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
(on-site New Orleans)
(LLY)
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