Sanofi-aventis: Adding Lantus(R) to Oral Antidiabetic Drug Therapy Further Reduced Blood Sugar in Patients With Type 2 Diabetes

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

Findings Presented at European Association for the Study of Diabetes (EASD) 46th Annual Meeting

PARIS, September 20, 2010 - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today
results of two studies presented at the European Association for the Study of
Diabetes (EASD) 46th Annual Meeting in Stockholm, Sweden. The first pooled
analysis using patient-level data from randomized clinical trials
demonstrated that adding Lantus(R) (insulin glargine [rDNA] injection) to
patients with type 2 diabetes, uncontrolled on oral antidiabetic drug therapy
(OADs), was associated with a greater reduction in A1C levels and lower
incidence of any hypoglycemia versus all comparators (OADs, NPH, lispro,
premix).

In the second pooled analysis of clinical studies, "patients
with type 2 diabetes, who used Lantus(R) as monotherapy or added it to one
baseline oral antidiabetic agent, demonstrated a greater reduction in A1C
with lower risk of hypoglycemia than those taking two OADs, with a most
significant reduction when Lantus(R) was added to metformin alone versus
other OADs [sulfonylurea alone or sulfonylurea plus metformin]," said Dr.
Jack Leahy of the University of Vermont College of Medicine and principal
investigator of one of the studies.

Better Efficacy and Goal Attainment Demonstrated with Insulin
Glargine versus All Comparators[i]

"Efficacy and Goal Attainment with Insulin Glargine vs
Comparators" [presentation number 976]: This pooled analysis looked at nine
clinical studies where insulin-naive patients with type 2 diabetes
uncontrolled on OADs were randomized to add Lantus(R) (n=1,462) or
comparators (OADs, NPH, lispro or premix; n=1,476) to their treatment
regimen. Results showed that initiating Lantus(R) in patients uncontrolled on
OADs was associated with better efficacy and goal attainment overall versus
all comparators across the A1C continuum and when compared to OADs when
baseline A1C was greater than or equal to 8.0 percent.

Outcomes showed:

    - A1C reductions at week 24 were greater with Lantus(R) versus
      all comparators (p<0.001)

    - Efficacy across A1C categories were similar for insulin
      comparators

    - Hypoglycemia rates (any) were lower with Lantus(R) versus
      other insulin comparators (Lantus vs. NPH, p=0.032, Lantus vs. lispro,
      p=<0.001, Lantus vs. premix, p=004)

    - Hypoglycemic event rates (any) were higher for Lantus versus
      OADs (p<0.001), although rates of severe hypoglycemia were similar
      between the two groups.

Significant Improvement in A1C Found Independent of Baseline
Treatment Regimen[ii]

"Clinical Outcomes after Basal Insulin Initiation Correlate
with Baseline Oral Antidiabetic Drug Therapy: A Pooled Analysis of Clinical
Trial Data" [presentation number 960]: This analysis included data from 11
prospective randomized controlled trials of Lantus(R) with or without OADs in
adults with type 2 diabetes. The analysis compared patients given Lantus(R)
(n=2,171) who were taking zero or one OAD at baseline (low use; 1.8% and
45.2%, respectively) with those taking two OADs (52.2%) and patients on
metformin only (8.5%) with those on sulfonylurea only (36.5%) or metformin
and sulfonylurea (49.9%) at baseline.

Outcomes showed:

    - At week 24, the reduction in A1C was greatest among patients
      given Lantus(R) with low baseline OAD use (0/1 OADs) (p=0.0198) and
      among those who were taking Lantus and metformin only (p=0.0009)

    - Patients given Lantus(R) with low baseline OAD use had
      significantly lower rates of symptomatic hypoglycemia versus those
      taking two OADs (p=0.0009)

    - Patients given Lantus(R) who were taking only metformin had
      lower rates of hypoglycemia than those taking sulfonylurea or metformin
      plus sulfonylurea (p<0.0001) despite higher insulin doses (53 versus
      37.5 versus 38.8 U)

Important Safety Information for Lantus(R)

Do not take Lantus(R) if you are allergic to insulin or any of
the inactive ingredients in Lantus(R).

You must test your blood sugar levels while using insulin,
such as Lantus(R). Do not make any changes to your dose or type of insulin
without talking to your healthcare provider. Any change of insulin should be
made cautiously and only under medical supervision.

Do NOT dilute or mix Lantus(R) with any other insulin or
solution. It will not work as intended and you may lose blood sugar control,
which could be serious. Lantus(R) must only be used if the solution is clear
and colorless with no particles visible. Do not share needles, insulin pens
or syringes with others.

