In a recent clinical trial, researchers discovered that a combination therapy involving insulin and investigational dapagliflozin could lead to improved health outcomes and reduced chronic kidney disease in adolescents with type 1 diabetes (T1D). This study focused on enhancing blood sugar control, kidney function, and minimizing weight gain.

Dr. Farid Mahmud from The Hospital for Sick Children expressed that adolescents who underwent this combined therapy experienced improvements in various symptoms typically associated with insulin-managed type 1 diabetes. This breakthrough could potentially pave the way for a novel early intervention strategy for the increasing number of teenagers diagnosed with type 1 diabetes.

Type 1 diabetes is an autoimmune disorder where the pancreas is unable to produce insulin. Early symptoms include fatigue, yeast infections, increased appetite, dry mouth, and unexplained weight loss. Advanced symptoms may involve stomach pain, nausea, vomiting, drowsiness, and rapid breathing. It is estimated that 1 in 4 or 5 children with type 1 diabetes experience diabetic ketoacidosis upon diagnosis, particularly in older children.

Past studies have shown similar positive outcomes in adults, prompting researchers to shift their focus to adolescents who are often underrepresented in clinical trials. Hormonal changes, psychological developments, and shared responsibilities are cited as barriers to research in this age group.

The trial was a double-blinded, randomized, placebo-controlled study conducted across multiple centers. Patients under 19 years old were treated with dapagliflozin or a placebo over a 16-week period. The primary endpoint was the measured glomerular filtration rate (GFR), with secondary outcomes including glycated hemoglobin A1c levels, adverse events, diabetes ketoacidosis, hypoglycemic events, and various infections, among others.

Results from the study involving 98 patients, of which 53% were female, indicated that dapagliflozin led to an 8.8 ml min⁻¹ 1.73 m⁻² reduction in measured GFR compared to the placebo. Patients with higher baseline GFR levels experienced more significant improvements. Additionally, HbA1c levels decreased by 0.47%, time in range increased by 9%, and body weight decreased by 2.8 kg.

Adverse events were comparable between the groups, with only one mild case of diabetic ketoacidosis reported in the study drug group. Researchers concluded that dapagliflozin, when used as an adjunct to insulin therapy, resulted in reduced mGFR, enhanced glycemic control, and was well-tolerated when combined with ketone testing and risk mitigation strategies.

Dr. Mahmud emphasized the promising treatment prospects this study unveils for adolescents with type 1 diabetes. By providing scientifically-backed options, this research aims to empower youth with diabetes to lead healthier lives.

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