SGLT2 Inhibitors for Teens With Type 1 Diabetes
By Eugenia Yun
A U.S. clinical trial is recruiting adolescents between the ages of 12 and 18 with type 1 diabetes who are willing to add an SGLT2 inhibitor to their treatment regimen. The study will evaluate the effect of the SGLT2 inhibitor on kidney health compared with a placebo.
Clinical Trials Identifier: NCT04333823
Trial Name: Adolescent Type 1 Diabetes Treatment With SGLT2i for hyperglycEMia & hyPerfilTration Trial (ATTEMPT)
Diabetes Type: Adolescents with type 1 diabetes
Trial Sponsor: The Hospital for Sick Children
What is the trial testing?
The ATTEMPT trial is a 16-week study evaluating the effect of treatment with dapagliflozin, an SGLT2 inhibitor, on kidney function in adolescents with type 1 diabetes compared with a placebo. Estimated enrollment is 100 participants, and they will be randomly assigned 1:1 to either the treatment group or placebo group. The treatment group will be given dapagliflozin 5 mg by mouth once a day for 16 weeks in addition to insulin therapy. The placebo group will be given a sugar pill manufactured to mimic the dapagliflozin tablet for 16 weeks, along with insulin therapy.
The primary goal of this study is to compare the change in glomerular filtration rate (a measure of kidney function) from the start of the trial through the end of 16 weeks between the two groups. Secondary goals are to compare changes in A1C, side effects of treatment, any occurrences of diabetic ketoacidosis (DKA), and changes in weight.
Why is this trial new and important?
Diabetes is a leading cause of kidney disease in both adults and children; almost all people living with type 1 diabetes experience changes in their kidney function within two to five years of diagnosis. Studies have found that rates of both type 1 diabetes and kidney disease in children are on the rise. SGLT2 inhibitors are a class of drugs that have been shown to protect the kidneys in adults with type 2 diabetes. However, they are not currently FDA-approved for either adults or adolescents with type 1 diabetes.
Trial Length: 16 weeks
Trial Locations: This is a multicenter study with one location in Colorado, USA, and two locations in Ontario, Canada. Click here to see a list of participating locations.
Are you interested?
Your child may be eligible to participate in this trial if that child:
Has been diagnosed with type 1 diabetes for at least 12 months
Is 12 to 18 years old
Has an A1C between 7% and 10%, though children with A1C levels outside this range may be considered
Is on insulin therapy
See a full list of inclusion/exclusion criteria here.