DiabeticstudyKI029

Type II Diabetes KI029

San Antonio - Texas

ICON Development Solutions is conducting a research study of an investigational medication in male and female volunteers, 18-80 years old, diagnosed with Type II Diabetes currently being treated by diet and exercise, Metformin, Acarbose, sulfonylureas or a combination of these medications.

The study is designed to find out of there is a difference between taking colesevelam HCl alone or in combination with sitagliptin in terms of their effects on glucose control. Both colesevelam HCl and sitagliptin are approved by the FDA for the treatment of Type II Diabetes.

Vital signs, physical examinations and blood and urine samples will be obtained and performed during this study.

Participants will complete:

· Up to 2 screening visits

· 2 outpatient visits

· 2 overnight stays (non-consecutive)

You may be compensated up to $1250.00 for time and travel.

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

I have Type II Diabetes and am currently being treated with diet and exercise or taking Metformin, Acarbose, sullfonylureas or a combination of these medications.

I am between the ages of 18-80.

My BMI is between 18.5 and 40 kg/m²

Female subjects only:

I am not breastfeeding, pregnant, planning pregnancy or have been pregnant within 6 months of screening

I am surgically sterile (tubal ligation at least 6 months prior to screening or hysterectomy) or postmenopausal (no period for at least 1 year) OR

I am willing to use an approved birth control method (oral, injectable or implantable hormonal contraceptive; IUD, diaphragm plus spermicide or female condom plus spermicide)

I am willing to washout of any oral anti-diabetic medications I may be taking

I am willing to maintain my weight, regular diet and exercise routine throughout the study and have had a stable weight for the last 3 months

I am not on a weight loss program or planning to start a weight loss program

I do not have a history of Insulin use that was required daily for more than 2 months

I have not been treated with a thiazolidinedione (TZD) such as Actos or Avandia in the last 6 months.

I have not been treated with a DPP-4 inhibitor (Januvia or Onglyza) or GLP1 agonist (Byetta or Liraglutide).

I do not have history of any of the following:

Swallowing disorders or difficulty swallowing (dysphagia)
Inflammation or infection of the pancreas (pancreatitis)
Gastrointestinal disorders including:

I do not have any history of type I diabetes or history of diabetic ketoacidosis

If being treated for high blood pressure or high cholesterol, I have been taking the same dose of medication for three months before screening.

I have not been treated for any medical condition requiring antibiotics in the last 3 months.

I do not have any hypersensitivity or history of an allergic or toxic reaction to Januvia or Welchol.

I do not have a history of alcohol or drug substance abuse

I am willing to refrain from smoking during the in house part of this study.

I have not participated in an investigational study or taken an investigational medication in the past 3 months.

I do not have trouble swallowing large pills.

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, EKG 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 has no plans to pay 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 drugs of abuse.

If you are able to answer “YES” to the above questions and would like to make an appointment

please call 210 CALL-IDS (225-5437)

Notice:

In order to schedule a screening appointment, you will be required to provide 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

Study Dates: Note: Dates are examples. Your actual dates will depend on when you screen and start your washout.

Diet Controlled Patients –

Screening

1^st Admit: 24Aug10

Discharge: 25Aug1010

Outpatient Visits: 21Sep10 & 19Oct10

2^nd Admit: 15Nov10

Discharge: 16Nov10

Patients on Sulfonylurea / Acarbose -

Pre-screening

Begin 4 week washout

Screening

Example Dates: Actual dates will depend on when you screen and start your 4 week washout.

1^st Admit: 15Jun10

Discharge: 16Jun1010

Outpatient Visits: 13Jul10 & 10Aug10

2^nd Admit: 06Sep10

Discharge: 07Sep10

Patients on Metformin –

Pre-screening

Begin 8 week washout

Screening

Example Dates: Actual dates will depend on when you screen and start your 8 week washout.

1^st Admit: 24Oct10

Discharge: 25Oct10

Outpatient Visits: 21Nov10 & 19Dec10

2^nd Admit: 15Jan10

Discharge: 16Jan10

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