Sanofi's ToujeoŽ met main objective in head-to-head study versus insulin degludec

Monday, December 4, 2017 General News
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First head-to-head randomized clinical trial comparing the efficacy and safety of Toujeo (insulin glargine 300 Units/mL) versus insulin degludec

PARIS, Dec. 4, 2017 /PRNewswire-USNewswire/ -- Sanofi's ToujeoŽ met the primary study objective in the first large head-to-head

clinical trial1, called BRIGHT study, comparing Toujeo with insulin degludec. Sanofi plans to provide full results in 2018.

The primary objective was to determine if the effect of Toujeo on blood sugar levels (HbA1c) was similar to insulin degludec. Secondary objectives included the percentage of patients experiencing adverse events, the total number of participants with low blood sugar events during the study and the rate at which low blood sugar events occurred. The study specifically followed 929 adults whose type 2 diabetes was previously uncontrolled on non-insulin medication.

"The most recently introduced long-acting insulins have already demonstrated significant blood glucose lowering benefit to adult patients with diabetes. From the perspective of physicians and patients, hypoglycemia remains a major limiting factor in effective blood sugar management in diabetes. We believe that these first comparative clinical data assessing similarity and difference not only in efficacy, but also in the important safety aspect, such as low blood sugar events, can support physicians in their treatment decisions," said Riccardo Perfetti, Head of Global Diabetes Medical Team, ?Sanofi. "We look forward to release of the full results of the study."

About the head-to-head study

The BRIGHT study included adults with type 2 diabetes who had failed to control their HbA1c with oral antihyperglycemic drugs (OADs) with or without a glucagon-like peptide-1 (GLP-1) receptor agonist.

Additional secondary endpoints included the percentage of participants requiring rescue therapy, safety, and patient-reported outcomes measured using the Diabetes Treatment Satisfaction Questionnaire (DTSQ, status version and change version) and the Hypoglycemic Attitudes and Behavior Scale.

What is ToujeoŽ (insulin glargine injection) 300 Units/mL?

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

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

Important Safety Information for ToujeoŽ (insulin glargine injection) 300 Units/mL

Do not take ToujeoŽ if you have low blood sugar or if you are allergic to insulin or any of the ingredients in ToujeoŽ.

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

Before starting ToujeoŽ, 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 or if you are breastfeeding or planning to breastfeed.

Heart failure can occur if you are taking insulin together with pills called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with ToujeoŽ. Your treatment with TZDs and ToujeoŽ may need to be changed or stopped by your doctor if you have new or worsening heart failure. Tell your doctor if you have any new or worsening symptoms including:

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

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

Toujeo should be taken at the same time once a day. Test your blood sugar levels daily while using any insulin, including ToujeoŽ. Do not change your dose or type of insulin without talking to your doctor. Verify you have the correct insulin before each injection. Do NOT use a syringe to remove ToujeoŽ from your SoloStarŽ pen. Your dose for ToujeoŽ 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 ToujeoŽ with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Use ToujeoŽ only if the solution is clear and colorless with no particles visible.

While using ToujeoŽ, do not drive or operate heavy machinery until you know how ToujeoŽ affects you. Don't drink alcohol or use other medicines that contain alcohol.

The most common side effect of any insulin, including ToujeoŽ, 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.

ToujeoŽ may cause severe allergic reactions that can lead to death. Get medical help right away if you have:

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

ToujeoŽ may have additional side effects including swelling, weight gain, low potassium, and injection site reactions which may include change in fat tissue, skin thickening, redness, swelling, and itching.

ToujeoŽ SoloStarŽ is a disposable prefilled insulin pen. Talk to your doctor about proper injection technique and follow instructions in the Instruction Leaflet that comes with the pen.

Please see full Prescribing Information for ToujeoŽ on Toujeo.com or click here: http://products.sanofi.us/Toujeo/Toujeo.pdf. 

References 1.      Sanofi, data on file: Insulin glargine 300 U/mL vs insulin degludec in insulin-naīve adults with T2DM: head-to-head trial design and rationale, NCT02738151, November 2017

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

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 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, Sanofi's ability to benefit from external growth opportunities and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the  ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives 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, 2016. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

View original content:http://www.prnewswire.com/news-releases/sanofis-toujeo-met-main-objective-in-head-to-head-study-versus-insulin-degludec-300565795.html

SOURCE Sanofi



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