Sanofi Announces Study Program Evaluating Toujeo® in a Real-Life Setting

PARIS, June 4, 2015 /PRNewswire-USNewswire/ -- Sanofi (EURONEXT: SAN andNYSE: SNY) announced today a program of Phase IV clinical trials to study Toujeo^® (insulin glargine [rDNA origin] injection, 300 units per mL) in 'real-world' conditions. The Real Life Study program in people with type 2 diabetes comprises the ACHIEVE CONTROL, REACH CONTROL and REGAIN CONTROL studies and will compare the clinical effectiveness of Toujeo^® with other basal insulins in a standard care setting, along with additional measures relating to patient experience and health resource utilization.

"There is a need to go beyond drug comparison and move toward investigation of wider diabetes management strategies, where additional factors are considered," commented Riccardo Perfetti, Senior Medical Officer, Vice President Global Medical Affairs, Diabetes Division, Sanofi. "This study program will evaluate how the safety and efficacy findings for Toujeo^® seen in the EDITION studies might now translate into real-life effectiveness in the treatment of adults with type 2 diabetes."

The research program will involve more than 4,500 adults with type 2 diabetes from the U.S. and Europe. It will investigate control of blood sugar levels, incidence of hypoglycemia, persistence with treatment, patient-reported outcomes and health resource usage, with Toujeo^® and other basal insulins as used in the standard care setting.

The ACHIEVE CONTROL study will evaluate the effect of Toujeo^® on achieving individualized glycemic targets without hypoglycemia at any time of day in 3,270 uncontrolled insulin-naïve people in the U.S. with type 2 diabetes. REACH CONTROL will follow 800 insulin-naïve people with type 2 diabetes in Europe, comparing HbA_1c change with Toujeo^® vs. other basal insulins, alongside incidence of hypoglycemia, change in body weight, and measures of persistence with treatment and need for treatment intensification. The REGAIN CONTROL study will compare HbA_1c reduction, incidence of hypoglycemia, change in body weight and persistence with treatment on Toujeo^® vs. other basal insulins in 600 people with type 2 diabetes in Europe, who are currently uncontrolled on basal insulin. In addition to clinical measures, the studies will also collect patient feedback on treatment satisfaction and their experience of hypoglycemia, along with healthcare resource utilization.

The studies are expected to begin randomizing patients in Q2 2015, with initial results expected in 2017. Results from an extended follow-up period are anticipated in 2018.

"While randomized controlled trials establish the efficacy and safety profile in a defined population and address regulatory needs, healthcare professionals, diabetes educators and payers may find real-world evidence provides important value to the management of diabetes," said Luigi Meneghini, MD, MBA, Professor of Internal Medicine at the University of Texas Southwestern Medical Center, Division of Endocrinology, Dallas, Texas, and Principal Investigator of the ACHIEVE CONTROL study. "This program of research is a step forward in meeting this need, evaluating the use of Toujeo^® and other basal insulins in a real life setting."

What is Toujeo^®?

Prescription Toujeo^® is a long-acting insulin used to control blood sugar in adults with diabetes mellitus. 

• Toujeo^® contains 3 times as much insulin in 1 mL as standard insulin (100 Units/mL)
• Toujeo^® is not for use to treat diabetic ketoacidosis
• Toujeo^® should not be used in children

Important Safety Information for Toujeo^® (insulin glargine injection) 300 Units/mL 

Do not take Toujeo^® during episodes of low blood sugar or if you are allergic to insulin or any of the inactive ingredients in Toujeo^®.

Do not share insulin pens even if the needle has been changed. Do NOT reuse needles.

Before starting Toujeo^®, tell your doctor about all your medical conditions, including:

• If you have liver or kidney problems
• If you are pregnant or planning to become pregnant
• If you are breast-feeding or planning to breast-feed

Heart failure can occur if you are taking insulin together with certain medicines called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems.  If you already have heart failure, it may get worse while you take TZDs with Toujeo^®. Tell your doctor if you have any new or worsening symptoms of heart failure, including:

• Shortness of breath
• Swelling of your ankles or feet
• Sudden weight gain

Your treatment with TZDs and Toujeo^® may need to be changed or stopped by your healthcare provider if you have new or worsening heart failure.

Tell your doctor about all the medications you take, including over-the-counter medicines, vitamins, and supplements, including herbal supplements.

Toujeo^® should be taken once a day at the same time each day to lower blood glucose. You must test your blood sugar levels daily while using any insulin, including Toujeo^®. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. You should always verify that you have the correct insulin before each injection. Your dose for Toujeo^® may be different from other insulins you have taken. Any change of insulin should be made cautiously and only under medical supervision.

Do NOT dilute or mix Toujeo^® with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Toujeo^® must only be used if the solution is clear and colorless with no particles visible.

While using Toujeo^®, do not drive or operate heavy machinery until you know how Toujeo^® affects you. You should not drink alcohol or use other medicines that contain alcohol.

The most common side effects of any insulin, including Toujeo^®, is low blood sugar (hypoglycemia), which may be serious and can be life-threatening. Severe hypoglycemia may cause harm to your heart or brain. Symptoms of serious low blood sugar may include shaking, sweating, fast heartbeat, and blurred vision.

Toujeo^® may cause serious side effects that can lead to death, such as severe allergic reactions that affect the whole body. Get medical help right away if you have:

• A rash over your whole body
• Trouble breathing
• Shortness of breath
• Fast heartbeat
• Swelling of your face, tongue, or throat
• Sweating
• Extreme drowsiness, dizziness, or confusion

Toujeo^® may have additional side effects. Other possible side effects may include swelling, weight gain, and low potassium.

Injection site reactions are also possible and may include change in fat tissue at the injection site, skin thickening, redness, swelling, and itching.

Toujeo^® SoloStar^® is a disposable prefilled insulin pen. Please talk to your healthcare provider about proper injection technique and follow instructions in the Instruction Leaflet that accompanies the pen.

Please click here for full Prescribing Information for Toujeo^®:
http://products.sanofi.us/Toujeo/Toujeo.pdf.

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 injectable, inhaled and oral medications for people with type 1 or type 2 diabetes.

About Sanofi
Sanofi, a global 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 Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi 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 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, 2014. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

SOURCE Sanofi