The most common side effect of insulin, including Lantus(R),
is low blood sugar (hypoglycemia), which may be serious. Some people may
experience symptoms such as shaking, sweating, fast heartbeat, and blurred
vision. Severe hypoglycemia can be dangerous and can cause harm to your heart
or brain. It may cause unconsciousness, seizures, or death. Other possible
side effects may include injection site reactions, including changes in fat
tissue at the injection site, and allergic reactions, including itching and
rash. In rare cases, some allergic reactions may be life threatening. Tell
your doctor about other medicines and supplements you are taking because they
can change the way insulin works. Before starting Lantus(R), tell your doctor
about all your medical conditions including if you have liver or kidney
problems, are pregnant or planning to become pregnant, or are breast-feeding
or planning to breast-feed.

Indications and Usage

Prescription Lantus(R) is a long-acting insulin used to treat
adults with type 2 diabetes and adults and children (6 years and older) with
type 1 diabetes for the control of high blood sugar. It should be taken once
a day at the same time each day to lower blood glucose. Do not use Lantus(R)
to treat diabetic ketoacidosis.

Lantus(R) SoloSTAR(R) is a disposable prefilled insulin pen.

For full prescribing information for Lantus(R), please visit
www.Lantus.com or call +1-800-633-1610.

Important Safety Information for Apidra(R)

Do not use Apidra(R) during a low blood sugar reaction
(hypoglycemia) or if you are allergic to any of the ingredients in Apidra(R).

You must test your blood sugar levels while using insulin,
such as Apidra(R). Do not make any changes to your dose or type of insulin
without talking to your healthcare provider. Any change of insulin should be
made cautiously and only under medical supervision. Apidra(R)
must only be used if the solution is clear and colorless with no particles
visible. Do not share needles, insulin pens or syringes with others.

Apidra(R), when given by injection under the skin, should not
be mixed with insulins other than NPH. Do not mix Apidra with any insulin
when used in the pump or for intravenous administration.

The most common side effect of insulin, including Apidra, is
low blood sugar (hypoglycemia), which may be serious. Some people may
experience symptoms such as shaking, sweating, fast heartbeat, and blurred
vision. Severe hypoglycemia can be dangerous and can cause harm to your heart
or brain. It may cause unconsciousness, seizures, or death. Other possible
side effects may include low blood potassium, injection site reactions, such
as changes in fat tissue at the injection site, and allergic reactions, such
as itching and rash. Less common, but potentially more serious or
life-threatening, is generalized allergy to insulin, including anaphylactic
reactions.

Tell your doctor about other medicines and supplements you are
taking because they can change the way insulin works. Before starting
Apidra(R), tell your doctor about all your medical conditions including if
you have liver or kidney problems, are pregnant or planning to
become pregnant, or are breast-feeding or planning to breast-feed.

Indications and Usage

Prescription Apidra(R) is for adults with type 2 diabetes or
adults and children (4 years and older) with type 1 diabetes to improve blood
sugar control. Apidra(R) is usually used with a longer-acting insulin. When
used as a mealtime insulin, Apidra(R) should be given within 15
minutes before or within 20 minutes after starting a meal.

Apidra(R) SoloSTAR(R) is a disposable prefilled insulin pen.

For full prescribing information for Apidra(R), please visit
www.Apidra.com or call +44(0)800-633-1610.

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. It is
estimated that approximately 285 million adults worldwide are living with the
disease and this number is expected to rise to a staggering 438 million
within 20 years[iii],[iv]. It is estimated that nearly 24 million Americans
have diabetes, including an estimated 5.7 million who remain undiagnosed[v]
At the same time, according to NHANES data from 2003-2004, approximately 40
percent of those diagnosed with diabetes did not achieve the blood sugar
control target of A1C <7 percent recommended by the ADA[vi]. The A1C test
measures average blood glucose levels over the past two-to-three-month
period.

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, including Lantus(R), Apidra(R) and
Insuman(R) (outside the US)– Lantus(R) and Apidra(R) are also available as
injection pens (Lantus(R) SoloSTAR(R) and Apidra(R) SoloSTAR(R)). Also
available in some countries (outside the US) is ClikSTAR(R), a reusable
insulin injection pen for Lantus(R) or Apidra(R) 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 a 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.

US.GLA.10.08.098

    [i] Banerji, M.A., "Efficacy and Goal Attainment with Insulin Glargine vs
        Comparators." Presented at the European Association for the Study of
        Diabetes 46th Annual Meeting, presentation number 976,2010.

    [ii] Leahy, J. "Clinical outcomes after basal insulin initiation
         correlate with baseline oral antidiabetic drug therapy: a pooled
         analysis of clinical trial data." Presented at the Association for
         the Study of Diabetes 46th Annual Meeting, presentation number 960,
         2010.

    [iii] IDF Diabetes Atlas.Global Burden.Aug.2010/Page 1/Lines 26-27

    [iv] IDF Diabetes Atlas.Global Burden.Aug.2010/Page 1/Lines 29-30

    [v] CDC.DiabetesFactSheet.2007/Pg 5/Line 20]

    [vi]Ford.DiabetesCare.Jan.2008/Pg 103/Table 1

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

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