Sanofi to present new clinical data at the American Diabetes Association 73rd Scientific Sessions

Sanofi (EURONEXT : SAN and NYSE : SNY) announced today that clinical data highlighting the company’s ongoing commitment to advancing diabetes care will be presented at the American Diabetes Association (ADA) 73rd Scientific Sessions in Chicago, USA (June 21−25, 2013). In total, more than 60 abstracts representing new data sets on Sanofi diabetes drugs, investigational drugs or medical devices are part of the official scientific program.

“The American Diabetes Association annual meeting provides an important opportunity for Sanofi to share significant data with the medical community and to demonstrate our focus on advancing scientific thinking in the field of diabetes treatment,” said Pierre Chancel, Senior Vice President, Global Diabetes at Sanofi. “The data being presented further support the company’s leadership in integrated diabetes care and delivering personalized solutions that directly target the needs of people living with this disease.”

Among the study findings being presented in poster and oral scientific sessions are the following (abstracts have been posted on the ADA website):

Investigational new insulin U300
The EDITION I study compared the efficacy and safety of investigational new insulin U300 vs. Lantus® (insulin glargine) in people with type 2 diabetes using basal plus mealtime insulin. The EDITION I study is part of a larger Phase III clinical program.

“New insulin glargine formulation: glucose control and hypoglycemia in people with type 2 diabetes using basal and mealtime insulin (EDITION I)”
Embargo lifts: Saturday, June 22, 10 am CST
Presenter: M. Riddle, Oregon Health and Science University, Portland, USA
Location: Poster Hall

The pharmacodynamic and pharmacokinetic properties of the investigational new insulin U300 were examined in a double-blind, randomized study in patients with type 1 diabetes:

“Euglycemic clamp profile of new insulin glargine U300 formulation in patients with type 1 diabetes (T1DM) is different from glargine U100”
Embargo lifts: Saturday, June 22, 10 am CST
Presenter: R. Dahmen, Sanofi, Frankfurt am Main, Germany
Location: Poster Hall (also available as an ePoster on the ADA website after 10 am, June 22)

“New insulin glargine U300 formulation evens and prolongs steady state PK and PD profiles during euglycemic clamp in patients with type 1 diabetes (T1DM)”
Embargo lifts: Saturday, June 22, 1:45 pm CST
Presenter: T. Jax, Profil, Neuss, Germany
Location: W-375A

Lyxumia® (lixisenatide)*
Lyxumia®, the first once-daily prandial GLP-1 receptor agonist, is approved in the European Union 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® data include two analyses investigating its post-prandial mechanism of action:

“Once-daily lixisenatide as add-on to basal insulin ± OADs in patients with type 2 diabetes selectively reduces postprandial hyperglycemic daytime exposure”
Embargo lifts: Saturday, June 22, 10 am CST
Presenter: M. Riddle, Oregon Health and Science University, Portland, USA
Location: Poster Hall (also available as an ePoster on the ADA website after 10 am, June 22)

“Efficacy of lixisenatide in the GetGoal clinical trial program: pooled analysis of postprandial metabolic outcomes”
B. Ahrén, Lund University, Sweden. Abstract publication only.

Further data include analyses of the effects of Lyxumia® in combination with basal insulin on HbA1c, weight gain and symptomatic hypoglycemia in patients with type 2 diabetes:

“Expanding the basal-plus regimen: basal insulin + lixisenatide is more likely to achieve the composite outcome of HbA1c <7%, no documented symptomatic hypoglycemia and no weight gain compared with basal + prandial insulin”
Embargo lifts: Saturday, June 22, 10 am CST
Presenter: J. Rosenstock, Dallas Diabetes & Endocrine Center, Texas, USA
Location: Poster Hall (also available as an ePoster on the ADA website after 10 am, June 22)

“Meta-analysis of randomized controlled trials of lixisenatide as add-on to basal insulin in patients with type 2 diabetes mellitus”
Embargo lifts: Saturday, June 22, 10 am CST
Presenter: B. Charbonnel, University of Nantes, France
Location: Poster Hall (also available as an ePoster on the ADA website after 10 am, June 22)

ORIGIN (Outcome Reduction with Initial Glargine INtervention)1
ORIGIN is a unique, seven-year landmark cardiovascular (CV) outcomes trial, evaluating Lantus® vs. standard care in over 12,500 individuals who are at high CV risk with pre-diabetes or early type 2 diabetes mellitus. Spanning 40 countries worldwide, it is the world’s longest and largest randomized clinical trial of its type in this population, and the first to formally evaluate the effects of insulin on CV outcomes.

Results from a new sub-analysis of ORIGIN will be presented:

“Cancer outcomes in patients with dysglycemia on basal insulin: results of the ORIGIN trial”
Embargo lifts: Monday, June 24, 8 am CST
Presenter: LJ. Bordeleau, McMaster University, Ontario, Canada
Location: S-103B

ATLAS (Asian Treat to Target Lantus® Study)
The ATLAS study compared the effectiveness of a patient-led vs. physician-led initiation of Lantus® in 552 patients with type 2 diabetes in Asia and Russia. Due to the specific challenges faced by people living with diabetes in Asia, this study investigated whether self-adjustment of insulin in this population is similarly effective at lowering blood glucose levels as it is in Western diabetes patients.

Data from ATLAS includes:

“Asian Treat to Target Lantus Study (ATLAS): a 24 week randomized, multinational study”
Embargo lifts: Saturday, June 22, 10 am CST
Presenter: S. Garg, University of Colorado Health Sciences Center, Denver, Colorado, USA
Location: Poster Hall

“Evaluating the patient experience in the Asian Treat to Target Lantus Study (ATLAS): a 24-week randomized, multinational study”
Embargo lifts: Saturday, June 22, 10 am CST
Presenter: N. Freemantle, University College London, UK
Location: Poster Hall

BGStar®
Now available in 14 countries across four continents, our intuitive blood glucose monitoring (BGM) devices BGStar® and iBGStar® form a key part of our comprehensive patient-centric portfolio and are at the heart of our integrated approach to diabetes.

Key BGStar® data show that the performance of our self-monitoring BGM device achieves similar system accuracy as point of care testing systems for professional use:

“Evaluating system accuracy of blood glucose monitoring systems for point of care testing”
Embargo lifts: Saturday, June 22, 10 am CST
Presenter: G. Freckmann, Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Germany
Location: Poster Hall (also available as an ePoster on the ADA website after 10 am, June 22)

Sanofi will host a conference call for the financial community during the upcoming ADA 73rd Scientific Sessions. The call will include results from the ongoing EDITION Phase III program for the company’s investigational new insulin U300 as well as a status update on the fixed-ratio combination of insulin glargine and lixisenatide.

The conference call will take place on Monday June 24, 2013, at 7 am CST (2 pm CET). Dial-in numbers and the audio webcast link will be accessible via www.sanofi.com