Baseline Characteristics of Participants in the Glycemia Reduction Approaches in Diabetes—A Comparative Effectiveness Study (GRADE)

GRADE is an NIDDK-sponsored, 36-center open-label randomized trial comparing the addition of one of the four most commonly used classes of glucose-lowering medications to metformin on long-term glycemic control and patient-centered outcomes in type 2 diabetes (T2D). Between June 2013 and June 2017, GRADE enrolled 5,047 patients age ≥ 30 years (y) (≥20 y in Native Americans [AI/AN]) at time of diagnosis, with T2D of < 10 y, HbA1c 6.8-8.5%, and taking metformin (≥1,000 mg daily). Participants were randomly assigned to glimepiride, sitagliptin, liraglutide, or glargine. The primary metabolic outcome is time to HbA1c ≥7%. At baseline, participants were 57.0±10.0 y, 63.6% male, with racial/ethnic breakdown: 65.8% white, 19.8% African American, 18.4% Hispanic/Latino, 3.6% Asian, and 2.8% AI/AN. Mean HbA1c was 7.5±0.5% and BMI was 34.3±6.8 kg/m². Sixty-nine percent were treated for hypertension; 6.6% had a history of heart attack or stroke. Participant characteristics were comparable across treatment arms. GRADE recruited a diverse cohort to inform decision-making regarding the long-term clinical effectiveness of four major classes of glucose-lowering medications added to metformin. Uniquely, GRADE includes patients with an intermediate duration of diabetes who require a second glucose-lowering medication. Primary results from GRADE are expected in 2021.