In QWINT-2, efsitora helped adults naïve to
insulin therapy currently using and not using GLP-1 receptor
agonists achieve an A1C below 7%
Detailed results were published in The New
England Journal of Medicine and simultaneously presented at the
European Association for the Study of Diabetes (EASD) Annual
Meeting 2024
INDIANAPOLIS, Sept. 10,
2024 /PRNewswire/ -- Eli Lilly and Company (NYSE:
LLY) today announced detailed results from the QWINT-2 phase 3
trial evaluating once-weekly insulin efsitora alfa (efsitora)
compared to once-daily insulin degludec in adults with type 2
diabetes using insulin for the first time (insulin naïve). The data
were published in The New England Journal of Medicine (NEJM)
and simultaneously presented today at the European Association for
the Study of Diabetes (EASD) Annual Meeting 2024.
In the trial, efsitora met the primary endpoint of non-inferior
A1C reduction. For the efficacy estimand1,2,
efsitora reduced A1C by 1.34% compared to 1.26% for insulin
degludec resulting in an A1C of 6.87% and 6.95%
respectively3 at 52 weeks.
Additionally, participants taking efsitora achieved 45 minutes
more time in range4 per day, a key secondary
endpoint, without additional time in hypoglycemia (glucose <54
mg/dL) in comparison to insulin degludec for the efficacy
estimand.
"Traditionally, basal insulins are dosed once a day — a
treatment schedule that can make compliance difficult for a
significant portion of people living with type 2 diabetes," said
Carol Wysham, M.D., clinical
professor of medicine at the University of
Washington School of Medicine. "Efsitora has the potential
to address treatment burden and improve adherence — all while
lowering A1C. These results can make a significant impact for
people living with type 2 diabetes looking for a once-weekly option
that provides similar outcomes as daily insulins."
Full Results
QWINT-2 Study:
Primary and Secondary Endpoints
|
|
Efficacy
Estimand
|
Treatment-Regimen
Estimand5
|
Primary Endpoint –
A1C Reduction (Resulting A1C) at Week 52
|
Efsitora
|
-1.34%
(6.87%)
|
-1.26%
(6.97%)6
|
Degludec
|
-1.26%
(6.95%)
|
-1.17%
(7.05%)7
|
Secondary Endpoint –
A1C Reduction in Participants using GLP-1s (Resulting A1C) at Week
52
|
Efsitora
|
-1.30%
(6.90%)
|
-1.26%
(6.96%)
|
Degludec
|
-1.28%
(6.92%)
|
-1.19%
(7.02%)
|
Secondary Endpoint –
A1C Reduction in Participants not using GLP-1s (Resulting A1C) at
Week 52
|
Efsitora
|
-1.38%
(6.85%)
|
-1.26%
(6.97%)
|
Degludec
|
-1.23%
(6.99%)
|
-1.15%
(7.08%)
|
Secondary Endpoint –
Percent Time in Range During the 4 Weeks Prior to Week
52
|
Efsitora
|
68.86 %
|
64.27 %
|
Degludec
|
65.75 %
|
61.18 %
|
"For the past century, we've been searching for the next
scientific breakthrough that would alleviate the complexity that
comes with starting insulin treatment," said Jeff Emmick,
M.D., Ph.D., senior vice president, product development,
Lilly. "With these results, we believe we're headed towards a
future where people with type 2 diabetes who use basal insulin
can achieve their desired results with a simple treatment option
like efsitora."
In the trial, efsitora demonstrated a safety profile similar to
daily insulins. There were no severe hypoglycemic events reported
during treatment with efsitora compared to six reported with
insulin degludec. Overall hypoglycemia rates in the study were low,
with estimated combined rates of severe or clinically significant
(blood glucose <54 mg/dL) hypoglycemic events per patient-year
of exposure of 0.58 with efsitora vs. 0.45 with insulin degludec.
Estimated combined rates of severe or clinically significant
nocturnal hypoglycemic events per patient-year of exposure were
0.08 with both efsitora and insulin degludec. Additionally, rates
of hypoglycemia were similar among people currently using GLP-1s
and those not using GLP-1s. Adverse events were similar between
treatment groups in the trial.
Detailed results for QWINT-5 are also being presented at EASD
and simultaneously published in The Lancet.
