Jardiance and Synjardy Approved for Kids Aged Ten and Up

Parents of kids with type 2 diabetes will be relieved to know that two additional drugs have just received FDA approval for children over the age of 10.

Newly Approved Diabetes Drugs

The US Food and Drug Administration (FDA) announced in June 2023, the approval of Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) for type 2 diabetes in children over the age of 10.¹ While the FDA has approved over 35 drugs to treat adult type 2 diabetes, until now, kids have only had access to metformin.

In a press release by the FDA, Michelle Carey, M. D., M.P.H., associate director for therapeutic review for the Division of Diabetes, Lipid Disorders and Obesity explains, “Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children.”¹

The approval of Jardiance and Synjardy comes as a result of a 2023 study published in The Lancet Diabetes and Endocrinology. Harvard Medical school researchers discovered that Jardiance lowers blood sugar levels in children after 26 weeks, compared to a placebo medication.²

Diabetes Danger  

Type 2 diabetes develops when the body cannot control blood sugar levels because it does not create or use insulin properly. If you have too much sugar in your blood, it can damage your blood vessels. Lack of oxygen supply as result of damaged vessels starves delicate body parts, such as the eyes, toes, kidneys, heart, and brain. Left uncontrolled, diabetes can lead to kidney failure, heart disease, vision loss and stroke amongst other complications.³

Risk Factors for Diabetes

Type 2 diabetes is a condition that usually develops over a long period, and is typically associated with high body fat percentages. Obesity is the leading risk factor for developing type 2 diabetes. However, a genetic component contributes to how easily type 2 diabetes or insulin resistance creeps up on us.³

People genetically inclined to develop type 2 diabetes are at greater risk of diabetes at all ages. In some populations, such as those of Asian and African-Carribbean descent, diabetes is triggered at a lower body fat threshold than others.⁴ Some researchers speculate that this results from famines in the relatively recent past. Starvation of pregnant women can cause genetic changes in the unborn child that they will then pass on to their kids.⁵

Diabetes in Kids

Since type 2 diabetes usually takes many years to develop and is more often sparked by gaining a significant amount of fat, childhood type 2 diabetes is rare. In Canada, the rate of occurrence for childhood type 2 diabetes is 1.84/100,000, and it appears to be most commonly inherited within families.^6,9,10 This suggests a strong genetic component besides contributions from lifestyle.  

To develop Type 2 diabetes at such a young age, children have undergone an accelerated process. The consequence of this is a risk that the negative health effects may also be expedited.  If not carefully managed, diabetes can lead to loss of feeling in the limbs, loss of vision, kidney disease, heart disease, stroke and death.³

 Controlling Diabetes

Diet and exercise plans are the first line of treatment for type 2 diabetes. Reducing the quantity of sugar you eat and increasing the glucose you burn through exercise, results in lower blood sugar levels.

Diet and exercise programs can be highly effective at treating type 2 diabetes. They can even reverse type 2 diabetes when followed correctly. However, if individuals do not maintain diet and exercise changes, type 2 diabetes will return. Therefore, the individual must make lifelong lifestyle changes, which can be hard to keep.

Unfortunately for kids, this isn’t always a realistic treatment approach. Given that childhood type 2 diabetes develops faster than in adults, using medications to control blood sugar levels while they try to reduce their body mass could give these kids a better chance at recovery.  
The FDA has approved over 35 drugs approved for treating type 2 diabetes in adults. With the exception of metformin, most of these drugs are ineffective in children. In fact, metformin only works for roughly half of kids.^7,9,10

Jardiance Reduces HbA1C scores in Kids

The aim of the study was to test whether Jardiance could reduce blood sugar levels better than a placebo. Health care providers measure our average blood glucose levels using a haemoglobin A1C score. They take a small amount of blood over a few months and test how much glucose is present. The average is then given as your A1C score. A normal A1C score would be below 5.7%. A pre diabetes score would be 5.7-6.4% while a diabetic A1C level would be a score of more than 6.5%.⁸

Researchers tested Jardiance in 157 patients between the ages of 10–17 years. In the experiment, children were given either Jardiance or a placebo for 26 weeks in an outpatient setting.

