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Eli Lilly and Company

New Study Shows Exenatide Improves Blood Sugar Levels as Effectively as Insulin Glargine

Copenhagen, Denmark (ots/PRNewswire)

- Patients Taking Exenatide Lost Weight While Patients Taking
Insulin Glargine Gained Weight
Eli Lilly and Company (NYSE: LLY) and Amylin Pharmaceuticals, Inc.
(Nasdaq: AMLN) today announced results from a study indicating that
exenatide improves blood sugar levels as effectively as insulin
glargine (Lantus(R), Sanofi Aventis) for people with type 2 diabetes
failing to achieve acceptable blood sugar control on metformin or a
sulfonylurea, two common oral diabetes medications. This is the third
study demonstrating that exenatide can control blood sugar as
effectively as insulin.(1)(2)
In this 32-week cross-over study, each patient received treatment
with exenatide and insulin glargine for 16 weeks. Patients
experienced similar reductions in hemoglobin A1C (HbA1C), or blood
sugar levels, when treated with exenatide or insulin glargine. Forty
percent of study participants reached target HbA1C of 7 percent or
less when treated with exenatide compared to forty-one percent when
they were treated with insulin glargine. Less than 7 percent is the
target for good glucose control as recommended by American Diabetes
Association (ADA). Twenty-four percent of patients on exenatide
achieved target HbA1C of less than 6.5 percent compared with 14
percent when treated with glargine. The International Diabetes
Federation (IDF) recommends a target HbA1C of 6.5 percent or less.
These findings were presented at the 42nd annual meeting of the
European Association of the Study of Diabetes (EASD) in Copenhagen,
Denmark.
Exenatide treatment also resulted in an average reduction in body
weight. After taking exenatide, patients on exenatide lost an average
of 1.95 kilograms (4.3 pounds), but after taking insulin glargine,
patients gained an average of 0.35 kilograms (0.77 pounds). In
addition, exenatide significantly reduced postprandial glucose levels
(peak levels after meals) compared to insulin glargine. Exenatide and
insulin glargine treatment resulted in similar rates of hypoglycemia
(low blood sugar) with a sulfonylurea, a therapy known to cause
hypoglycemia when used alone. In combination with metformin, patients
receiving exenatide treatment experienced fewer cases of hypoglycemia
than when they were treated with insulin glargine.
"The results of this study demonstrate that exenatide could
potentially be an effective treatment option for the management of
type 2 diabetes patients who cannot control their blood sugar using
oral medications," said Professor Anthony Barnett of the University
of Birmingham and Birmingham Heartlands Hospital in the United
Kingdom and a lead author of the study. "In addition to helping
patients lower their HbA1C as effectively as insulin glargine,
exenatide also helped patients lose weight -- an important factor in
the management of type 2 diabetes."
Exenatide is the first in a new class of medicines known as
incretin mimetics and was approved for use in the United States by
the U.S. Food and Drug Administration in April 2005 for the treatment
of type 2 diabetes. Exenatide is injected twice daily. The U.S. is
the first country that has received regulatory approval for
exenatide. In late 2005, Lilly submitted exenatide for approval in
the European Union.
Key Findings
A1C reduction:
-- Both treatments achieved similar HbA1C reductions. Exenatide
lowered HbA1C by 1.43 percent while insulin glargine lowered HbA1C by
1.41 percent.
-- When measured against the target HbA1C of less than or equal to
7 percent, 40 percent of patients achieved target HbA1C level of less
than or equal to 7 percent when treated with exenatide, compared to
41 percent when treated with insulin glargine.
-- When measured against the target HbA1C level of less than or
equal to 6.5 percent, 24 percent of patients receiving exenatide
achieved this level compared to 14 percent when receiving insulin
glargine.
Glucose measurements:
-- As measured by seven-point glucose monitoring, exenatide
reduced postprandial excursions, the rise of glucose after meals,
following breakfast and dinner.
-- The fasting blood glucose was significantly decreased from
baseline for both treatments (exenatide, 3.04 mmol/L; insulin
glargine, 4.17 mmol/L).
Weight change:
-- Weight loss in the exenatide arm: Patients treated with
exenatide experienced an average weight reduction of 1.95 kilograms
(4.3 pounds).
-- Weight gain in the insulin glargine arm: On average, patients
treated with insulin glargine gained 0.35 kilograms (0.77 pounds).
Hypoglycemia
-- Hypoglycemia occurred in a greater percentage of patients
treated with a sulfonylurea (30 percent exenatide, 35 percent insulin
glargine) compared with patients treated with metformin (3 percent
exenatide, 17 percent insulin glargine).
Other adverse events:
-- The most common adverse event for exenatide was nausea (33.1
percent for exenatide, 3.9 percent for insulin glargine), which was
generally mild-to-moderate and tended to decrease in frequency and
severity over time.
Study Design/Protocol
141 patients were enrolled in the 32-week, multi-center,
open-label, randomized, two-arm, cross-over trial. The trial was
designed to determine if exenatide can be used as safely and
effectively as insulin glargine in type 2 diabetes patients
inadequately treated with metformin or a sulfonylurea.
Study participants were randomized during two, 16-week treatment
periods. One group first received a dose of exenatide (5 micrograms
twice-a-day for first four weeks, then 10 micrograms twice-a-day for
12 weeks), in conjunction with metformin or a sulfonylurea, and then
crossed over to insulin glargine. The second group first received
insulin glargine (iterated using a treat-to-target algorithm to a
fasting blood glucose of less than or equal to 5.6 mmol/L) for 16
weeks, again with metformin or a sulfonylurea, and then crossed over
to exenatide. The average HbA1C at baseline was 8.9 percent.
About exenatide
Exenatide is the first incretin mimetic, a new class of drugs for
