Findings Reveal Efficacy of Novel Inhaler to
Improve Glycemic Control for Patients with Type 1 Diabetes
ORLANDO,
Fla., June 22, 2024 /PRNewswire/ -- Today,
findings from INHALE-3, a pivotal trial examining the use of
inhaled insulin in adults with type 1 diabetes (T1D), were
announced, highlighting the potential of an alternative insulin
solution to enhance diabetes management. The results were presented
as a symposium at the 84th Scientific Sessions of the American
Diabetes Association® (ADA) in Orlando,
FL.
Type 1 diabetes affects 11.6% of the American population and
millions of individuals globally, requiring ongoing insulin therapy
to manage blood glucose levels. Traditional insulin delivery
methods include multiple daily injections or automated insulin
delivery systems. However, for some patients, there is a need for
new solutions to improve convenience, ease of use, and effective
glycemic management.
INHALE-3, a randomized trial, compared the efficacy of an
inhaled insulin regimen (Afrezza) plus degludec insulin (Tresiba®)
against usual care over 17 weeks at 19 centers in the U.S. The
trial included 123 adults with type 1 diabetes divided into two
groups: one receiving inhaled insulin (Afrezza) plus degludec
insulin, and the other continuing their usual care, which included
automated insulin delivery systems in about half or multiple daily
injections. The study's primary endpoint was a change in HbA1c
levels, a critical marker of long-term blood glucose control.
Secondary endpoints included changes in time-in-range and
hypoglycemia measured with continuous glucose monitoring and
patient-reported outcomes on insulin delivery satisfaction.
More participants using the inhaled insulin regimen experienced
significant improvements in HbA1c levels compared to those on usual
care. Notably, 21% of those on inhaled insulin had an HbA1c
improvement of greater than 0.5%, while this was seen in only 5% of
those with standard care. Furthermore, among participants who had
an HbA1c level greater than or equal to 7% at the start of the
study, 21% of those on inhaled insulin achieved the HbA1c goal of
less than 7% while no participants receiving standard care achieved
this HbA1c goal. Nineteen percent of participants who switched from
using an automated insulin delivery system to using inhaled insulin
plus degludec achieved an HbA1c improvement greater than 0.5%. In
contrast to these positive findings, the study found that the
insulin regimen with inhaled insulin and degludec was not for
everyone: 26% of the patients in the inhaled insulin group had a
worsening of HbA1c greater than 0.5% compared with 3% with standard
care. Importantly, over half of the study participants wished to
continue the inhaled insulin after the study completion.
"The INHALE-3 study's findings will impact diabetes management
by providing healthcare providers and patients with an alternative
insulin delivery method," said Irl B.
Hirsch, MD, University of
Washington, and lead author of the study. "These results
will assist in better informing clinical decisions and tailoring
treatment plans to individual patient needs, potentially improving
adherence, patient satisfaction, and overall outcomes."
Building on the promising results of INHALE-3, further research
will focus on the impact of inhaled insulin on a broader patient
population, including pediatrics and pregnancy. These studies aim
to reinforce the role of inhaled insulin in comprehensive diabetes
care.
Research presentation details:
Dr. Hirsch will present the findings at the following
symposium:
- Symposium: The Efficacy and Safety of Inhaled Insulin Used with
Insulin Degludec Compared with Automated Insulin Delivery or
Multiple Daily Insulin Injections in Adults with Type 1 Diabetes—
Results of the INHALE-3 Randomized Trial (Mannkind)
- Presented on Saturday, June 22,
2024 at 8:00 AM EDT.
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