INDIANAPOLIS, Dec. 1, 2015
/CNW/ -- New data from a completed Phase 3 trial show
Trulicity® (dulaglutide) solution for injection 1.5 mg
plus a sulfonylurea was significantly more effective than a
sulfonylurea alone in lowering HbA1c from baseline after 24 weeks
of treatment.1 Trulicity is Eli Lilly and Company's
once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist for
the treatment of type 2 diabetes. These data, from the Trulicity
AWARD-8 clinical trial, were presented for the first time today at
the 2015 International Diabetes Federation (IDF) World Diabetes
Congress in Vancouver, Canada.
"For patients who cannot tolerate or have contraindications to
metformin, a sulfonylurea is often prescribed as first-line therapy
for type 2 diabetes," said Kathleen
Dungan, M.D., endocrinologist, associate professor, The
Ohio State University Wexner Medical
Center, and lead study author. "This study affirms that Trulicity
is efficacious and well-tolerated as an add-on to sulfonylurea
therapy, which can help prescribers make treatment decisions for
their individual patients."
At the primary endpoint of 24 weeks, Trulicity 1.5 mg plus
sulfonylurea provided superior HbA1c reduction from baseline (-1.38
percent) compared to sulfonylurea with placebo (-0.11 percent).
Additionally:
- Significantly more patients treated with Trulicity 1.5 mg plus
sulfonylurea achieved an HbA1c of less than 7 percent (55.3
percent) compared to sulfonylurea with placebo (18.9 percent);
and
- Trulicity plus a sulfonylurea significantly reduced fasting
serum glucose levels (the amount of sugar in the blood in a fasting
state) compared to sulfonylurea with placebo (-1.70 mmol/L vs.
+0.16 mmol/L).
As a secondary endpoint of the study, Trulicity plus a
sulfonylurea showed weight reduction from baseline (-0.91 kg),
though the difference compared to sulfonylurea with placebo did not
reach statistical significance.1
The most commonly reported adverse events were
gastrointestinal-related and consistent with prior Trulicity
studies, including nausea (10.5 percent) and diarrhoea (8.4
percent). There were no cases of pancreatitis or pancreatic cancer
in either treatment group. As expected, more patients treated with
Trulicity plus a sulfonylurea experienced episodes of hypoglycaemia
compared to those treated with sulfonylurea alone, though the
overall incidence of documented symptomatic hypoglycaemia was low
in the Trulicity group (11.3 percent) and there were no reported
cases of severe hypoglycaemia in either group. 1
"The AWARD-8 study demonstrated Trulicity's safety and efficacy
as add-on therapy to sulfonylurea," said Jessie Fahrbach, M.D., medical director, Lilly
Diabetes. "These data add to the comprehensive body of evidence for
Trulicity, reinforcing its value as a type 2 diabetes treatment
option."
About the AWARD-8 Study1
This Phase 3,
randomised, double-blind, placebo-controlled, 24-week study
compared the efficacy and safety of once-weekly Trulicity 1.5 mg to
placebo in sulfonylurea-treated patients with type 2 diabetes and
inadequate glycaemic control. The primary objective of the study,
in 299 patients with a mean baseline HbA1c of 8.4 percent, was to
demonstrate superiority of Trulicity 1.5 mg to placebo on HbA1c
reduction in patients treated with sulfonylurea monotherapy.
About
Trulicity® (dulaglutide)
Solution for Injection
Trulicity is a once-weekly, GLP-1
receptor agonist injectable prescription medicine. Trulicity is not
insulin. It acts like GLP-1, a natural hormone, helping the body
release its own insulin when patients eat to control blood
sugar.
Trulicity comes in a pen that does not require the patient to
mix, measure or handle the needle. It can be taken any time of day,
with or without meals, and should be injected subcutaneously in the
abdomen, thigh or upper arm.
About Diabetes
An estimated 415 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 does not either properly produce or use
the hormone insulin.2
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
Lilly is a
global healthcare leader that unites caring with discovery to make
life better for people around the world. We were founded more than
a century ago by a man committed to creating high-quality medicines
that meet real needs, and today we remain true to that mission in
all our work. Across the globe, Lilly employees work to discover
and bring life-changing medicines to those who need them, improve
the understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at www.lilly.com and
newsroom.lilly.com/social-channels.
Trulicity® is a registered trademark owned or
licensed by Eli Lilly and Company, its subsidiaries, or
affiliates.
This press release contains forward-looking statements about
Trulicity for the treatment of type 2 diabetes along with diet and
exercise. It reflects Lilly's current beliefs; however, as with any
such undertaking, there are substantial risks and uncertainties in
the process of drug development and commercialisation. There is no
guarantee that future study results and patient experience will be
consistent with study findings to date or that Trulicity will prove
to be commercially successful. For further discussion of these and
other risks and uncertainties, please see Lilly's latest Forms 10-Q
and 10-K filed with the U.S. Securities and Exchange Commission.
Lilly undertakes no duty to update forward-looking
statements.
References
- Dungan K, Weitgasser R, Manghi FP, et. al. Efficacy and
Safety of Once Weekly Dulaglutide Added on to Sulfonylurea in Type
2 Diabetes (AWARD-8). Abstract 0219-PD. Presented at 2015
International Diabetes Federation (IDF) World Congress; 30 November
– 4 December, Vancouver,
Canada.
- International Diabetes Federation. IDF Diabetes Atlas,
7th edn. Brussels, Belgium:
International Diabetes Federation, 2015.
http://www.idf.org/diabetesatlas.
Refer to: Candace Johnson,
johnson_candace_a@lilly.com, (317) 755-9143
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SOURCE Eli Lilly and Company