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The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study


GRADE

Trial Focus

Trial Focus

Diabetes, Endocrine (Hormones)

Objective

        
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 #

13-0317

Trial Status

Accepting Participants

Contact

Brad Wine at 720-848-5596 or bradley.wine@ucdenver.edu

Location

University of Colorado HospitalUniversity of Colorado Hospital

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