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Sanofi Aventis : New Study Results Support the "Basal Plus" Strategy With LANTUS(R) and APIDRA(R) to Improve Blood Sugar Control in Patients With Type 2 Diabetes

Paris (ots/PRNewswire)

- Abstracts 185 and 1112
Sanofi-aventis, a world leader in diabetes care, announced
results from two randomized clinical studies presented at the
European Association for the Study of Diabetes (EASD) 44th Annual
Meeting demonstrating that the "basal plus" insulin strategy with
LANTUS(R) (insulin glargine (rDNA origin) injection) once daily
(basal insulin) and APIDRA(R) once daily (prandial insulin) (insulin
glulisine (rDNA origin) injection) administered at the main meal
(defined by the highest postprandial blood glucose level) improve
blood glucose levels in patients with type 2 diabetes after basal
insulin optimisation.
In the ELEONOR (Optimising basal plus insulin therapy in type 2
diabetes by telecare assistance for self-monitoring of blood glucose)
and OPAL (Adding a single dose of insulin glulisine at breakfast or
main meal to basal insulin and oral antidiabetic therapy) clinical
studies, patients previously treated with LANTUS(R) and oral diabetes
medications achieved significantly improved glycaemic control by
implementing a "basal plus" regimen - adding one injection of
APIDRA(R) at the main meal of the day. In the ELEONOR study, the
addition of one APIDRA(R) injection resulted in a further A1C drop of
0.7-0.8%. In the OPAL study, A1C scores improved, significantly
dropping 0.4% from baseline to endpoint in both patients that were
administered APIDRA(R) at breakfast and patients who were
administered APIDRA(R) at main meal.
"With so many people living with diabetes not reaching their A1C
goals, we're always looking for new ways to help manage blood glucose
levels," said Dr. Del Prato, Professor of Endocrinology and
Metabolism and Chief of the Section of Diabetes at the School of
Medicine, University of Pisa, Italy. "The results from ELEONOR and
OPAL show us that a basal plus strategy is an option for insulin
intensification for Type 2 Diabetes insufficiently controlled despite
optimized titration of LANTUS(R) combined with oral antidiabetic drug
therapy."
The ELEONOR study also confirmed that in a large proportion of
patients with secondary failure to oral antidiabetic agents, both
Telecare and standard blood glucose monitoring can be used for
initiation and titration of the "basal/basal plus" strategy. In the
Telecare arm of the study, 50.6% of patients reached an A1C score of
less than or equal to 7%, whereas in the standard blood glucose
monitoring arm, 54.6% of patients similarly achieved an A1C score of
less than or equal to 7%.
About the ELEONOR Study
ELEONOR was an open-label, multicentre, randomised, controlled,
parallel-group study of 200 patients (54% male, 46% female) with poor
glycaemic control (A1C 8.9plus or minus0.9%) on one or more oral
hypoglycaemic agents. Following a 4-week run-in period, all patients
began treatment with LANTUS(R) (Visit 2) and titrated to achieve
blood glucose less than or equal to5.5 mmol/L. At LANTUS(R)
initiation (baseline), patients were randomised to either Telecare
(allowing electronic transfer of blood glucose readings,) or standard
blood glucose monitoring to identify the highest postprandial peak
and APIDRA(R) dose adjustment by phone, as deemed necessary by the
investigators, or dose adjustment at each visit, respectively. After
8-16 weeks of LANTUS(R), patients with blood glucose less than or
equal to7.0 mmol/L in both groups added one dose of APIDRA(R) at the
meal with the highest postprandial blood glucose; this treatment was
maintained for 24 weeks. The primary objective was to compare
Telecare with standard blood glucose in terms of A1C change.
Secondary endpoints included blood glucose profiles, weight change,
