Date: October 22, 2012
For Release: October 22, 2012
Refer to: Kelley Murphy, +1
317.701.4007, kmurphy@lilly.com
Candace Johnson, +1-317-755-9143,
johnson_candace_a@lilly.com
Lilly Diabetes Announces Positive Results of Phase III
Trials of Dulaglutide in Type 2 Diabetes
Company Shares Top-line Results on Three Completed AWARD Trials
Indianapolis, October 22, 2012 - Eli Lilly and Company (NYSE:
LLY) today announced positive top-line results of three completed
Phase III AWARD trials for dulaglutide, an investigational,
long-acting glucagon-like peptide 1 (GLP-1) analog being studied as
a once-weekly treatment for type 2 diabetes. Primary efficacy
endpoints, as measured by reduction in hemoglobin A1c (HbA1c) at
the 1.5 mg dose, were met in three studies (AWARD-1, AWARD-3 and
AWARD-5). Having met the primary endpoints, superiority for HbA1c
lowering was examined, and both doses of dulaglutide (0.75mg and
1.5mg) demonstrated statistically superior reduction in HbA1c from
baseline compared to: exenatide twice-daily injection at 26 weeks
(AWARD-1); metformin at 26 weeks (AWARD-3); and sitagliptin at 52
weeks (AWARD-5).
Across the three completed AWARD studies, the most frequently
reported adverse events were gastrointestinal-related. These
adverse event findings are consistent with prior studies of
dulaglutide.
There are a number of additional AWARD (Assessment of Weekly
AdministRation of LY2189265 in Diabetes) trials ongoing. Two of
these studies for submission, AWARD-2 and AWARD-4, will conclude in
the next few months.
"We're very encouraged by the results to date from our Phase III
dulaglutide trials and are pleased to be one step closer to
offering a new GLP-1 treatment option for type 2 diabetes," said
Enrique Conterno, President,
Lilly Diabetes. "People with
diabetes require different treatment options based on their
individual needs. That's why Lilly Diabetes is committed to
delivering a broad, comprehensive portfolio of therapies."
Lilly plans to present detailed data from the AWARD studies at
scientific meetings in 2013 and 2014. The company expects to submit
dulaglutide to regulatory authorities during 2013 with the timing
of regulatory submission in the United
States dependent upon satisfactory completion of U.S. Food
and Drug Administration requirements for assessment of
cardiovascular risk.
About the AWARD (Assessment of Weekly AdministRation of
LY2189265 in Diabetes) studies planned to support registration
filings.
AWARD-1 was a randomized, 52-week, placebo-controlled comparison
of the effects of dulaglutide and exenatide on glycemic control in
patients with type 2 diabetes on metformin and pioglitazone. The
primary objective of the study, conducted in 978 patients, was to
evaluate whether dulaglutide 1.5mg, dosed once-weekly, was superior
to placebo in reducing HbA1c from baseline at 26 weeks.
AWARD-2 is an ongoing randomized, 78-week, open-label comparison
of the effects of dulaglutide and insulin glargine on glycemic
control in patients with type 2 diabetes on metformin and
glimepiride. The primary objective of the study is to evaluate
whether dulaglutide 1.5 mg, dosed once-weekly, is non-inferior to
insulin glargine in reducing HbA1c from baseline at 52 weeks.
Superiority testing will be performed if the statistical criterion
for non-inferiority is satisfied.
AWARD-3 was a randomized, 52-week, double-blind comparison of
the effects of dulaglutide and metformin on glycemic control in
patients with early type 2 diabetes. The primary objective of the
study, conducted in 807 patients, was to evaluate whether
dulaglutide 1.5 mg, dosed once-weekly, was non-inferior to
metformin in reducing HbA1c from baseline at 26 weeks. Superiority
testing was performed as the statistical criterion for
non-inferiority was satisfied.
AWARD-4 is an ongoing randomized, 52-week, open-label comparison
of the effects of dulaglutide and insulin glargine, both in
combination with insulin lispro, in patients with type 2 diabetes.
The primary objective of the study is to evaluate whether
dulaglutide 1.5 mg, dosed once-weekly, is non-inferior to insulin
glargine in reducing HbA1c from baseline at 26 weeks. Superiority
testing will be performed if the statistical criterion for
non-inferiority is satisfied.
AWARD-5 was a randomized, 104 week, double-blind,
placebo-controlled comparison of the effects of dulaglutide and
sitagliptin on glycemic control in patients with type 2 diabetes on
metformin. The primary objective of the study, conducted in 1,098
patients, was to evaluate whether dulaglutide 1.5 mg, dosed
once-weekly, was non-inferior to sitagliptin in reducing HbA1c from
baseline at 52 weeks. Superiority testing was performed as the
statistical criterion for non-inferiority was satisfied.
About Diabetes
Approximately 25.8 million Americans and an estimated 366
million people worldwide have type 1 and type 2 diabetes. Type 2
diabetes is the most common type, accounting for an estimated 90 to
95 percent of all diabetes cases. Diabetes is a chronic disease
that occurs when the body either does not properly produce, or use,
the hormone insulin.
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when
Lilly introduced the world's first commercial insulin. Today Lilly
works to meet the diverse needs of people with diabetes through
research and collaboration, a broad and growing product portfolio
and a continued commitment to providing real solutions - from
medicines to support programs and more - to make lives better. For
more information, visit www.lillydiabetes.com.
About Eli Lilly and Company (NYSE: LLY)
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of pharmaceutical products by applying the latest
research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered
in Indianapolis, Ind., Lilly
provides answers - through medicines and information - for some of
the world's most urgent medical needs. Additional information about
Lilly is available at www.lilly.com.
# # #
This press release contains forward-looking statements about
dulaglutide that are based on Lilly's current expectations. Actual
results could differ materially from these expectations. There are
significant risks and uncertainties in the process of drug
development and commercialization. There can be no guarantee that
future study results and patient experience will be consistent with
the study findings to date. There can also be no guarantee that
dulaglutide will be submitted to regulatory authorities in 2013,
that it will receive the necessary clinical and manufacturing
regulatory approvals, or that it will prove to be commercially
successful. For further discussion of these and other risks and
uncertainties that could cause actual results to differ from
Lilly's expectations, please see the company's latest Forms 10-K
and 10-Q filed with the U.S. Securities and Exchange Commission.
Except as required by law, the company undertakes no duty to update
forward-looking statements.
- 4 -
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
U.S.A.
Centers for Disease Control. National Diabetes Fact Sheet-2011.
Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf.
Accessed on: February 22, 2012.
International Diabetes Federation. Diabetes Atlas, 5th Edition:
Fact Sheet. 2011.
International Diabetes Federation. Diabetes Atlas, 5th Edition:
What is Diabetes?
http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on:
February 22, 2012.
