Data Show Sanofi's Lyxumia® Added to Basal Insulin Lowered Blood Sugar Especially when Fasting Plasma Glucose was Controlled

Paris (ots/PRNewswire) -

- Findings Consistent with Known Post-Prandial Effect of Lyxumia

Supporting Combination with Basal Insulin -

Sanofi announced today new GetGoal-L sub-analysis results showing
that reductions in HbA1c with Lyxumia(R) (lixisenatide), when added
to basal insulin, were greatest in patients with type 2 diabetes who
had well-controlled baseline fasting plasma glucose (FPG). These
findings are consistent with the efficacy profile of Lyxumia, which
shows a clinical and statistically significant reduction in HbA1c
across different patient populations.

The results also showed that reductions in body weight with
Lyxumia, when added to basal insulin, were greatest in this group.
The GetGoal-L sub-analysis was shared during an oral presentation at
the 49th Annual Meeting of the European Association for the Study of
Diabetes, in Barcelona, Spain.

"The study showed that Lyxumia is an effective post-prandial
glucose lowering option that improves HbA1c levels when added to
basal insulin," said Professor Josep Vidal, Endocrinology and
Nutrition, University of Barcelona. "We analyzed data from patients
who were not at their target HbA1c level, despite controlled fasting
plasma glucose, and we found that a treatment regimen that targets
post-prandial glucose, as well as fasting plasma glucose, could be an
effective choice for these patients."

As type 2 diabetes progresses over time, patients treated with
basal insulin may no longer maintain their target HbA1c level
(average blood sugar levels over the past 2 to 3 months), despite
typically sustaining good control of FPG with basal insulin. For
these patients, Lyxumia can significantly reduce HbA1c by primarily
reducing post-prandial (after-meal) glucose levels through its
complementary action with basal insulin. Targeting both FPG and
post-prandial glucose could be an effective way to lower HbA1c in
certain patients with type 2 diabetes.

Results of Analysis

This sub-analysis examined 496 patients with type 2 diabetes and
inadequate glucose control. Results showed that the addition of
lixisenatide to basal insulin treatment, with or without metformin
(oral anti-diabetic therapy), reduced overall HbA1c, body weight and
post-breakfast self-monitored post-prandial glucose in all groups.
These effects were greater in patients with relatively
well-controlled baseline FPG levels (below or equal to 6.7 mmol/L;
FPG in people without diabetes is ~5.5 mmol/L[1]) compared to those
with higher baseline FPG levels (between 6.7 and 8.9 mmol/L, and over
8.9 mmol/L, respectively).

The GetGoal-L sub-analysis abstract is entitled: 'Therapeutic
efficacy of lixisenatide added to basal insulin is greater when FPG
is well-controlled' (Vidal J, et al. [Abstract no. oral presentation
6]).

About Lyxumia(R) (lixisenatide)

Lyxumia(R) (lixisenatide) is a glucagon-like peptide-1 receptor
agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes
mellitus. GLP-1 is a naturally-occurring peptide hormone that is
released within minutes after eating a meal. It is known to suppress
glucagon secretion from pancreatic alpha cells and stimulate
glucose-dependent insulin secretion by pancreatic beta cells.

Lyxumia was in-licensed from Zealand Pharma A/S ,
www.zealandpharma.com [http://www.zealandpharma.com ], and is
approved in Europe for the treatment of adults with type 2 diabetes
mellitus to achieve glycemic control in combination with oral
glucose-lowering medicinal products and/or basal insulin when these,
together with diet and exercise, do not provide adequate glycemic
control. Lyxumia is also approved in Mexico, Australia, Japan and
Brazil for the treatment of adults with type 2 diabetes. Sanofi plans
to resubmit the New Drug Application for lixisenatide in the United
States in 2015, after completion of the ELIXA cardiovascular outcomes
study. Lyxumia is the proprietary name approved by the European
Medicines Agency and other health authorities for the GLP-1 RA
lixisenatide.

The Lyxumia pen is the winner of a number of innovative design
awards, including the Red Dot Award, the Good Design Award, and the
iF Product Design Award.

About Sanofi Diabetes

Sanofi strives to help people manage the complex challenge of
diabetes by delivering innovative, integrated and personalized
solutions. Driven by valuable insights that come from listening to
and engaging with people living with diabetes, the Company is forming
partnerships to offer diagnostics, therapies, services, and devices
including blood glucose monitoring systems. Sanofi markets both
injectable and oral medications for people with type 1 or type 2
diabetes.

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, consumer healthcare, emerging markets, animal
health and the new Genzyme. Sanofi is listed in Paris and in New
York .

Reference

1. International Diabetes Federation. Global Guideline for Type 2
Diabetes (2012). Available at:
www.idf.org/sites/default/files/IDF-Guideline-for-Type-2-Diabetes.pdf
[http://www.idf.org/sites/default/files/IDF-Guideline-for-Type-2-Diab
etes.pdf ]. Date accessed: September 2013.

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ots Originaltext: Sanofi Diabetes
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contacts: Media Relations: Jack Cox, Tel.: + (33) 1 53 77 45 02,
jack.cox@sanofi.com; Global Diabetes Communications: Philip McNamara,
Office: + (1) 908 981 5497, Mobile: + (1) 908 210 4047,
philip.mcnamara@sanofi.com; Investor Relations: Sébastien Martel,
Tel.: +
(33) 1 53 77 45 45, ir@sanofi.com; U.S. Diabetes Communications:
Susan
Brooks, Office: + (1) 908 981 6566, Mobile: + (1) 201 572 4994,
susan.brooks@sanofi.com