Results Presented at the ADA's Annual Scientific Sessions
SAN FRANCISCO, June 7 /PRNewswire-FirstCall/ -- Sanofi-aventis
announced today that the results of the dose-finding study for its new
injectable diabetes compound AVE0010, a GLP-1 agonist, were presented at
the American Diabetes Association's (ADA) 68th Annual Scientific Sessions
meeting in San Francisco, California.
The study found that AVE0010 was well tolerated and significantly
improved glycemic control versus placebo in type 2 diabetes patients
inadequately controlled with metformin alone. The once daily regimen
demonstrated a clear dose response with a similar HbA1c reduction to twice
daily regimen. AVE0010 was also found to be associated with weight loss and
reductions in postprandial glucose.
"The results of the once daily AVE0010 regimen are very promising and
this new GLP-1 agonist has a potential to become an important addition to
the treatment armamentarium for type 2 diabetes," said Robert Ratner, from
the MedStar Research Institute Washington DC, Principal Investigator of the
dose-finding study.
About the Study
The dose-finding study involved 542 type 2 diabetes patients
inadequately controlled on metformin monotherapy (1.6-1.9 g/day). In this
double-blind study, patients were randomized to receive for 13 weeks,
either AVE0010 subcutaneously at the doses of 5, 10, 20 and 30 micron(g)
once daily or twice daily, or placebo. The primary endpoint was change in
HbA1c from baseline. Secondary endpoints included weight change and 2-hour
post-prandial plasma glucose (PPG).
Baseline characteristics were similar among groups in terms of mean age
(56 +/-9 years), diabetes duration (6.6 +/-5 years), HbA1c (7.5 +/-0.6%)
and Body Mass Index (31.9 +/-4 kg/m2). Despite mildly elevated baseline
HbA1c, the results of the study demonstrated a highly statistically
significant dose response with a net decrease in mean HbA1c from baseline
subtracted from placebo from -0.28 to -0.57% for once daily dosing and from
-0.47 to -0.69% for twice daily dosing.
At the conclusion of the study, the percentages of patients with HbA1c
<7% ranged from 47 to 69% for once daily dosing and from 51 to 77% for
twice daily dosing compared to 32% for placebo.
AVE0010 was also associated with weight decreases ranging from -2 to
-3.5 kg (5 and 30 micron(g) once daily) and from -2.1 to -3.9 kg (5 and 30
micron(g) twice daily) versus -1.9 kg with placebo. Decreases in mean
2-hour PPG ranged from -36 to -83 mg/dL in the AVE0010 groups versus -8
mg/dL with placebo.
In addition, few patients discontinued treatment due to adverse events
(1.8-11.1% with once daily versus 1.8% with placebo).
Adverse events included transient dose-dependent nausea (from 7,3 to
33,3% with 5 micron(g) once daily and 30 micron(g) twice daily,
respectively versus 4.6% with placebo). No cases of severe hypoglycemia
were reported.
The Phase III clinical trial program for AVE0010 started in May 2008
and is planned to involve more than 3,800 patients.
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).
Forward Looking Statements
This press release contains forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts.
These statements include product development, product potential projections
and estimates and their underlying assumptions, statements regarding plans,
objectives, intentions and expectations with respect to future events,
operations, products and services, and statements regarding future
performance. Forward-looking statements are generally identified by the
words "expects," "anticipates," "believes," "intends," "estimates," "plans"
and similar expressions. Although sanofi-aventis' management believes that
the expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking information and
statements are subject to various risks and uncertainties, many of which
are difficult to predict and generally beyond the control of
sanofi-aventis, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and uncertainties
include among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMEA, regarding
whether and when to approve any drug, device or biological application that
may be filed for any such product candidates as well as their decisions
regarding labelling and other matters that could affect the availability or
commercial potential of such products candidates, the absence of guarantee
that the products candidates if approved will be commercially successful,
the future approval and commercial success of therapeutic alternatives as
well as those discussed or identified in the public filings with the SEC
and the AMF made by sanofi-aventis, including those listed under "Risk
Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in
sanofi-aventis' annual report on Form 20-F for the year ended December 31,
2007. Other than as required by applicable law, sanofi-aventis does not
undertake any obligation to update or revise any forward-looking
information or statements.
U.S. Media Contact:
Carrie Melia
Carrie.melia@sanofi-aventis.com
908-981-6486
Sanofi-aventis: http://www.sanofi-aventis.us
Media Relations: Tel. : 908-981-6567
E-mail: us.media-relations@sanofi-aventis.com
Investor Relations: Tel. : 908-981-5560
E-mail: IR@sanofi-aventis.com
SOURCE sanofi-aventis
 back to top
Related links:
http://www.sanofi-aventis.us
http://www.sanofi-aventis.com/
http://www.prnewswire.com/comp/232375.html /
CONTACT:
U.S. Media Contact, Carrie Melia,
+1-908-981-6486, Carrie.melia@sanofi-aventis.com, or Media
Relations, +1-908-981-6567,
us.media-relations@sanofi-aventis.com, or Investor Relations,
+1-908-981-5560, IR@sanofi-aventis.com
|