the treatment of type 2 diabetes. Exenatide exhibits many of the same
effects as the human incretin hormone glucagon-like peptide-1
(GLP-1). GLP-1, secreted in response to food intake, has multiple
effects on the intestine, liver, pancreas and brain that work in
concert to regulate blood sugar.(3)
About Incretin Mimetics
Incretin mimetics are a distinct class of treatment in the fight
against diabetes. An incretin mimetic works to mimic the
anti-diabetic or glucose-lowering actions of naturally occurring
human hormones called incretins. These actions include stimulating
the body's ability to produce insulin in response to elevated levels
of blood sugar, inhibiting the release of a hormone called glucagon
following meals, slowing the rate at which nutrients are absorbed
into the bloodstream and reducing food intake. Exenatide is the first
FDA-approved incretin mimetic.
About Diabetes
Diabetes affects an estimated 194 million adults worldwide(4) and
around 48.4 million in Europe.(5) Approximately 90 to 95 percent of
those are affected by type 2 diabetes, a condition characterized by
failure of the pancreatic beta cells to adequately respond to the
increased demands for insulin that occur as a result of
obesity-related insulin resistance.(6) Type 2 diabetes usually occurs
in adults over the age of 40, but is increasingly common in younger
people.(5) In virtually every developed society, diabetes is ranked
among the leading causes of blindness, renal failure and lower limb
amputation, as well as death through its effects on cardiovascular
disease (70-80 percent of people with diabetes die of cardiovascular
disease)(7). The calculated estimates of the costs of diabetes care
in Europe amount to 42.8 million International Dollars per year.(8)
About Lilly and Amylin
Through a long-standing commitment to diabetes care, Lilly
provides patients with breakthrough treatments that enable them to
live longer, healthier, and fuller lives. Since 1923, Lilly has been
the industry leader in pioneering therapies to help health care
professionals improve the lives of people with diabetes, and research
continues on innovative medicines to address the unmet needs of
patients.
Lilly, a leading innovation-driven corporation is developing a
growing portfolio of first-in-class and best-in-class pharmaceutical
products by applying the latest research from its own worldwide
laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, IN, Lilly provides
answers -- through medicines and information -- for some of the
world's most urgent medical needs.
Amylin Pharmaceuticals is a biopharmaceutical company committed to
improving lives through the discovery, development and
commercialization of innovative medicines. Amylin's research and
development activities leverage the company's expertise in metabolism
to develop promising therapies to treat diabetes, obesity and
cardiovascular disease. Amylin is located in San Diego, California
with over 1200 employees nationwide.
This press release contains forward-looking statements about
Amylin and Lilly. Actual results could differ materially from those
discussed or implied in this press release due to a number of risks
and uncertainties, including the risk that future clinical trials may
not replicate previous trial results; risks that exenatide may not
prove to be an important new therapeutic option, European approval
for exenatide or regulatory approval of additional indications for
exenatide may not be received or exenatide may be affected by
unexpected new data or technical issues. The potential for exenatide
may also be affected by government and commercial reimbursement and
pricing decisions, the pace of market acceptance and any issues
related to manufacturing and supply. These and additional risks and
uncertainties are described more fully in Amylin and Lilly's most
recently filed SEC documents such as their Quarterly Reports on Form
10-Q. Amylin and Lilly disclaim any obligation to update these
forward-looking statements.
P-LLY
REFERENCES
(1) Heine RJ, Van Gaal LF, Johns D, Mihm MJ, Widel MH, Brodows RG.
Exenatide versus insulin glargine in patients with suboptimally
controlled type 2 diabetes: A randomized trial. Annals of Internal
Medicine. 2005; 143(8):559-69.
(2) Nauck MA, Duran S, Kim D, Johns D, Festa A. Effects of
exenatide compared with twice-daily biphasic insulin aspart in
patients with type 2 diabetes using sulphonylurea and metformin. Data
disclosure at the 42nd annual meeting of the European Association of
the Study of Diabetes. September 14, 2006.
(3) Kolterman, O, Buse J, Fineman M, Gaines E, Heintz S, Bicsak T,
Taylor K, Kim D, Aisporna M, Wang Y, Baron A. Synthetic exendin-4
(exenatide) significantly reduces postprandial and fasting glucose in
subjects with type 2 diabetes. Journal of Clinical Endocrinology &
Metabolism. 2003; 88(7):3082-3089.
(4) The International Diabetes Federation Diabetes Atlas.
Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2
FD3-87B73F80BC22682A. Accessed April 12, 2005.
(5) The International Diabetes Federation, Prevalence / All
diabetes. Available
athttp://www.eatlas.idf.org/Prevalence/All_diabetes/.
(6) Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with
diet, sulfonylurea, metformin, or insulin in patients with type 2
diabetes mellitus: progressive requirement for multiple therapies
(UKPDS 49). JAMA. 1999; 281 (21):2005-2012.
(7) The International Diabetes Federation, Complications.
Available athttp://www.eatlas.idf.org/Complications/.
(8) The International Diabetes Federation, Diabetes Atlas, Second
edition. The Economic Impact of Diabetes. 2003: 186.
(Logo:  http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
            http://www.newscom.com/cgi-bin/prnh/20060610/AMYLINLOGO )

Contact:

Lilly - Derin Denham, +1-317-277-6749 (office), +1-317-370-1435
(mobile); or Amylin - Alice Bahner, +1-858-642-7272 (office),
+1-858-232-9072 (mobile) ; Photo: NewsCom:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO ,
http://www.newscom.com/cgi-bin/prnh/20060610/AMYLINLOGO , PRN Photo
Desk, photodesk@prnewswire.com

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