Baseline Data From European Observational Study Highlights Characteristics of Patients with Type 2 Diabetes Initiating Insulin


AMSTERDAM, Netherlands, September 20 /PRNewswire/ --

- More than 12 months prior to initiation of insulin, patients had a mean
HbA1c of 8.3, while at initiation patients had a mean HbA1c of 9.6

Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN) and Eli Lilly and Company
(NYSE: LLY) today announced baseline data from INSTIGATE, a 24-month study
presented at the 43rd Annual Meeting of the European Association for the
Study of Diabetes (EASD) in Amsterdam, The Netherlands. Study findings
indicate that people with type 2 diabetes in Europe had insulin initiated at
a mean HbA1c of 9.6 percent and more than 12 months prior to initiation the
mean HbA1c was 8.3 percent. The International Diabetes Federation recommends
a target HbA1c of 6.5 percent or less.(1) The INSTIGATE study is an ongoing
prospective observational study to gather data on medications for diabetes,
clinical outcomes, health related quality of life and cost and resource use
when patients with type 2 diabetes initiate insulin, in the six months prior
to insulin initiation and over the following two years.

"The issue of when to start, add or switch diabetes therapies is often a
difficult decision for physicians and diabetes specialists, and can have
considerable influence on patient care and the costs of disease management,"
said Dr. Andreas Liebl, Medical Director of the Center for Diabetes and
Metabolism in Bad Heilbrunn, Germany.

There were several differences across countries among the enrolled
participants. Despite these differences, there were common characteristics of
the patients in Europe:

- When starting on insulin, patients had mean HbA1c levels above commonly
      accepted treatment targets in all countries.
    - More than 12 months prior to insulin initiation, the mean HbA1c across
      all countries was 8.3% (SD= 1.3%; n=567).
    - At the start of insulin treatment, patients had a mean HbA1c of 9.6%
      and a mean body mass index (BMI) of 29.9 kilograms/meters squared
      (BMI over 25 is considered 'overweight' and BMI over 30 is considered
      'obese').

"The INSTIGATE data underscore the importance of successful disease
management," said Dr. Liebl. "At the point of initiating insulin these
patients have high body mass indexes (BMI), long duration of diabetes and
mean HbA1c at insulin initiation above commonly accepted treatment targets in
all countries."

Good glycaemic control can significantly benefit a patient with type 2
diabetes. In fact, according to the United Kingdom Prospective Diabetes Study
(UKPDS), a reduction of 1 percent in the mean HbA1c concentration is
associated with a 21 percent reduction in the risk of death related to
diabetes, a 14 percent reduction in the risk for myocardial infarction and a
37 percent reduction in the risk of microvascular complications.(2)

Between November 2005 and October 2006, 1172 patients with type 2
diabetes across 5 countries -- UK, Germany, France, Spain, Greece -- were
enrolled in the INSTIGATE study.

About Diabetes

Diabetes affects an estimated 246 million adults worldwide and more than
48 million in Europe.(3,4) Approximately 90 to 95 percent of those are
affected by type 2 diabetes, a condition characterized by failure of the
pancreatic beta-cell 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.(6) 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
billion International Dollars per year.(8)

About INSTIGATE

1172 patients with type 2 diabetes across 5 countries (UK, Germany,
France, Spain, Greece) who have initiated insulin as part of usual care were
enrolled in this study. The objective was to assess the resource utilization,
direct costs, quality of metabolic control and clinical outcomes associated
with the first 6 months of insulin therapy in patients with type 2 diabetes
and the 6 months prior to insulin initiation retrospectively. The study was
also designed to observe clinical and patient reported outcomes relating to
treatment regimens and resources use over the first 24 months of insulin
therapy.

About Amylin and Lilly

Amylin Pharmaceuticals is a biopharmaceutical company committed to
improving lives through the discovery, development and commercialization of
innovative medicines. Amylin has developed and gained approval for two
first-in-class medicines for diabetes. Amylin's research and development
activities leverage the company's expertise in metabolism to develop
potential therapies to treat diabetes and obesity. Amylin is located in San
Diego, California with over 1,700 employees nationwide.

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, Indiana, Lilly provides answers -- through medicines and
information -- for some of the world's most urgent medical needs.

REFERENCES

(1)
http://www.idf.org/webdata/docs/GGT2D%2006%20Glucose%20control%20levels.pdf

(2)Stratton IM, Adler AI, Neil HAW, Matthews DR, et al. Association of
glycaemic control with macrovascular and microvascular complications
of type 2 diabetes (UKPDS): prospective observational study. BMJ.
2000;321;405-412.

(3)The International Diabetes Federation Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC2268
2A. Accessed June 14, 2007.

(4)The International Diabetes Federation, Prevalence / All diabetes.
Available at http://www.eatlas.idf.org/Prevalence/All_diabetes/.

(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, Prevalence / All diabetes.
Available at http://www.eatlas.idf.org/Prevalence/All_diabetes/.

(7)The International Diabetes Federation, Complications. Available
at http://www.eatlas.idf.org/Complications/

(8)The International Diabetes Federation, Diabetes Atlas, Second
edition. The Economic Impact of Diabetes. 2003: 186.

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