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.
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:
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:
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.
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