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Superior Efficacy-dose Ratio for Lantus(R) Over detemir

Paris (ots/PRNewswire)

- 76% Higher Dose of Insulin detemir Needed to Achieve Similar,
Well Tolerated Glycemic Control Versus Lantus(R)
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today
results of a head-to-head study providing further evidence on the
efficacy of once-daily, 24-hour basal insulin Lantus(R) (insulin
glargine [rDNA] injection) compared to twice-daily insulin detemir.
The study was presented during the 45th Annual Meeting of the
European Association for the Study of Diabetes (EASD) in Vienna.
To view the Multimedia News Release, please click:
http://www2.prnewswire.com/mnr/sanofiaventis/40283/
In the head-to-head, randomised, non-inferiority controlled
clinical trial of 964 patients, patients taking Lantus(R) required an
average daily dose of 43.5 units to achieve the primary endpoint of
HbA1c below 7% without symptomatic hypoglycaemia compared to patients
on insulin detemir, who received 76.5 units - an increase of 76%
(p<0.001). Despite lower doses of insulin in the glargine group,
Lantus(R) once-daily and insulin detemir twice-daily resulted in
similar improvements in glycemic control (HbA1c) and a similar risk
of hypoglycaemia (primary endpoint: 27.5% vs 25.6%, p=0.52). Patients
in the Lantus(R) arm of the study also achieved significantly lower
fasting blood glucose (-63.1 mg/dL Lantus(R) vs -57.7 mg/dL,
p<0.001).
"This study demonstrated that for insulin-naive patients with
type 2 diabetes, initiating insulin therapy with once-daily glargine
achieved the same glycemic control as twice-daily detemir, with
somewhat more weight gain, but lower insulin doses", stated Study
Investigator Hertzel Gerstein, Professor of Diabetes Medicine,
Faculty of health sciences, Hamilton, Canada.
In the study, patients taking Lantus(R) once-daily reported a
significantly greater treatment satisfaction over insulin detemir
twice-daily, with over 50% less drop-outs (4.6% vs 10.1%, p=0.001).
Discontinuations in patients taking insulin detemir were primarily
due to adverse events, including skin reactions. Whilst a similar
rate of overall hypoglycaemia and nocturnal hypoglycaemia was
observed in both arms, patients on Lantus(R) once-daily experienced
less daytime hypoglycaemia as compared to insulin detemir (1.06 vs
1.64 events per patient year, p=0.046). Patients on insulin detemir
experienced less weight gain (0.6 vs 1.4 kg, difference 0.77 kg,
p<0.001).
About the Lantus(R) vs. insulin detemir study(1)
In the study, a total of 964 insulin-naive patients were
examined. Patients were between 40 to 75 years of age and had type 2
diabetes for at least 1 year with sub-optimal blood glucose control
using glucose-lowering drugs.
Patients were randomised and treated with Lantus(R) once daily,
at either dinner or bedtime, or insulin detemir twice daily, both at
breakfast and before dinner, along with stable doses of metformin.
Thiazolidinedione treatment was halted as of insulin randomisation,
but insulin secretagogues were continued or discontinued at the
investigator's discretion.
For both insulins, the starting daily dose was 0.2 U/kg, which
was then titrated every 2 days by 2 units to obtain a Fasting Plasma
Glucose (FPG) of <100 mg/dL (5.6 mmol/L). At baseline, mean age was
58.4 plus or minus 8.3 yrs (mean plus or minus standard deviation),
mean type 2 diabetes duration was 9.9 plus or minus 5.8 years, mean
FPG was 189.2 plus or minus 48.7 mg/dL, and mean HbA1c was 8.7 plus
or minus 0.9%. 27.5% and 25.6% of patients reached the primary
endpoint of HbA1c <7% without confirmed hypoglycaemia. Change from
baseline to endpoint HbA1c was similar with Lantus(R) and insulin
detemir (-1.46 plus or minus1.09 and -1.54 plus or minus 1.11%;
p=0.149), endpoint HbA1c levels were 7.2 plus or minus 0.9% and 7.1
plus or minus 0.9% respectively. Endpoint FBG was lower with
Lantus(R) versus insulin detemir (108 plus or minus 24 vs 119 plus or
minus 32mg/dL).
There was a lower rate of daytime symptomatic hypoglycaemia
confirmed by PG less than or equal to 56 mg/dL (3.1 mmol/L) with
Lantus(R)  treatment vs. insulin detemir (1.06 plus or minus 3.13 vs.
1.64 plus or minus  5.42 events/patients-year, p=0.046). Frequencies
of asymptomatic, overall symptomatic, nocturnal symptomatic and
severe hypoglycaemia were comparable between treatment groups.
Significantly more patients in the insulin detemir group terminated
the study early (10.1 vs. 4.6%, p=0.001), which was mostly related to
skin reactions. Limited weight gain in both groups, although compared
with the glargine group, patients on insulin detemir experienced less
weight gain (0.6 versus 1.4kg, difference 0.77kg p<0.001).
About Lantus(R)
Lantus(R) is indicated for once-daily subcutaneous administration
in the treatment of adult patients with type 2 diabetes mellitus who
require basal (long-acting) insulin for the control of hyperglycaemia
and for adult and paediatric patients (6 years and older) with type 1
diabetes mellitus. Lantus(R) demonstrates a peakless and sustained
concentration/time profile over 24h thus reducing the risk of
hypoglycaemia and allowing a constant and high efficacy over 24h with
one single day injection. Lantus(R) is the number one prescribed
insulin worldwide.
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 and this number is expected to rise to a staggering 350
million within 20 years. It is estimated that nearly 24 million
Americans have diabetes, including an estimated 5.7 million who
remain undiagnosed. In addition, about 40 percent of those diagnosed
are not achieving the blood sugar control target of HbA1c < 7 percent
recommended by the ADA. The HbA1c test measures average blood glucose
levels over the past two- to three-month period.
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, 2008. Other than as required by
applicable law, sanofi-aventis does not undertake any obligation to
update or revise any forward-looking information or statements.
Reference:
(1) S.G.H. Swinnen, et al. Abstract 966. "Once-daily insulin
glargine requires a significantly lower dose than insulin detemir
twice-daily to achieve good glycaemic control in patients with type 2
diabetes failing oral therapy"

Contact:

Media contact: Anna Radjanova, Tel: +33-(0)6-07-28-61-63, E-mail:
anna.radjanova@sanofi-aventis.com

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