Sanofi and T1D Exchange to Launch Worldwide Study to Investigate Factors for Optimal Care for Young People with Diabetes
PARIS and BOSTON, Nov. 14, 2012 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and T1D Exchange, a non-profit organization focused on type 1 diabetes, announced today on World Diabetes Day that they will collaborate on the TEENs registry study. The aim of the study is to provide the type 1 diabetes community with a better understanding of how children, adolescents and young adults are currently living with type 1 diabetes, and to deliver recommendations for better disease management and patients outcomes.
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TEENs, also known as the "Glycemic control and quality of life in children, adolescents, and young adults with type 1 diabetes mellitus described in a worldwide, cross-sectional study in 2012," is a multinational, observational, cross-sectional study that will evaluate the percentage of type 1 diabetes patients between the ages of 8 and 25 with controlled glycemia, as measured by hemoglobin A1c (HbA1c). Secondary outcomes will include measurements of quality of life and emotional status, the relationship between glycemic control and quality of life, and the impact of factors such as medical care on these two measurements.
"To better understand how to treat young people with type 1 diabetes, we need to know how exactly they are living with the disease. Our goal with the TEENs study is to examine how clinical factors such as glycemic control impact the quality of life of this particularly vulnerable group of young people with diabetes ," said Riccardo Perfetti, MD, Vice President Medical Affairs, Global Diabetes, Sanofi. "TEENs is another example of Sanofi's ongoing commitment to further develop the understanding of optimal type 1 diabetes care."
The TEENs study will enroll more than 7,000 people with type 1 diabetes in 20 countries, with a sample representative of the typical medical care in the respective country. In the US, Sanofi works in partnership with T1D Exchange for the recruitment of the young study participants and for implementation of this study. Worldwide, Sanofi partners with various clinic centers, hospitals, and healthcare professionals.
"We are excited to support Sanofi and the TEENs study with T1D Exchange's patient registry and extensive clinic network in the US. We are also honored to be designated by Sanofi as a clinical trial Center of Excellence," said Dana Ball, CEO and Cofounder of the T1D Exchange. "This collaboration demonstrates the unique efficiencies and capabilities that partnerships with foundation-driven clinical exchanges can create."
Data will be collected from healthcare professionals, parents or guardians, and patients. Anticipated outcomes include: identification of predictive factors for glucose control and acute complications of type 1 diabetes, better understanding of unmet needs of young people with type 1 diabetes in different age groups, documentation of insulin regimens in young people with type 1 diabetes, and description of the patient journey from pediatric to adult care services.
Results from the TEENs study will be presented at scientific congresses in 2013 and in 2014.
About Diabetes
Diabetes is a chronic disease that occurs as type 1 diabetes, which
is an autoimmune disease characterized by the lack of insulin (the
hormone that regulates blood glucose concentrations) production by
the pancreas, and type 2, a metabolic disorder in which there are
two main biological defects: a deficient production of insulin and
reduced ability of the body to respond to the insulin being
produced. Type 1 and type 2 diabetes are characterized by an
increase in blood glucose concentrations (hyperglycemia). Over
time, uncontrolled hyperglycemia leads to the macrovascular and
microvascular complications of diabetes. Macrovascular
complications, which affect the large blood vessels, include heart
attack, stroke and peripheral vascular disease. Microvascular
complications affect the small blood vessels of the eyes
(retinopathy), kidney (nephropathy) and nerves (neuropathy). More
than 18 million people worldwide are living with type 1 diabetes.
And, the incidence of type 2 diabetes is growing at an alarming
rate, with nearly 348 million people worldwide living with the
condition today.
About T1D Exchange
T1D Exchange is a non-profit organization with the mission to
improve outcomes of people touched by type 1 diabetes by
accelerating the discovery of new approaches to research and
development. It connects the disparate stakeholders in the type 1
diabetes community by combining the critical components of
traditional clinical research with the expanding fields of health
information technology and social networking.
T1D Exchange evolved as a solution to mitigate barriers and inefficiencies for type 1 diabetes research and development. It is a personalized exploration platform anchored in health informatics: T1D Exchange consists of Glu, an interactive website with mobile capabilities for patients and caregivers; a network of 69 clinics across the United States; and a biorepository comprising clinically annotated patient biological samples. T1D Exchange was founded in 2011 through a grant from The Leona M. and Harry B. Helmsley Charitable Trust. More information is available at www.t1dexchange.org.
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 innovative blood glucose monitoring systems.
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 receptor agonist being studied
as a single agent, in combination with basal insulin, and/or in
combination with oral anti-diabetic 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, consumer healthcare, emerging markets, animal
health and the new Genzyme. Sanofi is listed in Paris (EURONEXT:
SAN) and in New York (NYSE: SNY).
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
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"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 labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the absence of guarantee that the
product 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,
trends in exchange rates and prevailing interest rates, the impact
of cost containment policies and subsequent changes thereto, the
average number of shares outstanding 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, 2011. Other
than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
Contacts:
Sanofi
T1D Exchange
Corporate Media Relations
Ellen Giller
Marisol Peron
Tel: + 1 (617) 892-6132
Tel: +33 1 53 77 45 02
E-mail: egiller@t1dexchange.org
Mobile: +33 6 08 18 94 78
E-mail: mr@sanofi.com
Global Diabetes Division Communications
Tilmann Kiessling
Mobile: +49 172 61 59 291
E-mail: TilmannKiessling@sanofi.com
US Diabetes Communications
Susan Brooks
Tel: +1 (908) 981-6566
Mobile: +1 (201) 572-4994
E-mail: Susan.Brooks@sanofi.com
SOURCE Sanofi
Web Site: http://www.t1dexchange.org
Posted: November 2012
