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Lilly Announces Positive Results of Phase III Trials of Dulaglutide in Type 2 Diabetes



Lilly Announces Positive Results of Phase III Trials of Dulaglutide in Type 2
                                   Diabetes

Company Shares Top-line Results on Two Additional AWARD Trials, Both of which
Examined Efficacy Compared to Insulin Glargine

PR Newswire

INDIANAPOLIS, April 16, 2013

INDIANAPOLIS, April 16, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)
today announced positive top-line results of two additional Phase III AWARD
 trials for dulaglutide, an investigational, long-acting glucagon-like peptide
1 (GLP-1) receptor agonist being studied as a once-weekly treatment for type 2
diabetes.

Primary efficacy endpoints of non-inferiority to insulin glargine, as measured
by the reduction of hemoglobin A1c (HbA1c) levels at the 1.5 mg dose, were met
in two studies (AWARD-2 and AWARD-4).  Having met the primary endpoints,
superiority for HbA1c lowering was examined.  The dulaglutide 1.5 mg dose
demonstrated statistically superior reduction in HbA1c from baseline compared
to insulin glargine at 52 weeks in patients with type 2 diabetes on metformin
and glimeperide (AWARD-2).  The dulaglutide 1.5 mg dose in combination with
insulin lispro demonstrated statistically superior reduction in HbA1c from
baseline compared to insulin glargine in combination with insulin lispro at 26
weeks (AWARD-4).  

Across these two additional completed AWARD (Assessment of Weekly
AdministRation of LY2189265 in Diabetes) studies, the most frequently reported
adverse events were gastrointestinal-related. These adverse event findings are
consistent with prior studies of dulaglutide.

In October 2012, Lilly announced positive top-line results of three other
completed Phase III AWARD trials: AWARD-1, AWARD-3 and AWARD-5. Primary
efficacy endpoints, as measured by reduction in HbA1c at the 1.5 mg dose, were
met in all three. The five AWARD studies (1-5) will support registration
filings of dulaglutide.

"Dulaglutide, if approved, further advances our efforts to offer a broad
portfolio of therapies for people with diabetes, many of whom have unique
needs," said Enrique Conterno, president of Lilly Diabetes. "The results of
our Phase III dulaglutide trials are encouraging and we look forward to
sharing more details on the AWARD studies at upcoming scientific meetings."

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 in 2013.

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, is superior to placebo in reducing HbA1c from baseline at 26
weeks.

AWARD-2 was a 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,
conducted in 807 patients, was 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 was performed since the statistical
criterion for non-inferiority was 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, is non-inferior to
metformin in reducing HbA1c from baseline at 26 weeks.  Superiority testing
was performed since the statistical criterion for non-inferiority was
satisfied.

AWARD-4 was a 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, conducted
in 884 patients, was to evaluate whether dulaglutide 1.5 mg, dosed
once-weekly, in combination with insulin lispro, is non-inferior to insulin
glargine in combination with insulin lispro, in reducing HbA1c from baseline
at 26 weeks. Superiority testing was performed since the statistical criterion
for non-inferiority was 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, is non-inferior to sitagliptin in reducing HbA1c from
baseline at 52 weeks.  Superiority testing was performed since the statistical
criterion for non-inferiority was satisfied.

About Diabetes
Approximately 25.8 million Americans^1 and an estimated 371 million people^2
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.^3

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. P-LLY

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.

^1 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.

^2 International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet.
2012.

^3 International Diabetes Federation. Diabetes Atlas, 5th Edition: What is
Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on:
February 22, 2012.

Refer to: Candace Johnson, +1-317-755-9143, johnson_candace_a@lilly.com

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

SOURCE Eli Lilly and Company

Website: http://www.lilly.com
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