Washington, D.C.- The United States Food and Medicines Administration (FDA) today approved the weekly subcutaneous injections of Trulicity (Dreamaglutida) to improve blood sugar control control for type II diabetes or diabetes mellitus.
The Trulicity is an agonist from the receptor of a peptide similar to glucagon 1, a hormone that helps normalize blood sugar levels, and their safety and effectiveness were evaluated in eight clinical trials with three thousand 342 diabetic patients.
"Those who took Trulicity saw the control of their glycemia level, as seen in the reductions of their HBA1C hemoglobin level," said the FDA.
Type 2 diabetes affects about 26 million people and represents more than 90 percent of cases of diagnostic diabetes in the United States.
High blood sugar levels can raise the risk of serious complications, including heart conditions, blindness, renal damage and nervous system.
"Type 2 diabetes is a serious chronic disease that makes glucose levels higher than normal," he said.
"The Trulicity is a new treatment option that can be used only or incorporated into existing treatment regimes," said Dr. Mary Parks, deputy director of the Office of Medication Evaluation II, of the FDA Evaluation and Research Center.
The Trulicity was studied as an independent therapy, as well as in combination with other therapies for type 2 diabetes, which include metformin, sulfonylurea, thiazolidatediona and prandial insulin.
The FDA made it clear that the Trulicity should not be used to treat people with type 1 diabetes, to whom they have a high number of ketones in the blood or urine, or to those who suffer from intestinal or stomach problems.
He also indicated that tumors of the thyroid gland have been observed in studies on this medication with rodents, but that it is unknown if it causes thyroid C cell tumors, or a type of cancer called thyroid medullary cancer (CMT), in humans.
