Findings from the groundbreaking ATTEMPT study were presented today, revealing that a low-dose SGLT2 inhibitor could be administered safely to children and adolescents with type 1 diabetes, thereby enhancing both kidney function and glycemic control. The study’s results were showcased at the 84th Scientific Sessions of the American Diabetes Association® (ADA) in Orlando, FL.
Type 1 diabetes affects approximately 352,000 children and teenagers under the age of 20. As the leading cause of kidney disease, diabetes necessitates proactive renal care to delay or prevent chronic kidney disease (CKD). Notably, around 65% of children with type 1 diabetes are at risk of developing kidney complications as they grow older.
The ATTEMPT (Adolescent Type 1 Diabetes Treatment with SGLT2i for hyperglycEMia & hyPerfilTration) trial is a pioneering, double-blinded, randomized, placebo-controlled study. It evaluated the effect of the SGLT2 inhibitor Dapagliflozin compared to a placebo, both used alongside insulin therapy in young individuals with type 1 diabetes. Over a 16-week period, the trial examined renal function through direct measurement of the glomerular filtration rate (GFR), glycemic control via HbA1c levels, and other safety outcomes in 98 participants.
The study's findings underscored that a low dose of Dapagliflozin safely improved kidney function and glycemic management in youths. The treatment led to a significant reduction in HbA1c by 0.48% (P=0.001) and effectively mitigated measures of GFR. Importantly, no significant differences in adverse events, elevated ketone levels, hypoglycemia, or genitourinary infections were found between the Dapagliflozin and placebo groups. There was, however, one mild case of diabetic ketoacidosis (DKA) in the Dapagliflozin group. While DKA rates remained low, there were more elevated blood ketone events in the Dapagliflozin group compared to the placebo group (P<0.001), highlighting the importance of the DKA Risk Mitigation Education strategy implemented during the study.
Dr. Farid Mahmud, the lead investigator from the University of Toronto, emphasized the significance of the study, stating, "This research offers a promising avenue for reducing the progression of kidney disease in young people with type 1 diabetes. Additionally, it provides valuable insights into optimizing diabetes management during a critical period marked by kidney disease progression and above-target A1c levels."
The study's authors noted that the protocols designed to mitigate the risk of diabetic ketoacidosis will be crucial in considering the broader clinical application of these drugs. They also mentioned that the ATTEMPT trial sets a precedent for future, longer-term studies to further explore the potential benefits of adjunctive therapy in managing type 1 diabetes.
Supported by JDRF Canada in partnership with the Canadian Institute of Health Research (CIHR) and Strategies for Patient Oriented Research (SPOR), the ATTEMPT study represents a significant step forward in the treatment of type 1 diabetes.
Dr. Mahmud presented these findings during a Late-Breaking Symposium at the ADA's Scientific Sessions. The ADA's annual meeting is the largest scientific gathering focused on diabetes research, prevention, and care, drawing over 11,000 professionals from around the globe to discuss the latest advancements and research in the field.
The ADA remains committed to combating the diabetes epidemic and improving the lives of those affected by diabetes through research, advocacy, and education.
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