments cannot be made online. Please call 210-CALL IDS (225-5437)  or 1-877-848-7425.

 

Notice:

 

In order to schedule a screening appointment online, you will be required to enter your personal information (name, DOB, etc.) into a secure, password protected database. Your information will remain confidential and will not be accessible by any party that does not work directly for ICON Clinical Research. It may be necessary for the recruitment staff to contact you by phone in the event of a schedule change or if more information is needed. You have the right to remove your information from the database at anytime by logging in to the scheduling program and choosing “My Profile” and then selecting the “Terminate Account” button.