Could Your Child with Type 2 Benefit from Dapagliflozin or Saxagliptin?
In this clinical trial, researchers are studying the effectiveness of dapagliflozin and saxagliptin in children and adolescents with type 2 diabetes. While these drugs are different, one is an SGLT-2 inhibitor and one is a DPP-4 inhibitor, and both have shown to lower blood glucose in adults with type 2 diabetes. Learn more about how to get involved.
Clinical Trials Identifier: NCT03199053
Trial Name: Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients with Type 2 Diabetes Mellitus Aged 10 to Below 18 Years Old
Diabetes Type: Youth with type 2 diabetes
What is the trial testing?
This trial is evaluating the efficacy of two drugs, dapagliflozin (also known as Farxiga) and saxagliptin (also known as Onglyza) in 243 children (ages 10-18) with type 2 diabetes. While both of these drugs have already been approved for adults with type 2 diabetes and are widely used, they are not yet approved for those under the age of 18.
This 52-week research study is divided into two phases. The first 26-week phase will test short-term treatment while the final 26 weeks will test long-term treatment. The study will also include a follow-up telephone call on week 56 and a post-study visit at 104 weeks after starting the trial.
At the start of the trial, participants will be randomly split into three groups; they will receive either dapagliflozin (5 mg dose), saxagliptin (2.5 mg dose), or a placebo. These groups will remain the same until week 14. At week 14, those in either the dapagliflozin or the saxagliptin group will be randomly divided to receive either the same dose of their medicine or a higher dose. After this division, the following five groups will result: dapagliflozin (5 mg dose), dapagliflozin (10 mg dose), saxagliptin (2.5 mg dose), saxagliptin (5 mg dose), or a placebo.
The trial is primarily measuring change in baseline A1C at 26 weeks. The trial is also measuring changes in fasting plasma glucose at 26 weeks and the change in A1C and fasting plasma glucose at 52 weeks. It does not appear that this trial will be looking at Time in Range or continuous glucose monitor (CGM) values.
Why is this trial new and important?
Each of these drugs has a different mechanism to lower your blood glucose levels. Dapagliflozin is a SGLT-2 inhibitor, a drug class that blocks the process of reabsorbing glucose back into the blood when your kidneys filter your blood, causing glucose to be excreted through the urine. Saxagliptin, however, is a DPP-4 inhibitor, which means it stops the production of DPP-4, an enzyme (a natural chemical) that breaks down hormone GLP-1. GLP-1 causes the pancreas to produce insulin when your glucose increases at mealtime, so by increasing the amount of GLP-1, saxagliptin helps stimulate insulin production, leading to lower blood sugar.
Both dapagliflozin and saxagliptin have been helpful in the management of type 2 diabetes for the adult population. This trial could provide the evidence needed for these drugs to be approved for children and adolescents.
While the majority of children with diabetes have type 1 diabetes, the number of children with type 2 diabetes is on the rise. According to the SEARCH study, which tracks new cases of diabetes in people younger than 20, new cases of type 2 diabetes have increased by an average of 4.8% per year since 2002, raising the number of youths with type 2 diabetes to over 200,000.
Currently, the only FDA approved glucose-lowering medications for youth with type 2 diabetes are insulin, metformin, and three GLP-1 receptor agonists delivered by an injection: Bydureon BCise (ages 10-17), Victoza (10-17), and Saxenda, an obesity medication (12-17). The approval of either dapagliflozin or saxagliptin for this population would add much needed oral medicine options for healthcare professionals to prescribe to help this population manage their diabetes.
In addition, research shows that the earlier you get diabetes, the more prone you are to complications. These medicine options may be able to add protective benefits for this population – for example, dapagliflozin has been shown to reduce heart disease and chronic kidney disease risks, and protect against heart failure.
Trial length: 52 weeks
Trial location: 164 study locations around the world including in the US, Australia, Brazil, Canada, India, and Europe
Are you interested?
Your child may be eligible for this study if they:
Are between the ages of 10 and 18
Have been diagnosed with type 2 diabetes
Have a A1C between 6.5% and 10.5%
Are currently using metformin, insulin, or both to manage their diabetes (along with diet and exercise)
Are not pregnant or breastfeeding
Have not experience diabetic ketoacidosis (DKA) in the last six months
Have not used a sulfonylurea within the last eight weeks or a TZD, DPP-4 inhibitor, SGLT-2 inhibitor within the last 16 weeks
You can see a full list of eligibility and exclusion criteria here.
For more information: Please contact the AstraZeneca Clinical Study Information Center at 1-877-240-9479. You can also email firstname.lastname@example.org.