Trial Information

Need help controlling your Type II Diabetes?

This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of an investigational drug administered through self –injector device along with Metformin in patients with type 2 diabetes who are not adequately controlled with Metformin. The study consists of 24 weeks with up to 15 office visits and 6 phone calls. You may be compensated for each completed office visit for your time and travel upon completion of study.

Patient Inclusion Criteria:

Male/female 18 and older
BMI >44 (Weight change cannot be more that 11 lbs. during the past 3 months)
HbA1c <7%->10%
Diagnosed with type II diabetes for at least 1 year (DM I is exclusionary)
Women of childbearing potential must use effective birth control method throughout entire course of study

Patient Exclusion Criteria:

Cannot be on any other medication for DM within the past 3 months
Not sufficiently controlled on the current dose of your Metformin (Must be taking a stable dose of Metformin for at least 1500 mg/day for the past 3 months)
History of MI, stroke, or heart failure requiring hospitalization within the past 6 months prior to screening
Uncontrolled or inadequately controlled HTN
History of cardiovascular, hepatic, neurological, endocrine, CA, systemic disease or short life expectancy, diabetic retinopathy, macular edema requiring laser treatment
Have Hep B, C
Used an investigational drug within the past 3 months?

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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