size of insulin dose and safety (including hypoglycaemia).
Preliminary results are reported without lifting the study blinding.
Additional study findings showed that during LANTUS(R) titration,
A1C improved with both blood glucose monitoring approaches by 1%. One
APIDRA(R) injection was added to 88% of patients reaching target
blood glucose (Breakfast 7%; Lunch 43%; Supper 50%), resulting in a
further 0.7-0.8% A1C drop in both groups (endpoint A1C: 7.1 plus or
minus -0.7 versus 7.0 plus or minus 0.7%; both p<0.0001 versus
LANTUS(R) alone) with 50.6% and 54.6% of patients, respectively,
reaching A1C less than or equal to7.0% at endpoint. With LANTUS(R),
fasting blood glucose decreased in both groups (from 11.7  plus or
minus 3.1 to 6.0 plus or minus 1.0 and from 11.6 plus or minus 3.3
to 6.1 plus or minus 1.1 mmol/L, respectively; both p<0.0001) with no
further  change after APIDRA(R) initiation (6.4 plus or minus 1.6
versus 6.3 plus or  minus 1.6 mmol/L). There was no difference in
weight changes (+0.4 plus or  minus 3.0 versus +0.1 plus or minus 5.0
kg) in LANTUS(R) (29 plus or minus  16 versus 28plus or minus 17 U/d)
or APIDRA(R) (8.3 plus or minus 7.1  versus 8.1 plus or minus 8.1
U/d) dose. Five episodes of severe  hypoglycaemia were experienced by
4 patients.
About the OPAL Study
OPAL was a 26-week, randomized, multicentre study conducted in
316 patients with type 2 diabetes, who were poorly controlled (A1C
>6.5-9.0%) on previous treatment with LANTUS(R)+ oral hypoglycaemic
agents. Patients (blood glucose less than or equal to 6.7 mmol/L
(less than or equal to120 mg/dL)) were stratified by the main meal
(breakfast, lunch or dinner), determined by the highest postprandial
blood glucose level, and randomised to APIDRA(R) once daily +
LANTUS(R) once daily + oral hypoglycaemic agents (LANTUS(R) as basal
insulin) with APIDRA(R) given at breakfast (n=162) or main meal
(n=154). The primary aim was to demonstrate equivalence in baseline
to endpoint A1C change between both arms.
Baseline demographics for the overall, breakfast and main meal
groups were similar. Patients had an average age >60 years, obese
(>30 kg/m2) and had suboptimally controlled type 2 diabetes
management (blood glucose ~6 mmol/L and A1C ~7.3%). Additional study
findings showed that overall A1C significantly improved from baseline
to endpoint (p<0.0001), while both arms were equivalent in terms of
A1C change (equivalence margin=0.4%). Blood glucose values improved
significantly within each arm for most pre- and post-meal timepoints.
Overall, 30.7% of patients achieved A1C less than or equal to 6.5%
(27.8% breakfast and 33.8% main meal arms; p=0.21). For those
patients with baseline A1C>7.0%, 44.1% achieved A1C less than or
equal to7.0% at endpoint (36.5% breakfast and 52.2% main meal arms;
p=0.028). Mean LANTUS(R) dose was unchanged (baseline versus
endpoint: 31 versus 32 U/day breakfast and 27 versus 27 U/day main
meal arms), whereas APIDRA(R) dose increased (starting dose of 5
U/day versus 11 and 12 U/day, respectively). The rate of on-treatment
hypoglycaemia (blood glucose less than or equal to 3.3 mmol/L (less
than or equal to 60 mg/dL)) was 3.21 events/patient year for the
overall group (2.72 and 3.69 events/patient year for the breakfast
and main meal arms, respectively).
Additional details about the ELEONOR and OPAL data are
included in the study abstracts, available at EASD.org.
You will find the full information about LANTUS(R), APIDRA(R) and
diabetes in the complete text of the Press Release on site:
http://en.sanofi-aventis.com/press/press_releases/2008/news_list_
2008.asp
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).
PARIS, September 10 /PRNewswire/ --

Contact:

Contact: Anna Radjanova, MD, Tel: +33-6-07-28-61-63, E-mail:
anna.radjanova@sanofi-aventis.com

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