PARIS, June 11, 2016 /PRNewswire/ -- Sanofi announced today the release of the new real world data assessing the use of Toujeo® (insulin glargine injection 300 Units/mL). The U.S. Predictive Health Intelligence Environment (PHIE) database, containing a substantial amount of patient level information, was analyzed to assess Toujeo in this real life setting. The study examined electronic health records to assess the change in HbA1c (average blood sugar levels) and occurrence of hypoglycemia in patients up to 6 months after switching to Toujeo from another basal insulin. The results of the study were presented on June 11 at the American Diabetes Association 76th Scientific Sessions in New Orleans, LA, U.S.A.
"In the first evaluation of Toujeo in the real-world care setting, it is encouraging for the treatment of adults with type 2 diabetes to see the successful switching to Toujeo from another basal insulin," said Riccardo Perfetti, Head of Global Diabetes Medical Team, Sanofi.
"This study adds to the growing evidence in the knowledge of the use of Toujeo, in patients with Type 2 diabetes," said Professor Robert Ritzel, a Toujeo clinical trials program investigator and Head Physician of the Clinic for Endocrinology, Diabetes and Addiction Medicine, Schwabing Hospital, Munich, Germany. "While adequate and well-controlled clinical trials are vital for regulatory requirements and guidance of clinical decision making, further evidence in a real-world care setting is particularly relevant for health-care professionals, payers and other organizations when assessing safety and efficacy in larger patient populations and cost-effectiveness."
Sanofi is committed to evaluate Toujeo in the real life settings and is conducting three large studies called ACHIEVE, REACH and REGAIN CONTROL in type 2 diabetes patients starting basal insulin treatment or switching from another basal insulin. These studies involve more than 4,500 patients across the U.S. and Europe. Initial results of the Real-Life Study Program are anticipated in 2017.
Results of Analysis
Adults with type 2 diabetes who had used other basal insulins within the 6 months prior to Toujeo initiation (one or more prescription order of Toujeo between March 2015 and December 2015) were identified. The PHIE records of those identified (N=881) were assessed for HbA1c and incidence of confirmed (≤70 mg/dL) or severe hypoglycemia up to 6 months prior to and up to 6 months after initiation.
Among the subpopulation of patients (n=267) with HbA1c measured at baseline and during follow-up (0-6 months), mean HbA1c was 8.97% at baseline and 8.33% at follow-up. For the subpopulation of patients (n=449) with occurrence of hypoglycemia measured at baseline and during follow-up (0-3 months), this was 6.0% at baseline and 5.1% at follow-up.
The study abstract is titled: Real-World Assessment of Patient Characteristics and Clinical Outcomes of Early Users of the New Insulin Glargine 300U/mL (Ye, F et al. Poster presentation 943-P, American Diabetes Association 76th Scientific Sessions, New Orleans, LA, U.S. Saturday, June 11, 2016).
About ACHIEVE, REACH and REGAIN CONTROL
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-naive people in the U.S. with type 2 diabetes.
The REACH CONTROL will follow 800 insulin-naïve people with type 2 diabetes in Europe, comparing HbA1c 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 HbA1c 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.
Toujeo is a once-daily basal insulin based on a broadly-used molecule (insulin glargine). Toujeo has been approved by the U.S. Food and Drug Administration (FDA), the European Commission, Health Canada, the Therapeutic Goods Administration in Australia, and the MHLW in Japan (where its approved brand name is Lantus® XR), and is under review by other regulatory authorities around the world.
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® during episodes of 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 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 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 of heart failure, including:
- Shortness of breath
- Swelling of your ankles or feet
- Sudden weight gain
Tell your doctor about all the medications you take, including OTC medicines, vitamins, and supplements, including 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 make changes to your dose or type of insulin without talking to your doctor. Verify 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. 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. 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
- Extreme drowsiness, dizziness, or confusion
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.
Please see full Prescribing Information for Toujeo® on Toujeo.com or click here http://products.sanofi.us/Toujeo/Toujeo.pdf
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. 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 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, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, 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, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.