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

Paris (ots/PRNewswire)

Sanofi-aventis  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
http://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
http://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  and in New
York . For more information, please visit:
http://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

Contact:

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

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