Harmony Outcomes Study

What we are studying

People with type 2 diabetes have a higher risk of getting cardiovascular disease (disease of the heart and/or blood vessels) than people without diabetes. Cardiovascular disease may cause serious complications such as heart attack or stroke. Albiglutide is a medicine (given as a weekly injection) used to lower blood sugar levels in people with diabetes. The purpose of this study is to find out whether people taking albiglutide for diabetes have a higher or lower risk of developing cardiovascular complications (heart attack, stroke, or death from cardiovascular disease), than people who do not take albiglutide. The study will also look for the possibility of additional benefits of albiglutide on the management of your diabetes. For example, whether abliglutide can delay the time you might need to start on insulin treatment, and whether albiglutide can improve your diabetes control without causing side effects such as weight gain or low blood sugar levels (hypoglycemia). The study will also collect important safety information to help improve understanding about the overall effects of albiglutide (both good and bad).

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 40+

Eligibility Criteria

  • Diagnosis of type 2 diabetes
  • Established cardiovascular disease with at least one of the following:
    • Coronary artery disease
    • Cerebrovascular disease
    • Or peripheral arterial disease
  • Hba1c>7.0
  • Women must be post-menopausal

What is involved

  • You will come for clinic visits every 4 months
  • The study period can last up to 5 years. The length of time depends on when you are enrolled
  • You will receive the study drug or placebo
  • There will be blood draws at regular study visits
  • There will be blood pressure checks
  • There will be biannual physical exams

Compensation

Compensation for participation is available

Contact Information

Study Coordinator
Ethel Kouba
Email
ekouba@wakehealth.edu
Phone
336-713-7243
Principal Investigator
Kristen Hairston, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.