More Patients with Type 2 Diabetes Reach HbA[1c] Target with Apidra® on top of Lantus® Than with Twice-daily Aspart Premixed Insulin

Paris (ots/PRNewswire) -

- First Randomized Controlled Trial to Show That Basal Plus
Regimen Provides more Effective Glycemic Control with Less
Hypoglycemia Than with Aspart Premixed Insulin

Sanofi announced today data presented at the 47th Annual Meeting
of the European Association for the Study of Diabetes to show that
adding mealtime Apidra(R) (insulin glulisine) to Lantus(R) (insulin
glargine) is more efficacious, with less hypoglycemia, than
introducing aspart premixed insulin twice daily.

"Comparison of 3 intensified insulin regimens added to oral
therapy for type 2 diabetes: twice-daily aspart premixed vs glargine
plus 1 prandial glulisine or stepwise addition of glulisine to
glargine" [ABSTRACT 3515]

Results from the All-to-Target trial show that people with type 2
diabetes, whose treatment with oral antidiabetic therapy is
unsuccessful, may advance to intensified insulin treatment. Adding
mealtime Apidra(R) insulin to a Lantus(R) basal-insulin regimen is an
effective treatment strategy for insulin intensification, sustaining
continuity of care throughout the duration of the disease.

The stepwise addition of Apidra(R) prandial (mealtime) doses to
Lantus(R) treatment can also be an effective introduction to a full
basal-bolus regimen.

All-to-Target is a 60-week, randomized, open-label study comparing
efficacy, hypoglycemia rates and body weight in people with type 2
diabetes treated with three different insulin regimens: premixed
70/30 protamine-aspart/aspart twice daily (n = 192); Lantus(R) plus
one prandial dose of Apidra(R) (n = 189); and Lantus(R) plus stepwise
addition of Apidra(R) (n = 191).

Significantly more people reached target HbA1c<7% with one
mealtime dose of Apidra(R) plus Lantus (49%, p<0.025), or stepwise
addition of Apidra(R) at mealtimes (45%, p<0.05), than those on
premixed insulin (39%). Furthermore, significantly more people on one
mealtime dose of Apidra(R) plus Lantus(R) (24%, p<0.05) or stepwise
addition of Apidra(R) at mealtimes (24%, p<0.05) achieved target
HbA1c with no hypoglycemia vs. those on aspart premixed insulin
(14%).

People on the Basal Plus regimen experienced fewer hypoglycemic
events (blood glucose <50 mg/dL [2.8 mmol/L] + symptoms per patient
year [Glarg +1 glulisine = 0.8+/-0.2; p>0.001 and Glarg+0-3 glulisine
= 0.9+/-0.2; p<0.001] vs. premixed [1.9+/-0.3]).

The Basal Plus approach not only emulates physiological insulin
secretion but also allows the flexibility of separate adjustment of
basal and prandial insulin doses.

Commenting on the results, study investigator Dr Matthew Riddle,
Oregon Health & Sciences University, said: "Adding a single injection
of prandial insulin to titrated basal insulin is a logical and
patient-friendly way to intensify therapy for type 2 diabetes. Now we
have shown this approach was as effective, yet caused less
hypoglycemia than twice-daily premixed insulin. In addition, this
basal plus one prandial injection method compared favorably as a
regimen permitting full basal-bolus treatment."

First data from the trial have previously been presented at the
American Diabetes Association's 71st Scientific Sessions, 2011.

About the Sanofi Diabetes Division

Sanofi strives to help people manage the complex challenges of
diabetes by delivering innovative, integrated and personalized
solutions. Driven by valuable insight that comes from listening to
and engaging with people living with diabetes, the Company is forming
partnerships to offer diagnostics, therapies, services and devices.
Sanofi markets both injectable and oral medications for people with
type 1 or type 2 diabetes. Investigational compounds in the pipeline
include an injectable GLP-1 agonist being studied as a single agent,
in combination with basal insulins, and/or in combination with oral
antidiabetic agents.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers,
develops and distributes therapeutic solutions focused on patients'
needs. Sanofi has core strengths in the field of healthcare with
seven growth platforms: diabetes solutions, human vaccines,
innovative drugs, rare diseases, consumer healthcare, emerging
markets and animal health. Sanofi is listed in Paris and in New York
.

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 projections and estimates and their
underlying assumptions, statements regarding plans, objectives,
intentions and expectations with respect to future financial results,
events, operations, services, product development and potential, 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's 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, 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 EMA, 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 labeling 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, the
Group's ability to benefit from external growth opportunities as well
as those discussed or identified in the public filings with the SEC
and the AMF made by Sanofi, including those listed under "Risk
Factors" and "Cautionary Statement Regarding Forward-Looking
Statements" in Sanofi's annual report on Form 20-F for the year ended
December 31, 2010. Other than as required by applicable law, Sanofi
does not undertake any obligation to update or revise any
forward-looking information or statements.

Contacts: Global Diabetes Division Communications
Dr. Tilmann Kiessling T. +49(0)172-61-59-291
[email protected]

Rückfragehinweis:
.

OTS-ORIGINALTEXT PRESSEAUSSENDUNG UNTER AUSSCHLIESSLICHER INHALTLICHER VERANTWORTUNG DES AUSSENDERS - WWW.OTS.AT | PRN

print