Children and adolescents ages 10 to 18 who have been diagnosed with Type 2 diabetes are currently being recruited to participate in a study assessing the overall safety and tolerability of treatment with the diabetes drug Invokana.
Researchers aim to compare a group of pediatric patients with diabetes treated with Invokana to a group of similar patients treated with a placebo. Patients treated with Invokana will be given either 100 mg or 300 mg of Invokana. Effectiveness will be assessed after 26 weeks, and overall safety and tolerability will be assessed after 52 weeks.
The study is a randomized, double-blind, placebo-controlled project with the primary goal to determine if Invokana can improve participants’ HbA1c. Secondary measures include changes in fasting plasma glucose, body weight, body mass index (BMI), blood pressure, growth velocity, bone health, and kidney functions. The study is sponsored by Janssen Research & Development, a subsidiary of Johnson & Johnson. Invokana is made by Johnson & Johnson’s Janssen Pharmaceuticals.
Invokana was approved by the Food and Drug Administration (FDA) in 2013 to treat adults with Type 2 diabetes. It has been tested on patients with Type 1 diabetes but is not approved for this use. It is also not approved for pediatric patients.
Since Invokana hit the market, the FDA has either strengthened current warnings or added new warnings for health conditions including ketoacidosis, serious urinary infections, bone fractures, bone density loss, acute kidney injury, and leg and foot amputations. Currently, Janssen faces a growing number of lawsuits alleging the company did not adequately warn about Invokana side effects.