Lilly Announces Positive Phase II Data on Investigational Medicine for Patients with Type 2 Diabetes
June 06 2009 - 11:00AM
PR Newswire (US)
NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- 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:
http://www.diabetes.org/diabetes-statistics.jsp Accessed May 13,
2009. (2) Centers for Disease Control and Prevention. "National
Diabetes Fact Sheet 2007." Available at
http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2007.pdf 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 Sheet 2007."
Available at http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2007.pdf
Accessed May 13, 2009 (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO ) DATASOURCE:
Eli Lilly and Company CONTACT: Christine Van Marter, Eli Lilly and
Company, +1-317-554-7923 (on-site New Orleans)
Copyright