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Non-Insulin Liraglutide Approved for Pediatric Type-2 Diabetes

Almost 64% of Patients Showed Decreased Hemoglobin A1c Levels

The FDA has approved the first non-insulin drug for type-2 diabetes (T2D) in pediatric patients since metformin’s approval in 2000. Liraglutide (Victoza, Novo Nordisk) injection for the treatment of children aged 10 years or older with T2D. The drug has been approved to treat adults with T2D since 2010.

Although T2D mainly occurs in patients older than 45 years, there has been a drastic increase in the number of younger cases during the last 20 years. More than 5,000 new cases of T2D in the U.S. are diagnosed annually in people below the age of 20, according to CDC estimates.

Liraglutide improves blood sugar levels by creating similar effects in the body to the glucagon-like peptide (GLP-1) receptor protein in the pancreas, which is often at insufficient levels in patients with T2D. The drug slows digestion, prevents the liver from making too much glucose, and helps the pancreas produce more insulin when needed.

The efficacy and safety of liraglutide for reducing blood sugar was studied in a placebo-controlled trial with 134 children aged 10 years and older for more than 26 weeks. Approximately 64% of children taking liraglutide had a reduction in hemoglobin A1c (HbA1c) below 7%, compared to 37% of children taking placebo. Participants taking liraglutide also had a higher hypoglycemia risk, whether or not they took other therapies for diabetes.

Liraglutide carries a boxed warning about the increased risk of thyroid C-cell tumors. Patients who have had, or who have family members who have ever had medullary thyroid carcinoma should not use the drug. Also, patients with multiple endocrine neoplasia syndrome type 2 (MEN 2), an endocrine system condition, should not take liraglutide.

Luraglitide is not a substitute for insulin and is not indicated for patients who have type-1 diabetes or diabetic ketoacidosis.

The drug’s label also warns about pancreatitis; dangers associated with liraglutide pen-sharing; hypoglycemia, when used with other drugs that cause hypoglycemia, including insulin and sulfonylureas; renal impairment or kidney failure; hypersensitivity; and acute gallbladder disease. The most common side effects are nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.

The FDA granted liraglutide a priority review designation. 

Source: FDA, June 17, 2019

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