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

Clinical Trial Details

Overview

Research Study Summary

Need help controlling your Type II Diabetes?

Purpose

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?

To Learn more
Phase

4

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Duration

24 Weeks

Facility Type

N/A

Contact

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

View Map

Research Center Information: Renstar Medical Research

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 156858

Date Last Changed: July 24, 2013


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