NIH’s GRADE study will compare long-term benefits of common diabetes drugs

Researchers are recruiting patients for an NIH-funded trial that aims to compare the long-term effects of commonly prescribed medications on glucose levels, adverse effects, diabetes complications and quality of life during an average of 5 years.

According to clinicaltrials.gov, the Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 Diabetes (GRADE) is a pragmatic, unmasked clinical trial that will compare commonly used diabetes medications (ie, glimepiride [Amaryl, Sanofi-Aventis]; sitagliptin [Januvia, Merck]; liraglutide [Victoza, Novo Nordisk] and insulin glargine [Lantus, Sanofi-Aventis]) plus metformin and their effects on glycemic-lowering effectiveness and patient-centered outcomes.

Primary outcome measures include the time to HbA1c >7%, and secondary outcome measures will include the time to HbA1c >7.5%.

Other outcome measures include time to HbA1c of >7.5% while administered study medications and basal insulin. Additionally, the tertially metabolic outcome is the time to an HbA1c >7.5% while administered metformin, the originally assigned medication and basal insulin, according to clinicaltrials.gov.

“This study will help us understand how different combinations of medications affect the disease over time, and ultimately help physicians make better choices for their patients’ long-term care,” Barbara Linder, MD, PhD, the GRADE project officer at the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases, said in a press release.

For more information:

Clinicaltrials.gov. NCT01794143. Accessed June 3, 2013.

Disclosure: GRADE (NCT01794143) is supported under NIH grant U01DK098246. Additional support in the form of donation of supplies for GRADE comes from BD Medical, Bristol-Myers Squibb, Merck, the National Diabetes Education Program, Novo Nordisk, Roche Diagnostics and Sanofi-Aventis.