After 26 weeks, the study found that the A1C score of children who received a placebo had increased an average 0.7%, while those taking Jardiance had reduced their readings 0.2%. This evened out to show that on average Jardiance reduced haemoglobin A1C scores 0.8%. This looks like a tiny change, but an A1C reduction of 0.8% could take a patient from a diabetic reading to a normal reading. This study did not compare Jardiance to metformin.² 

How does Empagliflozin work?

Jardiance and Synjardy both contain the active ingredient empagliflozin. The aim of these drugs is to get the extra sugar out of the body fast when there is too much for the body to handle. Empagliflozin works in the kidneys, increasing the amount of sugar expelled in the urine. In contrast, metformin reduces the sugar in the blood through action on the intestines and liver. Synjardy includes both empagliflozin and metformin and works in the intestine, liver and kidneys. ¹

Because it works on the gut, metformin can be harsh on the digestive system. The most common side effects of metformin are nausea, diarrhea and upset stomach. Since empagliflozin does not affect the gut, it is gentler on a young digestive system. The most common side effects of empagliflozin are low blood sugar, urinary tract infections, and fungal infections in females.²

Alternatives to Metformin

Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) are now FDA approved for treating type 2 diabetes in tweens and teens. Metformin was the only drug approved to treat type 2 diabetes in children 10–17 years. When type 2 diabetes is left untreated, teens face the risk of developing premature kidney disease, heart disease, stroke, and death. Now, doctors have alternative treatment options for teens unable to take Metformin due to its side effects.
 
Kerri Z. Delaney
  

References
 

1. Food and Drug Administration. FDA Approves New Class of Medicines to Treat Pediatric Type 2 Diabetes. Published June 20, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-new-class-medicines-treat-pediatric-type-2-diabetes
2. Laffel LM, Danne T, Klingensmith GJ, et al. Efficacy and safety of the SGLT2 inhibitor empagliflozin versus placebo and the DPP-4 inhibitor linagliptin versus placebo in young people with type 2 diabetes (DINAMO): a multicentre, randomised, double-blind, parallel group, phase 3 trial. The Lancet Diabetes & Endocrinology. 2023;11(3):169–181. doi: 10.1016/S2213-8587(22)00387-4
3. Type 2 Diabetes. National Institute of Diabetes and Digestive and Kidney Diseases.U.S Department of Health and Human Services. Updated May 2017. Accessed November 2023. https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes/type-2-diabetes
4. Pan WH, Yeh WT. How to define obesity? Evidence-based multiple action points for public awareness, screening, and treatment: an extension of Asian-Pacific recommendations. Asia Pac J Clin Nutr. 2008;17(3):370-374.https://apjcn.nhri.org.tw/server/APJCN/17/3/370.pdf
5. Thurner S, Klimek P, Szell M, et al. Quantification of excess risk for diabetes for those born in times of hunger, in an entire population of a nation, across a century. Proc Natl Acad Sci U S A. 2013;110(12):4703-4707. doi:10.1073/pnas.1215626110
6. Diabetes in Canada. Government of Canada; 2023. Accessed November 2023. https://www.canada.ca/en/public-health/services/publications/diseases-conditions/diabetes-canada-highlights-chronic-disease-surveillance-system.html
7. Tamborlane W, Shehadeh N. Unmet Needs in the Treatment of Childhood Type 2 Diabetes: A Narrative Review. Adv Ther. 2023;40(11):4711-4720. doi:10.1007/s12325-023-02642-7
8.    The A1C Test & Diabetics. National Institue of Diabetes and Digestive and Kidney Diseases. Type 2 Diabetes.Reviewed April 2018. Accessed November 2023. https://www.niddk.nih.gov/health-information/diagnostic-tests/a1c-test
9.     Constadina Panagiotopoulos MD, FRCPC, Stasia Hadjiyannakis MD, FRCPC, Mélanie Henderson MD, FRCPC, PhD. Type 2 Diabetes in Children and Adolescents. https://www.diabetes.ca/health-care-providers/clinical-practice-guidelines/chapter-35#panel-tab_FullText
10.     Pulgaron ER, Delamater AM. Obesity and Type 2 Diabetes in Children: Epidemiology and Treatment. Curr Diab Rep. 2014;14(8):508. doi:10.1007/s11892-014-0508-y