THE GLYCEMIA REDUCTION APPROACHES IN DIABETES: A COMPARATIVE EFFECTIVENESS STUDY (GRADE)
Principal Investigator: John M. Lachin, Sc.D.
Co-Investigator: Heidi Krause-Steinrauf, M.S.
The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study is a randomized clinical trial in patients with recent-onset (<5 years duration) type 2 diabetes that will compare the metabolic effects of four commonly used diabetes medications to maintain normal glucose levels over a clinically meaningful duration. This is a large multicenter trial that will be conducted at 40+ clinical sites and will enroll 6000 participants for treatment and follow-up for a total treatment duration of up to 6 years. The four randomly assigned medications are the sulfonylurea glimepiride, the DPP-4 inhibitor sitagliptin, the GLP-1 agonist liraglutide, and the basal insulin glargine. The GRADE study has the potential for a major public health impact in the treatment of type 2 diabetes with immediate translation and is a high research priority for the NIH.
In the fall of 2010 NIDDK awarded a 2-year planning grant for GRADE to develop the protocol, informed consents, manual and forms, and to select all the participating sites and central units. The full grant for the study has been reviewed by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and been approved for funding. The study is planned for launch in the spring of 2013 in clinical sites across the United States. The George Washington University is the prime awardee and will initially be funded for 5 years.
Funded by NIH/NIDDK, (through a subagreement with Massachusetts General Hospital) 1U34DK088043-01A1.)