SGLT2i Shown as Potential Solution to Help
Manage Renal Complications and Improve Glycemic Control for Young
Individuals Living with Type 1 Diabetes
ORLANDO,
Fla., June 24, 2024 /PRNewswire/ -- Today,
findings from the ATTEMPT study, showed that a low-dose of SGLT2
inhibitor could safely be given to youth and adolescents with type
1 diabetes to improve kidney function and glycemic management.
ATTEMPT is the first of its kind, landmark trial designed to
evaluate the effectiveness of SGLT2 inhibitors to optimize diabetes
control and prevent early subclinical kidney complications in an
at-risk pediatric population with type 1 diabetes. The results were
presented as a Late-Breaking Symposium at the 84th
Scientific Sessions of the American Diabetes Association® (ADA) in
Orlando, FL.
Type 1 diabetes impacts 352,000 children and adolescents younger
than an age of 20 years. Diabetes is the number one cause of kidney
disease, highlighting the need for renal precautions and
interventions among individuals with diabetes. About 65% of
children with type 1 diabetes may experience kidney complications
which can lead to chronic kidney disease (CKD) as they age.
ATTEMPT (The Adolescent Type 1 Diabetes Treatment with SGLT2i
for hyperglycEMia & hyperfiltration Trial) is a double-blinded,
randomized, placebo-controlled trial that evaluated the impact
of the SGLT2 inhibitor, Dapagliflozin, versus a placebo in
combination with insulin therapy in adolescents with type 1
diabetes. Over a 16-week monitoring period, this trial assessed
detailed renal mechanistic evaluations with direct measurement of
glomerular filtration rate (GFR), glycemic control (HbA1c), and
safety outcomes in 98 participants with type 1 diabetes. As a
result, the ATTEMPT trial provides essential information in
establishing a framework for young adolescents to evaluate key
physiologic, mechanistic, and metabolic outcomes when using SGLT2i
alongside insulin in type 1 diabetes.
The study demonstrated that a low dose of SGLT2 inhibitor could
safely be given to youths and adolescents to improve kidney
function as well as improve glycemic management. Treatment with low
dose Dapagliflozin attenuated direct measures of GFR and was
associated with a significant decline in HbA1c of 0.48% (P=0.001).
No significant differences in the proportion of participants
who experienced adverse events, elevated ketone levels,
hypoglycemia and genitourinary tract infections in the
Dapagliflozin vs Placebo groups were seen. A single case (N=1) of
mild DKA was seen in the Dapagliflozin group. While rates of DKA
were low, a greater number of elevated blood ketone events
≥0.6mmol/L were seen in the Dapagliflozin group (n=106) vs Placebo
group (n=62) (P<0.001), emphasizing the patient centered DKA
Risk Mitigation Education strategy operationalized during the
study.
"This study paves the way for us to evaluate treatments that can
reduce kidney disease progression for those with type 1 diabetes,"
said Farid Mahmud, MD, University of Toronto, lead investigator of study.
"These findings also give us meaningful insights as we look how we
optimize diabetes management in youth and young adults during a
challenging period associated with kidney disease progression and
above-target A1c."
The authors note the trial was designed with protocols to
successfully mitigate the risk for diabetic ketoacidosis, a
risk that will need to be considered before these drugs can be
widely used in clinical practice. They also state that the ATTEMPT
Trial paves the way for researchers to produce longer studies that
could help better understand additional benefits of adjunctive
therapy in type 1 diabetes.
The ATTEMPT Study was supported by JDRF Canada in partnership
with the Canadian Institute of Health Research (CIHR), Strategies
for Patient Oriented Research (SPOR).
Research presentation details:
Dr. Mahmud will present the findings at the following
symposium:
- Late- Breaking Symposium: Use of SGLT2i in Youth with Type 1
Diabetes—Results from ATTEMPT (The Adolescent Type 1 Diabetes
Treatment with SGLT2i for hyperglycEMia & hyPerfilTration
Trial)
- Session: Monday, June 24, 2024 at
3:15 – 4:15 PM ET
About the ADA's Scientific Sessions
The ADA's 84th Scientific Sessions, the world's largest
scientific meeting focused on diabetes research, prevention, and
care, will be held in Orlando, FL
on June 21-24. More than 11,000
leading physicians, scientists, and health care professionals from
around the world are expected to convene both in person and
virtually to unveil cutting-edge research, treatment
recommendations, and advances toward a cure for diabetes. Attendees
will receive exclusive access to thousands of original research
presentations and take part in provocative and engaging exchanges
with leading diabetes experts. Join the Scientific Sessions
conversation on social media using
#ADAScientificSessions.
About the American Diabetes Association
The American Diabetes Association (ADA) is the nation's leading
voluntary health organization fighting to bend the curve on the
diabetes epidemic and help people living with diabetes thrive. For
83 years, the ADA has driven discovery and research to treat,
manage, and prevent diabetes while working relentlessly for a cure.
Through advocacy, program development, and education we aim to
improve the quality of life for the over 136 million Americans
living with diabetes or prediabetes. Diabetes has brought us
together. What we do next will make us Connected for Life®. To
learn more or to get involved, visit us
at diabetes.org or call 1-800-DIABETES (1-800-342-2383).
Join the fight with us on Facebook (American Diabetes Association),
Spanish Facebook (Asociación Americana de la Diabetes), LinkedIn
(American Diabetes Association), Twitter (@AmDiabetesAssn), and
Instagram (@AmDiabetesAssn).
Contact:
Amy Robinson
arobinson@brgcommunications.com
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SOURCE American Diabetes Association