Type 2 Diabetes Patients With Long-standing Disease Achieved Glycaemic Control

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27th June 2010, 03:40am - Views: 844

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Type 2 Diabetes Patients with Long-Standing Disease Achieved Glycaemic Control When

BYETTA(R) (exenatide) Injection Was Added to Insulin Glargine

ORLANDO, Fla., June 26 /PRNewswire-AsiaNet/ --

                           Study Presented at ADA 2010

    Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company

(NYSE: LLY) today announced results from the first double-blind,

placebo-controlled clinical study to evaluate exenatide injection added to

insulin glargine, which showed patients with type 2 diabetes achieved glucose

targets without weight gain or increasing their risk of hypoglycaemia. These

findings were presented at the 70th Annual Scientific Sessions of the

American Diabetes Association (ADA) in Orlando, Fla.

    In the study, patients receiving insulin glargine, with or without oral

agents, were randomized to receive exenatide or placebo in addition to

aggressive insulin titration. After 30 weeks of treatment, HbA1c decreased by

1.7 percentage points in patients adding exenatide, compared with a decrease

of 1.0 percentage point in patients treated with insulin alone. Weight

decreased in patients adding exenatide by 1.81 kilograms, compared with an

increase of 0.90 kilograms in patients treated with insulin alone. Fasting

plasma glucose and hypoglycaemia were similar between treatment groups.

    "Even in this population of patients who were poorly controlled on

insulin therapy, the addition of exenatide to optimized basal insulin therapy

provided exactly what we hoped for - improved control of blood sugar

throughout the day, weight loss and no increased risk of hypoglycaemia as

compared to optimized basal insulin treatment alone," said John Buse, M.D.,

Ph.D., Professor of Medicine, Director of the Diabetes Care Center, and Chief

of the Division of Endocrinology at the University of North Carolina School

of Medicine in Chapel Hill. "This study showed exenatide may provide a

complementary addition to basal insulin for these hard-to-treat type 2

diabetes patients."

    Exenatide is not currently approved for this dosing regimen. Results from

this study will form the basis for a supplemental New Drug Application (sNDA)

to the U.S. Food and Drug Administration (FDA). The filing is planned for the

end of 2010.

    Study Design and Findings

    The double-blind, placebo-controlled study enrolled 261 patients (mean

age: 59 years old; weight: 93.89 kilograms; HbA1c: 8.4 percent; diabetes

duration: 12 years; insulin dose 48 units) who were randomized to exenatide

10 micrograms (n=137) or placebo (n=122). Groups were generally comparable at

baseline. Insulin dose was decreased by 20 percent if a patient's HbA1c was <

/ = 8 percent or maintained if a patient's HbA1c was >8 percent for five

weeks, then titrated to achieve a target fasting glucose of <5.55 mmol/l.

Primary endpoint was change in HbA1c, a measure of average blood sugar over

three months. Continuous glucose monitoring (n=23) and 7-point glucose

profiles demonstrated significant postprandial effects with exenatide

compared with insulin alone. Insulin dose increased more in the placebo group

(20 +/- 2 units) than in the exenatide group (13 +/- 2 units) to achieve the

fasting glucose target.

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    Safety Profile

    Overall, nausea was the most common event during the 30-week treatment

period and decreased over time. Nausea occurred in 41 percent of patients

treated with exenatide compared with 8 percent of patients treated with

insulin alone. Hypoglycaemia was similar for both groups; major hypoglycaemia

occurred twice in one patient receiving insulin alone.

