Victoza: New Treatment Option for Youth with Type 2 Diabetes

FDA OK's liraglutide (Victoza) injections for pediatric patients 10 years and older.

Victoza Injectable Pen and Device BoxVictoza® (liraglutide) injection 1.2 mg or 1.8 mg Pen with packaging. (Photo: Courtesy NovoNordisk)

A new treatment option is now available for children 10 years and older with type 2 diabetes, thanks to  the FDA's OK of liraglutide (Victoza). Already approved and used by adults, Victoza is the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since 2000, when metformin was OK'd.1

The new option, an injection, is both welcome and overdue, doctors who treat children with type 2 diabetes told OnTrackDiabetes. "We are excited because there haven't been other options for children that are FDA-approved except metformin and insulin," says Griselda ("Gia") Alvarez, MD, a pediatric endocrinologist at UCLA Health and a health sciences clinical assistant professor of pediatrics at UCLA's David Geffen School of Medicine.

Jane Lynch, MD, chair of  the American Academy of Pediatrics' Section on Endocrinology, and professor of pediatrics at the University of Texas Health San Antonio, agrees. "Insulin and metformin are inadequate for managing type 2 diabetes in many children," she says. While adults with type 2 diabetes have many options, she says, children do not. She was an investigator on a study that assessed liraglutide in pediatric patients.

While type 2 diabetes mainly occurs in adults over the age of 45, it is becoming more common in younger patients during the last couple of decades, the FDA says. Every year in the US about 5,000 new cases of type 2 diabetes are diagnosed among US youth younger than age 20.2

Since the drug is already on the market and used by adults, health care providers can begin writing prescriptions for Victoza for children immediately if they feel it is an appropriate treatment, says Michael Bachner, a spokesperson for Novo Nordisk, the drug maker. (Some doctors, in fact, were prescribing the drug off-label in their young patients, a practice that is acceptable and legal if the health care provider feels the drug will benefit the patient.)

Now that the drug is approved for pediatric patients, ''insurance coverage will vary, depending on the individual plan," Bachner says.

How Victoza Works

The drug helps improve blood sugar levels by creating the same effects in the body as a protein known as the glucagon-like peptide (GLP-1) receptor protein in the pancreas. In those with type 2 diabetes, levels of this protein are often too low.

The drug mimics what the protein does—slows digestion, prevents the liver from making too much glucose and helps the pancreas make more insulin when needed.

What the Research Shows in Children

The FDA approved the drug in children based on several studies done in adults and one study that compared Victoza with a placebo ("dummy") in pediatric patients for more than 26 weeks.3

In that study, known as the Ellipse Trial, researchers randomly assigned 134 children, ages 10 years to less than 17 years, to take either liraglutide, up to 1.8 milligrams a day, or placebo. (*Note: In the study both liraglutide and the placebo were visually-identical prefilled pen injectors.)

To be eligible for the study, the youth needed to have a body mass index more than the 85th percentile. If they had been treated with diet and exercise alone, their A1C for inclusion had to be between 7-11%. If they were treated with metformin, with or without insulin, their A1Cs were between 6.5-11% if they were included.3

The A1C test, a blood test, assesses average blood sugar levels over the past 2-3 months; an A1C of 5.7% is the beginning of prediabetes; when it reaches 6.5%, it is termed diabetes.

During the study, both groups were also given metformin.

The researchers looked at the change in A1C over the 26 weeks of the study. The average A1C decreased by .64 points with the drug and increased by .42 with the placebo. About 64% of the youth on the drug had a decline in their A1C below 7% while on the drug, but only 37% of those in the placebo group did, the FDA says. Adverse events were similar in the groups—most commonly nausea, vomiting, appetite decline, indigestion and constipation.

The results held in those who also took insulin, as well as in those who did not.

The pediatric patients who took Victoza had a higher risk of low blood sugar (hypoglycemia) regardless of whether they also took other therapies for the diabetes, the FDA says.

There is also an increased risk of thyroid C-cell tumors with Victoza, as a boxed warning cautions So anyone who has a family history or personal history of medullary thyroid cancer, or MTC, should not use the drug. It's also not to be used in those who have an endocrine condition called MEN 2 (multiple endocrine neoplasia syndrome type 2).

What Else to Know

The new approval, and with it, insurance coverage for those who have insurance plans, will potentially mean more children may benefit, Dr. Lynch says. She recalls instances where families whose children could benefit from liraglutide did not get it, as the price without insurance coverage was out of reach.

In her experience, Dr. Alvarez finds that some children have trouble initially injecting themselves. "Most children do get used to it pretty fast," she says. And, she adds, it is just a once-a-day injection, not multiple.

Even with the new approval, Dr. Alvarez say she will continue to recommend diet and exercise and metformin initially and move on to liraglutide when those measures don't work well enough to manage blood sugar.

Dr. Alvarez has no disclosures; Dr. Lynch was a coinvestigator on the Ellipse study. She is on the Novo Nordisk global expert committee for type 2 diabetes in youth, a non-paid position.


 

Updated on: July 8, 2019
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