OHSU

IRB #

IRB00009157

Title

Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE)

Principal Investigator

Andrew Ahmann

Study Purpose

In this study, we will compare the effectiveness of four different medications that are used to treat type 2 diabetes. We want to learn:
a. How well different medication combinations control blood sugar levels in people with type 2 diabetes.
b. More about the benefits or side effects of each medication combination.
c. What is the best treatment for type 2 diabetes.

Medical Condition(s)

Type 2 diabetes

Eligibility Criteria

You may be eligible for the study if:
- You have been diagnosed with type 2 diabetes for less than 5 years
- You were at least 30 years of age at time of diabetes diagnosis; or for American Indians, were at least 20 years of age at time of diagnosis.
- You are taking only metformin (Glucophage) to treat your diabetes

Age Range

25 - 100

Healthy Volunteers Needed

No

Duration of Participation

This study is being done in two phases, Phase 1 is screening/run-in and Phase 2 is the GRADE clinical trial. The screening and run-in period (Phase 1) will take about 6-12 weeks to complete. During screening and run-in, you will have 2 or 3 study visits to OHSU. Your participation in the GRADE clinical study (Phase 2) will be for 4 years up to 7 years depending on when you enroll. The study is planned to end in 2020. Phase 2 visits will be every 3 months. Most of these visits will take about an hour. Once each year you’ll have a longer visit (5 hours) that will require that you fast (nothing to eat for at least 8 hours before the visit).

Minors Included

No

Contact

Harold Schnitzer Diabetes Health Center Research Department at 503-494-4650 or GRADE@ohsu.edu

Sponsor

National Institutes of Health (NIH)

Recruitment End

12/31/2015

Compensation Provided

Yes

Compensation

You will be provided $100 per year during your participation in the GRADE study. The payment will be provided after the annual visit each year. We will also pay $10 per visit for local travel costs and provide a small snack if we ask you to fast for an appointment.


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