Toujeo® reduced risk of severe low blood sugar compared to insulin glargine 100 Units/mL and insulin detemir

VIENNA – February 14, 2018 – With the continued evolution in diabetes care and a growing understanding of today’s insulin options, Sanofi is pleased to share new real-world evidence results which showed that Toujeo® (insulin glargine 300 Units/mL) significantly reduced the risk of severe low blood sugar (hypoglycemia) events compared to the long-acting insulins, insulin glargine 100 Units/mL (Lantus) and insulin detemir. These data are being presented at the 11th Annual Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Vienna, Austria.

New findings from LIGHTNING, the largest and most recent real-world comparative study involving more than 10,000 patients treated with long-acting insulins, found that Toujeo reduced the risk of severe low blood sugar events, defined as an event-related inpatient or emergency room visit for people with type 2 diabetes, by more than 60% compared to insulin glargine 100 Units/mL and insulin detemir. The data also showed that the risk of severe low blood sugar events were comparable between Toujeo and insulin degludec. The reduction of blood sugar levels were not compromised in any of the treatment arms. Further analyses are planned to correlate the findings with clinical and economic outcomes.

About LIGHTNING Study

The LIGHTNING study evaluated electronic medical records of 130,155 adult patients in the U.S. Optum-Humedica database who were treated with long-acting insulin. Using innovative statistical techniques, the study identified 10,458 adults with type 2 diabetes, with a majority of similar demographics and clinical characteristics, who switched from using any long-acting insulin to Toujeo, insulin glargine 100 Units/mL or insulin detemir.

“Sanofi is committed to conducting ongoing research of our medicines to help healthcare professionals better understand not only their efficacy, but also important safety information such as the risk of hypoglycemia when compared to other treatment options,” said Michelle Carnahan, North America Diabetes and Cardiovascular Head, Sanofi. “These data add to a consistent body of evidence comparing Toujeo with long-acting insulins and strengthens our belief in using machine learning and big data to push the boundaries of real-world studies to help inform healthcare professionals’ and payers’ treatment decisions.”

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

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® if you have low blood sugar or if you are allergic to insulin or any of the ingredients in Toujeo®.

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

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 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 Toujeo®. Your treatment with TZDs and Toujeo® 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 Toujeo®. 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 Toujeo® from your SoloStar® pen. 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. Use Toujeo® only 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. Don’t drink alcohol or use other medicines that contain alcohol.

The most common side effect 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 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

Toujeo® 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.

Toujeo® SoloStar® 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 Toujeo® on Toujeo.com or click here: http://products.sanofi.us/Toujeo/Toujeo.pdf

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 regarding the marketing and other potential of the product, or regarding potential future revenues from the product. 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, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the absence of guarantee that the product will be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic conditions, as well as those risks 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.

US Media Relations:
Ashleigh Koss, Tel. : +1 (908) 981-8745, Mobile: +1 (908) 205-2572, Ashleigh.Koss@sanofi.com;

Investor Relations:
George Grofik, Tel. : +33 (0)1 53 77 45 45, ir@sanofi.com