Copenhagen, Denmark (ots/PRNewswire)
- Patients on exenatide lost weight, while insulin aspart patients
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 biphasic
insulin aspart 30/70 (NovoMix 30(R), NovoNordisk) for people with
type 2 diabetes failing to achieve acceptable blood sugar control on
both metformin and a sulfonylurea, two common oral diabetes
medications. This long-term clinical trial is the second study
conducted at European clinical centers demonstrating that exenatide
can control blood sugar as effectively as insulin.(1)
During the one year (52-week) study, patients using exenatide
showed improvements in three important measures of blood glucose
control: fasting blood glucose, postprandial blood glucose, and
hemoglobin A1C (HbA1C). Exenatide treatment also resulted in an
average reduction in body weight.
Thirty-two percent of study participants using exenatide reached
target HbA1C of 7 percent or less. HbA1C measures a person's average
glucose level over a three-month period and is often used by health
care providers to assess blood glucose management. The American
Diabetes Association (ADA) recommends a target HbA1C of less than 7
percent. When measured against the International Diabetes Federation
(IDF) recommended target HbA1C of 6.5 percent or less, 18 percent of
patients in the exenatide group achieved this level compared to 9
percent in the biphasic insulin aspart group. These findings were
presented at the 42nd annual meeting of the European Association of
the Study of Diabetes (EASD) in Copenhagen, Denmark.
Patients on exenatide lost an average of 2.5 kilograms (5.5
pounds), while those receiving biphasic insulin aspart gained an
average of 2.9 kilograms (6.4 pounds). Weight gain is a common side
effect of insulin therapy. In addition, exenatide reduced peak blood
sugar levels after meals. Both treatments were associated with low
rates of daytime and nighttime hypoglycemia (low blood sugar).
"This comparator study demonstrates that exenatide has similar
blood glucose control to the conventional treatment with insulin,"
said Professor Dr. Michael Nauck, Director of the Diabetes Centre in
Bad Lauterberg, Germany, and a lead author of the study. "These data
show that exenatide, without the inconvenience of dose titration, is
a potential alternative to biphasic insulin aspart for the treatment
of patients with type 2 diabetes not adequately treated with
metformin and a sulfonylurea, commonly used oral antidiabetic
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.
- Both treatment groups achieved similar HbA1C reductions.
Exenatide lowered HbA1C by 1.04 percent while biphasic insulin aspart
lowered HbA1C by 0.89 percent.
- When measured against the target HbA1C of less than or equal to
7 percent, 32 percent of patients in the exenatide group achieved
this level compared to 24 percent in the biphasic insulin aspart
- When measured against the target HbA1C of less than or equal to
6.5 percent, 18 percent of patients in the exenatide group achieved
this level compared to 9 percent in the biphasic insulin aspart
- As measured by patient self-glucose monitoring, exenatide
reduced postprandial excursions, the rise of glucose after meals,
following breakfast and dinner. Biphasic insulin aspart reduced
mainly pre-meal glucose.
- The fasting blood glucose at endpoint was decreased in patients
treated with exenatide by 1.8 mmol/L and by 1.6 mmol/L in patients
treated with biphasic insulin aspart.
- Weight loss in the exenatide arm: Patients treated with
exenatide experienced an average weight reduction of 2.5 kilograms
- Weight gain in the biphasic insulin aspart: On average, patients
treated with insulin gained 2.9 kilograms (6.4 pounds).
- After 52 weeks, the total weight difference between treatments
was -5.4 kilograms (11.9 pounds).
- Both exenatide and biphasic insulin aspart had low rates of
daytime and nighttime hypoglycemia.
- No severe hypoglycemia was reported in either the exenatide or
the biphasic insulin aspart arm.
Other adverse events:
- The most common adverse event for exenatide was nausea (33.2
percent exenatide, 0.4 percent biphasic insulin aspart), which was
generally mild-to-moderate and tended to decrease in frequency and
severity over time. Four percent of exenatide-treated patients
discontinued due to nausea.
501 patients were enrolled in the 52-week, multi-center,
open-label, randomized trial. The trial was designed to determine if
exenatide can be used as safely and effectively as biphasic insulin
aspart in patients with type 2 diabetes inadequately treated with
metformin plus a sulfonylurea.
Study participants were randomized into two treatment arms. The
first group received a dose of exenatide (5 micrograms twice-a-day
for first four weeks, then 10 micrograms twice-a-day for the
remainder of the study), in conjunction with metformin and a
sulfonylurea. The second group received biphasic insulin aspart
(titrated to achieve an optimal balance between glycemic control and
risk of hypoglycemia as dictated by best clinical practice), again
with metformin and a sulfonylurea. The average HbA1C at baseline was
8.6 percent in both treatment groups.
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.(2)
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.
Diabetes affects an estimated 194 million adults worldwide(3) and
around 48.4 million in Europe.(4) 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.(5) Type 2 diabetes usually occurs
in adults over the age of 40, but is increasingly common in younger
people.(4) 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)(6). The calculated estimates of the costs of diabetes care
in Europe amount to 42.8 million International Dollars per year.(7)
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
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
(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) 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.
(3) 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.
(4) The International Diabetes Federation, Prevalence / All
diabetes. Available at
(5) 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.
(6) The International Diabetes Federation, Complications.
Available at http://www.eatlas.idf.org/Complications/
(7) The International Diabetes Federation, Diabetes Atlas, Second
edition. The Economic Impact of Diabetes. 2003: 186.
ots Originaltext: Eli Lilly and Company
Im Internet recherchierbar: http://www.presseportal.ch
Lilly - Derin Denham, +1-317-277-6749 (office), +1-317-370-1435
(mobile); Amylin - Alice Bahner, +1-858-642-7272 (office),
+1-858-232-9072 (mobile). Photo: NewsCom:
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