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Sanofi-aventis: Investigational Compound Once-Daily Lixisenatide Demonstrated Significant Improvement in Glucose Control in Patients With Type 2 Diabetes

Paris (ots/PRNewswire)

Sanofi-aventis  announced
today the first Phase III results of the GetGoal clinical trial
program assessing the efficacy and safety of lixisenatide, a
once-daily GLP-1 receptor agonist, as monotherapy in patients with
type 2 diabetes. These results were presented at the European
Association for the Study of Diabetes (EASD) 46th Annual Meeting in
Stockholm, Sweden.
"These results demonstrated lixisenatide as a once daily GLP-1
agent with substantial A1C reduction and a pronounced effect on
post-meal glucose control," said Dr. John E. Gerich of the University
of Rochester School of Medicine and an investigator of the presented
study. "The pronounced effect on postprandial glucose control
provides a rationale to investigate the combined effect of
lixisenatide and long-acting insulins in patients with type 2
diabetes."
The safety and efficacy of lixisenatide as monotherapy in
patients with type 2 diabetes was assessed in a 12-week, randomized,
double-blind, multicenter Phase III study. The study found that
lixisenatide monotherapy administered once daily significantly
improved glycemic control with a pronounced postprandial effect. The
study also demonstrated that the therapy had an acceptable safety
profile in patients with type 2 diabetes.
A total of 361 patients with type 2 diabetes (baseline A1C
levels: 7 to 10 percent, mean age 53.7 years, mean diabetes duration
2.5 years) not currently receiving glucose-lowering therapy were
randomized to: lixisenatide two-step titration (10 microg for 1 week,
15 microg for 1 week then 20 microg; n=120); lixisenatide one-step
titration (10 microg for 2 weeks then 20 microg; n=119) or placebo
(n=122).
Lixisenatide significantly reduced A1C levels in both titration
groups versus placebo (p<0.0001). There was a significantly higher
number of patients achieving A1C levels less than or equal to 6.5
percent  with lixisenatide (31.9% two-step, 25.4% one-step) and <7.0
percent  (52.2% two-step, 46.5% one-step) versus placebo (p<0.01).
Lixisenatide significantly reduced the mean change from baseline
two-hours postprandial glucose by respectively -4.51 and -5.47 mmol/L
(p<0.0001) in the one-step and two-step titration groups with mean
decreases in body weight observed in all groups. In addition,
lixisenatide once-daily reduced glucose excursion respectively by
-3.77 and -4.36 mmol/L in the one-step and two-step titration groups
with mean decreases in body weight observed in all groups.
Lixisenatide was well tolerated. Only one serious
treatment-emergent adverse event (TEAE) occurred in the lixisenatide
group (0.4%) versus five in the placebo group (4.1%). Nausea was the
most frequent TEAE with lixisenatide (24.2% for lixisenatide 2-step,
20.2% for lixisenatide 1-step, 4.1% for placebo). The rate of
symptomatic hypoglycemia was 1.7 percent and 1.6 percent in the
lixisenatide and placebo groups, respectively.
About Lixisenatide (AVE 0010)
Lixisenatide, a glucagon-like peptide-1 agonist (GLP-1), is in
development for the treatment of patients with type 2 diabetes
mellitus. Lixisenatide was in-licensed by sanofi-aventis from Zealand
Pharma A/S (Copenhagen, Denmark).
The efficacy and safety of lixisenatide once-daily is being
assessed in the GetGoal Phase III clinical trial program. The GetGoal
clinical trial program started in May 2008 and has enrolled more than
4,500 patients. The enrollment of the eight other studies of the
GetGoal Phase III program assessing efficacy and safety of
lixisenatide in adult patients with type 2 diabetes mellitus treated
with various oral antidiabetic agents or insulin was completed at the
end of 2009.
The next results of the GetGoal Phase III program are expected to
be released in Q2 2011.
About GLP-1 Receptor Agonists
GLP-1 is a naturally occurring peptide that is released within
minutes of eating a meal. It is known to suppress glucagon secretion
from pancreatic alpha cells and stimulate insulin secretion by
pancreatic beta cells. GLP-1 receptor agonists are in development as
an add-on treatment for type 2 diabetes and their use is endorsed by
the EASD, the American Diabetes Association, the American Association
of Clinical Endocrinologists and the American College of
Endocrinology.
About the sanofi-aventis Diabetes Division
Sanofi-aventis strives to be a 360 degree partner delivering
innovative and integrated solutions for people living with diabetes.
The Company currently has insulin products that are also available as
injection pens for people with type 1 or type 2 diabetes. Following
the formation of its Diabetes Division, sanofi-aventis has agreements
with other companies for the development of blood glucose monitoring
solutions and the potential first regenerative treatment for
diabetes. Investigational compounds also in the pipeline include the
once-daily injectable GLP-1 agonist lixisenatide as monotherapy and
in combination with basal insulin as well as long-acting insulin
analogs.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company,
discovers, develops and distributes therapeutic solutions to improve
the lives of everyone. Sanofi-aventis is listed in Paris  and in New
York . For more information, please visit:
http://www.sanofi-aventis.com.

Contact:

CONTACT: Media Contacts: Susan Brooks, US: Tel: +1-908-981-6566,
E-mail:Susan.Brooks@sanofi-aventis.com; Yanyan Chang, Global Diabetes
Division:Tel: +49-69-305-22283, E-mail:
Yanyan.chang@sanofi-aventis.com; MarisolPeron, Corporate Media
Relations: Tel: +33(0)-1-53-77-45-02, Mobile :+33(0)6-08-18-94-78,
E-mail: marisol.peron@sanofi-aventis.com

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