NIH begins long-term efficacy study of diabetes drugs

NIH's National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) began the open-label, U.S. Phase III GRADE trial to compare the long-term benefits/risks of four diabetes drugs in combination with metformin in about 5,000 diabetics. Patients will be followed for up to seven years and will receive Januvia sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor from Merck & Co. Inc. (NYSE:MRK); Victoza liraglutide, a long-acting analog of glucagon-like peptide-1 (GLP-1) from Novo Nordisk A/S (CSE:NVO; NYSE:NVO); Lantus insulin glargine, a synthetic sustained-release subcutaneous insulin analog from Sanofi (Euronext:SAN; NYSE:SNY); or glimepiride, a generic sulfonylurea.

GRADE will enroll patients who were diagnosed with Type II diabetes in the last five years and who have not taken any other medication except metformin. The primary efficacy endpoint is time to HbA1c levels greater than or equal to 7%. The trial will also compare safety, diabetes complications and quality of life data. ...