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Therapeutic Areas: Endocrinology | Family Medicine
Disease Category: Diabetes Mellitus, Type 2
Location: United States, FL
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
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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