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The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study


GRADE is a multi-center randomized clinical trial to evaluate the relative long-term metabolic and clinical effects of four classes of drugs in combination with metformin for the treatment of type 2 diabetes.

IRB Protocol Number

All Other Trials

  • Diabetes
  • Endocrine (Hormones)
Brad Wine at 720-848-5596
Eligibility and Other Participant Information

Inclusion Criteria:

1. Men or women ≥30 years of age at time of diabetes diagnosis; for American Indians, age is >20 years at time of diagnosis

2. Duration of diagnosed diabetes <5 years

3. HbA1c 6.5-8.5%

4. Daily dose of >1000 mg metformin for a minimum of 8 weeks


Exclusion Criteria:

1. Type 1 diabetes

2. Current or previous (within past 6 months) treatment with any diabetes drug/glucoselowering medication other than metformin

3. More than 5 years of treatment with metformin at time of randomization

4. History of or planning bariatric surgery, including banding procedures or surgical gastric and/or intestinal bypass

5. History of congestive heart failure (NYHA 3 or greater)

6. History of pancreatitis

7. History of MEN-2 or family history of medullary thyroid cancer

8. History of cancer, other than non-melanoma skin cancer, that required therapy in the 5 years

9. History of severe liver disease

10. Previous organ transplant

11. History of anemia


  • University of Colorado Hospital (UCH)
    12605 E. 16th Ave.
    Aurora, CO 80045