    About Diabetes

    It is estimated that by 2010, diabetes will affect 284.6 million adults

worldwide and more than 55.4 million in Europe.(i, ii) 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


    Type 2 diabetes usually occurs in adults over the age of 40, but is

increasingly common in younger people.(iv) In virtually every high-income

country, diabetes is ranked among the leading causes of blindness, renal

failure and lower limb amputation as well as one of the leading causes of

death, largely because of a markedly increased risk of coronary heart disease

and stroke (cardiovascular disease).(v) In the European region, estimates

indicate that at least 106 billion USD will be spent on healthcare for

diabetes in 2010, accounting for 28 percent of global expenditure.(vi)

    About exenatide Injection

    Exenatide was the first approved incretin mimetic, a 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.(vii)

Exenatide is approved in the European Union as adjunctive therapy to improve

blood sugar control in patients with type 2 diabetes who have not achieved

adequate glycaemic control on maximally tolerated doses of metformin and/or a

sulfonylurea, two common oral diabetes medications. Since the U.S. market

introduction in June 2005, more than one million patients worldwide have been

treated with exenatide.

    Important Safety Information for exenatide

    In clinical studies, the most common side effects were hypoglycaemia (low

blood sugar) when taken with a sulfonylurea, nausea (feeling sick), vomiting

and diarrhea. For the full list of all side effects reported with exenatide,

see the Package Leaflet. Exenatide should not be used in people who may be

hypersensitive (allergic) to exenatide or any of the other ingredients.

    About Amylin and Lilly

    Amylin Pharmaceuticals is a biopharmaceutical company dedicated to

improving lives of patients through the discovery, development and

commercialization of innovative medicines. Amylin has developed and gained

approval for two first-in-class medicines for diabetes, SYMLIN(R)

(pramlintide acetate) injection and BYETTA(R) (exenatide) injection. Amylin's

research and development activities leverage the Company's expertise in

metabolism to develop potential therapies to treat diabetes and obesity.

Amylin is headquartered in San Diego, California. Further information on

    Through a long-standing commitment to diabetes care, Lilly seeks to

provide patients with breakthrough treatments that enable them to live

longer, healthier and fuller lives. Since 1923, Lilly has been an industry

leader in pioneering therapies to help healthcare professionals improve the

lives of people with diabetes, and research continues on innovative medicines

to address the unmet needs of patients. For more information about Lilly's

current diabetes products, visit www.lillydiabetes.com.

    Lilly, a leading innovation-driven corporation, is developing a growing

portfolio of pharmaceutical products by applying the latest research from its

Business Company Eli Lilly And Company 4 image

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

    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 exenatide, and/or the revenues generated from exenatide, may be

affected by competition; unexpected new data; safety and technical issues;

the study results mentioned in this press release not being predictive of

real-world results; clinical trials not being completed in a timely manner,

not confirming previous results, not being predictive of real-world use, or

not achieving the intended clinical endpoints; label expansion requests not

receiving regulatory approval; or manufacturing and supply issues. The

potential for exenatide may also be affected by government and commercial

reimbursement and pricing decisions; the pace of market acceptance; or

scientific, regulatory and other issues and risks inherent in the development

and commercialization of pharmaceutical products, including those inherent in

the collaboration with and dependence upon Amylin and/or Lilly. These and

additional risks and uncertainties are described more fully in Amylin's and

Lilly's most recent SEC filings, including their Quarterly Reports on Form

10-Q and Annual Reports on Form 10-K. Amylin and Lilly undertake no duty to

update these forward-looking statements.

    BYETTA(R) is a registered trademark of Amylin Pharmaceuticals, Inc. All

other marks are the marks of their respective owners.

    (i) The International Diabetes Federation Diabetes Atlas. Available at:


    (ii) The International Diabetes Federation Diabetes Atlas. Available at:

    (iii) 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.

    (iv) The International Diabetes Federation Diabetes Atlas. Available at


    (v) The International Diabetes Federation Diabetes Atlas. Available at


    (vi) The International Diabetes Federation Diabetes Atlas. Available at:

    (vii) 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;


     SOURCE:  Eli Lilly and Company

    CONTACT:  Amylin - Anne Erickson


              Cell: +1-858-349-3195

              anne.erickson@amylin.com; or

              Lilly - Tim Coulom


              Cell: +1-317-544-9757

              Email: coulomtd@lilly.com

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