FDA Okays Trulicity to Treat Adults With Type-2 Diabetes

First Posted: Sep 20, 2014 07:49 AM EDT

The FDA panel has approved 'Trulicity', a subcutaneous injection, to treat adults with type-2 diabetes.

Type-2 diabetes currently affects nearly 26 million people and accounts for over 90 percent of the diabetes cases among Americans. Over the period of the time, high blood sugar levels can up the risk for serious complications that include heart diseases, blindness, and nerve and kidney damage.

In a latest announcement, the U.S. food and Drug Administration revealed that it had given a green signal to Trulicity (dulaglutide), a once-weekly subcutaneous injectio that is enhances the glycemic control along with diet and exercise in those with type-2 diabetes.

"Type 2 diabetes is a serious chronic condition that causes blood glucose levels to rise higher than normal," said Mary Parks, M.D., deputy director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research. "Trulicity is a new treatment option, which can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of type-2 diabetes."

The newly approved Trulicity, is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that regulates the blood sugar levels. The researchers evaluated the safety and effectiveness of the drug through six clinical trials that included 3,342 patients who were diagnosed with type-2 diabetes. These patients who received the drug noticed an improvement in the blood sugar control as seen in reduction in HbA1c level.

This drug has been studied as a stand-alone therapy as well as in combination with other type-2 diabetes therapies that include metformin, sulfonylurea, thiazolidinedione and prandial insulin.

The FDA panel cautions that Trulicity should not be used to treat those with type-1 diabetes, those with high ketones in blood or urine, those with severe stomach or intestinal problems or for those who cannot be managed with diet and exercise.

The drug comes with a boxed warning that tumors of thyroid gland has been seen in rodent studies who were treated with Trulicity. The FDA also demanded a few post marketing studies for Trulicity. During the clinical trail the common side effects noticed was nausea, diarrhea, vomiting, abdominal pain and lower appetite.

The drug is manufactured by Eli Lilly and company.

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