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NIH Compares Diabetes Drugs in Head-to-Head Trial

Metformin will be combined with other therapies in 5-year study (June 3)

The National Institutes of Health (NIH) is recruiting volunteers to participate in a study to compare the long-term benefits and risks of four widely used diabetes drugs in combination with metformin, the most common first-line medication for treating type-2 diabetes. The new project is called the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) study.

If metformin is not enough to help manage type-2 diabetes, physicians may add one of several other drugs to lower glucose. But while short-term studies have demonstrated the efficacy of different treatments when used with metformin, no long-term studies have been conducted to determine which combination works best and has fewer side effects.

The GRADE trial aims to enroll about 5,000 patients. The study will compare drug effects on glucose levels, adverse effects, diabetes complications, and quality of life over an average period of nearly 5 years.

During the trial, all of the participants will be treated with metformin along with a second therapy randomly assigned from among four classes of medications.

Three of the classes of medications increase insulin levels. They are: sulfonylureas, which increase insulin levels directly; DPP-4 inhibitors, which indirectly increase insulin levels by increasing the effect of a naturally occurring intestinal hormone; and GLP-1 agonists, which increase the amount of insulin released in response to nutrients. The fourth type of medication is long-acting insulin.

“What differentiates GRADE from previous studies is that it will perform a head-to-head comprehensive comparison of the most commonly used drugs over a long period of time,” said David M. Nathan, MD, a principal investigator.

“In addition to determining which medications control blood glucose levels most effectively over time, we hope to examine individual factors that are associated with better or worse response to the different medications,” Nathan said. “This should provide understanding of how to personalize the treatment of diabetes.”

Source: NIH; June 3, 2013.

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