Is Victoza Approved for Children with Type 2 Diabetes?
Victoza (liraglutide) is FDA-approved for children aged 10 years and older with type 2 diabetes, used alongside diet and exercise to improve blood sugar control. Approval came in 2019 based on the ELLIPSE trial, which showed A1C reductions of 0.64% in kids on Victoza plus metformin or insulin versus placebo.[1][2]
How Does It Work in Kids?
Victoza is a GLP-1 receptor agonist that boosts insulin release, slows digestion, and reduces appetite. In pediatric trials, kids received 0.3 mg to 1.8 mg daily subcutaneous injections, with dosing starting low to minimize side effects like nausea.[1][3]
What Do Clinical Studies Show?
The phase 3b ELLIPSE trial (NCT01559156) enrolled 52 adolescents (10-17 years) on metformin or insulin. After 26 weeks, Victoza lowered A1C more effectively than placebo and supported weight loss, with 63.6% achieving A1C below 7.5% versus 36.4% on placebo. Long-term data up to 52 weeks confirmed sustained benefits.[1][4]
Common Side Effects in Children
Kids report similar issues as adults: nausea (up to 24%), vomiting (15%), diarrhea (13%), and abdominal pain. Hypoglycemia risk rises with insulin use. Serious risks include pancreatitis, gallbladder issues, and thyroid tumors (black box warning). Growth monitoring is advised; no impact on height or bone density seen in trials.[1][2][5]
Who Should Avoid It?
Not for kids under 10, those with type 1 diabetes, or history of medullary thyroid carcinoma/MEN 2. Use caution with kidney issues or dehydration risk. Pregnancy category C; not studied in kids under 10 kg.[2][3]
How Does It Compare to Other Pediatric Options?
| Treatment | Age Approval | Key Differences |
|-----------|--------------|-----------------|
| Metformin | ≥10 years | First-line oral; no weight loss benefit |
| Insulin | Any age | Stronger glucose control but weight gain |
| Victoza | ≥10 years | Weight loss aid; injectable |
| Trulicity (dulaglutide) | ≥10 years (2022) | Weekly injection; similar efficacy[6] |
Victoza offers better weight control than insulin or metformin alone.[4]
Cost and Access for Pediatric Use
Monthly cost averages $900-$1,000 without insurance; patient assistance via Novo Nordisk covers eligible kids. Covered by most plans for approved pediatric use.[7]
Sources
[1]: FDA Label for Victoza
[2]: FDA Approval Announcement (2019)
[3]: Novo Nordisk Victoza Prescribing Info
[4]: NEJM ELLIPSE Trial (2017)
[5]: Drugs.com Victoza Side Effects
[6]: FDA Trulicity Approval (2022)
[7]: GoodRx Victoza Pricing