Glycemic Reduction Approaches in Diabetes: A Comparative Effectiveness Study

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The goal of our site was to recruit 150 primarily Native American participants into GRADE. Participants will be recruited from the urban population in Phoenix mostly via the Phoenix Indian Medical Center. Potential volunteers will undergo screening examinations, followed by run-in period in which participants are titrated to maximal tolerated dose of metformin. At the completion of the run-in period, participants with hemoglobin A1Cs 6.8-8.5% will be eligible to continue in the study and be randomized to one of the additional medications noted above. Participants will undergo baseline and yearly oral glucose tolerance tests, neuropathy screens, cognitive testing, and health care questionnaires. Urine for albumin will be collected every 6 months. All participants will have their diabetes managed by GRADE staff. Participants whose hemoglobin A1Cs rise above 7.5% on repeated measurements will have their therapy intensified with the addition of insulin glargine or for those already on glargine with the rapid acting insulin aspart at meals. The recruitment began in June, 2013 and was completed in July 2017. We have 142 randomized participants, the study will continue through 2021.