Trial Information

Overweight with Type II Diabetes?

This is a Phase II, randomized, double-blind placebo controlled study to evaluate the safety, efficacy and tolerability of an investigational medication administered in patients that are naive of diabetic medications, metformin only or metformin/sulfonylurea treatment. The study consists of 30 weeks with 11 office visits. You may be compensated for each completed office visit upon completion of the study.

Patient Inclusion Criteria:

Male/female 18 to 70
BMI must be >27.0-<45.0
Diagnosed with type II diabetes
HbA1c must be between 7.0% and 10%
Taking metformin (1500 mg daily) or alone or in combo with sulfonylurea
Cannot have any changes in dose for at least 2 months
Males/females must agree to use proper form of birth control

Patient Exclusion Criteria:

History or presence of type I diabetes or pancreatitis, acute ketoacidosis, lactic acidosis, hyperosmolar coma within the past 6 months
History of MI, unstable angina, class III/IV heart failure, PTCA, CABG, CVA, TIA within the past 6 months. Or history of severe peripheral vascular disease, or uncontrolled HTN
History of CA, BCC or SCC or carcinoma in situ of the cervix
History or presence of anorexia nervosa, bulimia nervosa, or binge eating disorder
History of acute or chronic gastrointestinal condition considered Clinically relevant (inflammatory bowel disease, IBS, or celiac sprue
Any unstable medical conditions

Lisa Dunham, Recruiting
Renstar Medical Research
104 SE 1st Ave Suite B
Ocala, FL 34471
Phone: 352-629-5800 ext 105
Fax: 352-629-7794
Email: renstar@renstar.net

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Research Center Information: Renstar Medical Research

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

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