About the QWINT clinical trial program
The QWINT phase
3 global clinical development program for insulin efsitora alfa
(efsitora) in diabetes began in 2022 and has enrolled more than
4,000 people living with type 1 or type 2 diabetes across five
global registration studies.
QWINT-2 (NCT05362058) was a parallel-design, open-label,
treat-to-target, randomized controlled clinical trial comparing the
efficacy and safety of efsitora as a once-weekly basal insulin to
insulin degludec for 52 weeks in insulin-naïve adults with type 2
diabetes. The trial randomized 928 participants across the U.S.,
Brazil, Canada, China, Czechia (Czech Republic), Germany, Greece, Japan, Korea, Mexico and Puerto
Rico to receive efsitora once weekly or insulin degludec
once daily administered subcutaneously. The primary objective of
the trial was to demonstrate non-inferiority in reducing A1C at
week 52 with efsitora compared to insulin degludec. The trial was
also designed to assess efficacy and safety for patients using and
not using GLP-1 receptor agonists.
About insulin efsitora alfa
Insulin efsitora alfa
(efsitora) is a once-weekly basal insulin, a fusion protein that
combines a novel single-chain variant of insulin with a
human IgG2 Fc domain. It is specifically designed for
once-weekly subcutaneous administration, and with its low
peak-to-trough ratio, it has the potential to provide more stable
glucose levels (less glucose variability) throughout the week.
Efsitora is in phase 3 development for adults with type 1 and 2
diabetes.
About Lilly
Lilly is a medicine company turning science into healing to make
life better for people around the world. We've been pioneering
life-changing discoveries for nearly 150 years, and today our
medicines help more than 51 million people across the globe.
Harnessing the power of biotechnology, chemistry and genetic
medicine, our scientists are urgently advancing new discoveries to
solve some of the world's most significant health challenges:
redefining diabetes care; treating obesity and curtailing its most
devastating long-term effects; advancing the fight against
Alzheimer's disease; providing solutions to some of the most
debilitating immune system disorders; and transforming the most
difficult-to-treat cancers into manageable diseases. With each step
toward a healthier world, we're motivated by one thing: making life
better for millions more people. That includes delivering
innovative clinical trials that reflect the diversity of our world
and working to ensure our medicines are accessible and affordable.
To learn more, visit Lilly.com and Lilly.com/news, or follow
us on Facebook, Instagram and LinkedIn. P-LLY
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking
statements (as that term is defined in the Private Securities
Litigation Reform Act of 1995), including statements about insulin
efsitora alfa as a potential treatment for people with type 2
diabetes and the timeline for future readouts, presentations, and
other milestones relating to insulin efsitora alfa and its clinical
trials, and reflects Lilly's current beliefs and expectations.
However, as with any pharmaceutical product, there are substantial
risks and uncertainties in the process of drug research,
development, and commercialization. Among other things, there is no
guarantee that planned or ongoing studies will be completed as
planned, that future study results will be consistent with study
results to date, that insulin efsitora alfa will prove to be a safe
and effective treatment for type 2 diabetes, that insulin efsitora
alfa will receive regulatory approval, or that Lilly will execute
its strategy as expected. For further discussion of these and other
risks and uncertainties that could cause actual results to differ
from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q
filings with the United States Securities and Exchange Commission.
Except as required by law, Lilly undertakes no duty to update
forward-looking statements to reflect events after the date of this
release.
1 The efficacy estimand represents the treatment
effect had all participants adhered to the study drug without
initiating rescue therapy for persistent severe hyperglycemia.
2 95% CI for treatment difference (-0.22% to
0.06%).
3 From a baseline A1C of 8.21% for efsitora and
8.23% for insulin degludec.
4 Blood glucose 70-180 mg/dL.
5 Treatment-regimen estimand represents the efficacy
irrespective of adherence to the investigational medicine or
introduction of rescue therapy for persistent severe
hyperglycemia.
6 From a baseline A1C of 8.21% for efsitora and
8.24% for insulin degludec.
7 95% CI for treatment difference (-0.22%
to 0.04%).
Refer to:
|
Niki Smithers;
smithers_niki@lilly.com, 317-358-9074 (Media)
|
|
Joe
Fletcher; jfletcher@lilly.com, 317-296-2884
(Investors)
|
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SOURCE Eli Lilly and Company