(HealthDay News) – The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) is a pragmatic clinical trial that will compare the long-term effects of diabetes medications (when combined with metformin) on glucose-lowering efficacy and patient-centered outcomes, according to a report published online May 20 in Diabetes Care.
David M. Nathan, MD, of the Massachusetts General Hospital and Harvard School of Medicine in Boston, and colleagues report the rationale and design of the GRADE study. Recruitment at 37 centers in the United States will begin in 2013.
The researchers plan to enroll 5,000 metformin-treated patients, aged ≥30 years at the time of diagnosis, who have had diabetes for <5 years and have a baseline hemoglobin A1c (A1C) of 6.8–8.5%. Patients will be randomly assigned to receive one of four medications representing four major classes of glucose-lowering medications (a sulfonylurea, a dipeptidyl peptidase 4 inhibitor, a glucagon-like peptide 1 receptor agonist, and insulin). The primary outcome is the time to primary failure, defined as a confirmed A1C ≥7% over an average follow-up period of 4.8 years. Selected microvascular complications, risk factors for cardiovascular disease, adverse effects, tolerability, quality of life, and cost-effectiveness will also be compared among the four drugs.
“GRADE results should not only help practitioners to choose the medications that are the most appropriate with regard to metabolic control and patient-oriented outcomes, but should also provide insights to allow individualization of treatment,” the authors write.
Medications and supplies for the study have been provided by various pharmaceutical companies, and several authors have disclosed financial ties to the pharmaceutical industry.