Lilly Announces Positive Phase Ii Data On Investigational Medicine For Patients With Type 2 Diabetes

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7th June 2009, 03:06am - Views: 826





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Lilly Announces Positive Phase II Data on Investigational Medicine for Patients with Type 2 Diabetes


NEW ORLEANS, June 7 /PRNewswire-AsiaNet/ --


    Eli Lilly and Company (NYSE: LLY) announced today new, positive Phase II

study results of LY2189265, its investigational glucagon-like peptide 1

(GLP-1) analog administered subcutaneously once-weekly for the treatment of

type 2 diabetes. These data will be presented as part of the American

Diabetes Association's (ADA) 69th Annual Scientific Sessions.


    In the Phase II study, known as GBCJ, LY2189265 was significantly

superior to placebo in reducing key measures of glycemic control, including

fasting serum glucose and hemoglobin A1C (HbA1C). In this study, LY2189265

showed an insulinotropic (stimulating the secretion of insulin) effect,

suggesting it produced the desired outcome in participants. In Study GBCJ,

LY2189265 was generally well-tolerated.


    "We are excited about these data and the hope they could provide to the

millions of diabetes patients who are struggling to maintain tight control of

their blood glucose," said Pawel Fludzinski, Ph.D., global development leader

for the GLP-1Fc team. "Evaluating the results of this study is an important

step forward towards potentially bringing this innovative treatment to

patients."


    About Study GBCJ

    In a 16-week, Phase II study of LY2189265, 262 patients with type 2

diabetes who were suboptimally controlled on at least two oral diabetes

medicines were randomized to one of four arms: 1.0 mg of LY2189265 for 16

weeks; 0.5 mg of LY2189265 for four weeks followed by 1.0 mg for 12 weeks;

and 1.0 mg of LY2189265 for four weeks followed by 2.0 mg for 12 weeks or

placebo. The primary endpoint was glycemic control, as measured by change

from baseline in HbA1C; additional endpoints evaluated included changes in

fasting serum glucose, solid mixed meal glucose excursion and body weight.


    For all doses in this study, statistically significant reductions in all

metabolic measures were observed. Both 1 mg and 2 mg doses of LY2189265 were

significantly different from placebo, but no significant differences between

the doses were seen. LY2189265 was generally well-tolerated. The incidence of

hypoglycemic episodes was not significantly different between the placebo and

the treatment groups. The most frequently observed treatment-related adverse

events were nausea, diarrhea and abdominal distension. One patient was

diagnosed with clinical pancreatitis, following the eleventh dose of

LY2189265. The patient remained in the study for observation and has fully

recovered.


    "Given our more than 80 years of experience in pioneering diabetes

treatments, we are encouraged by these data," noted Steve Paul, M.D.,

executive vice president, science and technology, and president of Lilly

Research Laboratories. "In this study, LY2189265 was administered once weekly

and demonstrated significant glucose-lowering activity and reduced body

weight, supporting its potential to become a new treatment option for the

millions of people with type 2 diabetes."


    About LY2189265

    LY2189265, a once-weekly injection, is a novel-engineered fusion protein,

consisting of a dipeptidyl peptidase-IV (DDP-IV) protected GLP-1 analog

linked to a fragment of immunoglobulin G4 that is believed to increase the

duration of its pharmacological effect. Based on this study presented at this

year's ADA meeting, LY2189265 is believed to reduce blood sugar in patients

with type 2 diabetes by enhancing glucose-dependent insulin secretion from

the pancreas.


    Diabetes: A Global Epidemic

    Researchers say new diabetes treatments are needed because the disease is

growing globally at epidemic proportions. Currently, about 24 million

Americans have diabetes(1), with 90-95 percent of those suffering from type 2

diabetes(2). It is estimated that nearly 60 percent of the people with

diabetes are not achieving treatment goals for controlling blood sugar(3),

putting them at serious risk for debilitating or potentially fatal

complications including heart disease, stroke, nerve damage, lower limb

amputation, vision loss and kidney disease(4).


    About Lilly

    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, Ind., Lilly provides answers - through medicines and

information - for some of the world's most urgent medical needs.


    This press release contains forward-looking statements about the

potential of the investigational compound LY2189265 for the treatment of type

2 diabetes and reflects Lilly's current beliefs. However, as with any

pharmaceutical product under development, there are substantial risks and

uncertainties in the process of development and regulatory review. There is

no guarantee that the product will receive regulatory approval, or that the

regulatory approval will be for the indication(s) anticipated by the company.

There is also no guarantee that the product will prove to be commercially

successful. For further discussion of these and other risks and

uncertainties, see Lilly's filings with the United States Securities and

Exchange Commission. Lilly undertakes no duty to update forward-looking

statements.


    C-LLY


    (1) American Diabetes Association. "Diabetes Statistics." Available at:



    (2) Centers for Disease Control and Prevention. "National Diabetes Fact


Accessed May 13, 2009


    (3) Saydah SH, Fradkin J and Cowie CC. "Poor control of risk factors for

vascular disease among adults with previously diagnosed diabetes." JAMA:

291(3), January 21, 2004


    (4) Centers for Disease Control and Prevention. "National Diabetes Fact


Accessed May 13, 2009




     SOURCE:  Eli Lilly and Company


    CONTACT: Christine Van Marter

             Eli Lilly and Company

             +1-317-554-7923

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             (on-site New Orleans)

             (LLY)


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