ROME, Sept. 10 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today
that results presented at the 44th annual meeting of the European
Association for the Study of Diabetes (EASD) demonstrated that a
basal-bolus insulin regimen with Lantus(R) (insulin glargine [rDNA origin]
injection) once daily (basal insulin) and rapid-acting Apidra(R) (insulin
glulisine [rDNA origin] injection) at mealtime (bolus insulin) resulted in
significant A1C reductions from baseline as compared to pre-mixed insulin
in people with type 2 diabetes.
In the GINGER study ("52-Week, Open, Randomized, Multinational,
Multicenter Clinical Trial Comparing Insulin Glulisine in Combination With
Insulin Glargine in an Intensified Insulin Regimen to a Two-Injection
Conventional Insulin Regimen in Type 2 Diabetes Mellitus Patients With Poor
Glycemic Control Pretreated With a Two-Injection Conventional [Pre-Mixed]
Insulin Therapy"), the overall A1C change from baseline to endpoint with
Lantus(R) and Apidra(R) was 1.3% versus 0.8% with pre-mix. The number of
patients who reached A1C <7.0% at endpoint was significantly higher with
Lantus(R) and Apidra(R) when compared to pre-mixed insulin (68 [47%] versus
43 [28%]; p=0.0004).
Patients on intensified insulin Lantus(R) and Apidra(R) therapy
experienced on-treatment hypoglycemic events at a rate of 14.0
events/patient-year, vs. 18.5 events/patient-year in the premix arm
(p=0.2385). This finding was not statistically significant. Compared with
patients on pre-mixed insulin, patients were treated with higher mean daily
insulin doses at endpoint with the Lantus(R)/Apidra(R) treatment therapy
(98.0 +/- 48.7 versus 91.3 +/- 44.3 U; p=0.0003) and showed slightly
greater weight gain (+3.6 +/- 4.0 versus +2.2 +/- 4.5 kg; p=0.0073).
About the GINGER Study
The GINGER study was a 52-week, open, randomized, multinational,
multicenter clinical trial comparing the efficacy and safety of mealtime
rapid-acting Apidra(R) and once-daily Lantus(R) (n=153) in a basal-bolus
regimen with an optimized conventional therapy of two subcutaneous
injections per day of pre-mixed insulin (n=157) in type 2 diabetes patients
inadequately controlled with their previous pre-mixed insulins. At
baseline, the characteristics of participants (49% female) were (mean +/-
SD): age, 61 +/- 8 years; BMI, 30.1 +/- 3.7 kg/m(2); diabetes duration, 13
+/- 6 years; and insulin use, 5 +/- 4 years.
Additional study findings showed that an intensified insulin therapy
with Lantus(R) and Apidra(R) versus a conventional therapy with pre-mixed
insulin resulted in a significant reduction of A1C (A1C change from
baseline to endpoint D: -0.5%; p=0.0001; 95% confidence interval [-0.71,
-0.24]; ANCOVA adjusted for country, metformin and baseline). The
Lantus(R)/Apidra(R) treatment therapy provided significant reductions in
mean daytime blood glucose (p=0.0033) and postprandial blood glucose
(p<0.0001) versus pre-mixed insulins.
About Diabetes
Diabetes is a chronic, widespread condition in which the body does not
produce or properly use insulin -- the hormone needed to transport glucose
(sugar) from the blood into the cells of the body for energy. More than 230
million people worldwide are living with the disease. This number is
expected to rise to a staggering 350 million within 20 years.(1)
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 financial 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 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.
(1) The International Diabetes Federation (IDF), Unite for Diabetes
Campaign key messages. Available at:
http://www.unitefordiabetes.org/youth/files/UNR_key_messages_20060828.pdf
(Due to length of the URL, paste copy and paste link into your browser.
Remove the space if one exists). Accessed March 28, 2007
U.S. Media Contacts:
Susan Brooks
Susan.Brooks@sanofi-aventis.com
908.981.6566
Carrie Melia
Carrie.Melia@sanofi-aventis.com
908.981.6486
US.GLA.08.08.034
SOURCE sanofi-aventis
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Related links:
http://www.sanofi-aventis.com
http://www.sanofi-aventis.us
http://www.unitefordiabetes.org/youth/files/UNR_key_messages_20060828.pdf
CONTACT:
U.S. Media, Susan Brooks,
Susan.Brooks@sanofi-aventis.com, +1-908-981-6566, or Carrie
Melia, Carrie.Melia@sanofi-aventis.com. +1-908-981-6486, both of
sanofi-aventis
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