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

By Sanofi-aventis, PRNE
Sunday, September 19, 2010

Phase III Study Results Also Demonstrated the Therapy had Acceptable Safety Profile

PARIS, September 20, 2010 - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) 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 (EURONEXT: SAN) and in
New York (NYSE: SNY). For more information, please visit:
www.sanofi-aventis.com.

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

Clinical Trials / Medical Discoveries News

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