PARIS, Dec. 4, 2017 — Sanofi's Toujeo® 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 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
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.
1. Sanofi, data on file: Insulin glargine 300 U/mL vs insulin degludec in insulin-naïve adults with T2DM: head-to-head trial design and rationale, NCT02738151, November 2017
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