TIDMLEL 
 
Date: May 22, 2012 
 
For Release: Embargoed until May 22, 2012, 8:00 AM EDT 
 
Refer to: +1 317.701.4007 - Kelley Murphy 
 
    Lilly Diabetes Presents Phase II Blood Pressure and Heart Rate Data on 
 Investigational GLP-1 Analog Candidate, Dulaglutide, in Patients with Type 2 
                                Diabetes at the 
           27th American Society of Hypertension Scientific Meeting 
 
           Phase II Trial Used Ambulatory Blood Pressure Monitoring 
 
           to Evaluate Blood Pressure and Heart Rate for Dulaglutide 
 
New York, May 22, 2012 - Eli Lilly and Company (NYSE: LLY) today announced that 
dulaglutide, its investigational, long-acting glucagon-like peptide 1 (GLP-1) 
analog being studied as a once-weekly treatment for type 2 diabetes, met its 
primary endpoint of non-inferiority for mean 24-hour systolic blood pressure 
(SBP, or pressure while the heart contracts) after 16 weeks. The results came 
from a Phase II study that compared two doses of dulaglutide to placebo, using 
ambulatory blood pressure monitoring (ABPM) to characterize changes in blood 
pressure and heart rate. In addition, the 1.5 mg dulaglutide dose significantly 
reduced mean 24-hour SBP compared to placebo. These data were presented during 
a late-breaking clinical trial session at the 2012 Annual Scientific Meeting of 
the American Society of Hypertension (ASH) in New York. 
 
"Cardiologists and hypertension specialists are increasingly involved with 
evaluating the cardiovascular effects of diabetes medications," said Keith C. 
Ferdinand, M.D., FACC, FAHA, FASH, professor of clinical medicine, Section of 
Cardiology, Tulane University School of Medicine. "This study used the gold 
standard measurement technique of ABPM to evaluate the blood pressure and heart 
rate effects of dulaglutide, an investigational GLP-1 receptor agonist." 
 
ABPM is a non-invasive, fully automated technique to measure blood pressure at 
specific intervals (usually every 15-30 minutes) throughout an entire 24-hour 
period. This approach allows clinicians to more accurately characterize a 
person's blood pressure levels throughout a normal day. 
 
"We are very encouraged by these clinical trial results, in addition to the 
rest of the clinical trial data we've seen to date for dulaglutide," said Gwen 
Krivi, Ph.D., vice president, product development, Lilly Diabetes. "Dulaglutide 
is currently in Phase III clinical trials, where it will continue to be 
evaluated on its efficacy to lower blood glucose levels, overall safety, weight 
effects and effects on cardiovascular outcomes. We believe dulaglutide, if 
approved, can bring significant benefits to people with type 2 diabetes." 
 
Both dulaglutide doses were shown to be non-inferior (NI) (margin 3 mmHg) 
compared to placebo at week 16 for mean 24-hour SBP, which was the primary 
objective of the study. Since the NI criterion was satisfied, superiority 
testing was conducted, and the 1.5 mg dose demonstrated statistically 
significant reductions in mean 24-hour SBP compared to placebo. 
 
  * Dulaglutide 0.75 mg: -1.07 mmHg (97.3% CI: -2.83, 0.68) 
 
  * Dulaglutide 1.5 mg: -2.79 mmHg (97.3% CI: -4.58, -1.00) 
 
Similar results were observed for comparisons at week 26. 
 
The study also had several secondary objectives, including effects on mean 
24-hour diastolic blood pressure (DBP, or pressure when the heart relaxes 
between beats) and mean 24-hour heart rate. For mean 24-hour DBP, the NI 
criterion (2.5 mmHg) was met for both dulaglutide doses compared to placebo at 
weeks 16 and 26. 
 
For mean 24-hour heart rate, the 0.75 mg dulaglutide dose met the NI criterion 
(3 bpm) at both weeks 16 and 26 compared to placebo (1.62 bpm [97.3% CI: 0.32, 
2.92] and 1.26 bpm [97.3% CI: -0.13, 2.64], respectively). The 1.5 mg dose did 
not meet the NI criterion at either week 16 (2.84 bpm [97.3% CI: 1.52, 4.16] or 
week 26 (3.50 bpm [97.3% CI: 2.10, 4.91]). This effect on heart rate is 
consistent with what has been observed for other compounds in the GLP-1 agonist 
class. 
 
Both doses of dulaglutide demonstrated statistically significant reductions in 
HbA1c (average blood glucose levels over a three-month period) from baseline, 
compared to placebo, at weeks 16 and 26. 
 
The most frequently reported adverse events were gastrointestinal (including 
diarrhea, nausea and vomiting). This is consistent with other GLP-1 agonists. 
 
About the Study 
 
This Phase II, randomized, double-blind, placebo-controlled, 26-week, parallel 
study included 755 patients with type 2 diabetes on one or more oral diabetes 
medications, of whom about 67 percent had a preexisting diagnosis of 
hypertension. Patients who were hypertensive took three or fewer 
antihypertensive medications, with a stable regimen for at least 30 days and no 
change on study. The study evaluated whether changes from baseline to week 16 
in mean 24-hour SBP of dulaglutide 0.75 mg and dulaglutide 1.5 mg, dosed 
once-weekly, were NI to placebo, as measured by ABPM, using a NI margin of 3 
mmHg. Superiority testing was performed if the statistical criterion for 
non-inferiority was satisfied. 
 
About Diabetes 
 
Approximately 25.8 million Americans and an estimated 366 million people 
worldwide have type 1 and type 2 diabetes. Type 2 diabetes is the most common 
type, accounting for an estimated 90 to 95 percent of all diabetes cases. 
Diabetes is a chronic disease that occurs when the body either does not 
properly produce, or use, the hormone insulin. 
 
About Lilly Diabetes 
 
Lilly has been a global leader in diabetes care since 1923, when we introduced 
the world's first commercial insulin. Today we work to meet the diverse needs 
of people with diabetes through research and collaboration, a broad and growing 
product portfolio and a continued commitment to providing real solutions - from 
medicines to support programs and more - to make lives better. For more 
information, visit www.lillydiabetes.com. 
 
About Eli Lilly and Company (NYSE: LLY) 
 
Lilly, a leading innovation-driven corporation, is developing a growing 
portfolio of 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. Additional information about Lilly is available at www.lilly.com. P-LLY 
 
                                     # # # 
 
This press release contains forward-looking statements about dulaglutide that 
are based on Lilly's current expectations. There are significant risks and 
uncertainties in the process of drug development and commercialization. There 
can be no guarantee that future study results and patient experience will be 
consistent with the study findings to date, that dulaglutide will receive the 
necessary clinical and manufacturing regulatory approvals, or that it will 
prove to be commercially successful. For further discussion of these and other 
risks and uncertainties, please see the company's latest Forms 10-K and 10-Q 
filed with the U.S. Securities and Exchange Commission. The company undertakes 
no duty to update forward-looking statements. 
 
 
 
 
 
 
 
 
 
Eli Lilly and Company 
 
Lilly Corporate Center 
 
Indianapolis, Indiana 46285 
 
U.S.A. 
 
Centers for Disease Control. National Diabetes Fact Sheet-2011. Available at: 
http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed on: February 22, 
2012. 
 
International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet. 
2011. 
 
International Diabetes Federation. Diabetes Atlas, 5th Edition: What is 
Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: 
February 22, 2012. 
 
 
 
 
END
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