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Switching to Toujeo® in a real-world setting produced a similar number of severe low blood sugar events as insulin degludec

Two large real-world analyses compared adults with type 2 diabetes who were switched to Toujeo (insulin glargine injection 300 Units/mL) to those switched to insulin degludec

Nov 30, 2017

LOS ANGELES, Nov. 30, 2017 /PRNewswire/ -- Adults with type 2 diabetes who switched their basal insulin therapy to Toujeo® or insulin degludec, experienced similar numbers of low blood sugar (hypoglycemia) events, according to the findings of two comparative real-world studies. Patients also experienced similar reduction of average blood sugar (HbA1c) with the different insulin treatments.

The results were presented today at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease in Los Angeles, CA, U.S.1,2

The two studies, known as LIGHTNING and DELIVER D, are part of the comparative study program for Toujeo versus insulin degludec. Both studies were retrospective observational analyses based on two different large U.S. databases of electronic medical records and claims using a statistical technique (propensity score matching) for making the treatment groups comparable. This minimizes observed sources of bias typically found in simple observational studies.

"With the patient matching approach used in the two studies, physicians and payers will have access to additional findings to evaluate Toujeo in a real-life setting," said Riccardo Perfetti, Head of Global Diabetes Medical Team, ‎Sanofi. "Data evaluating the risk of severe low blood sugar (hypoglycemia) can also help educate providers on treatment options."

LIGHTNING: The largest real-world comparative study in diabetes

The LIGHTNING retrospective observational study1 is the largest real-world comparative study in diabetes. It used statistical techniques, such as propensity score matching and predictive modeling, to evaluate electronic medical records for 130,155 adult patients who were treated with long-acting insulin treatment in the U.S. Optum-Humedica database.

After Propensity Score Matching (PSM), 8,456 adult patients with type 2 diabetes who switched from using insulin glargine 100 Units/mL to Toujeo or insulin degludec were compared in a routine care setting. The majority of patient baseline characteristics were similar across basal insulin treatment groups. Analysis showed that the risk of severe hypoglycemia related to an inpatient or emergency department visit was comparable in both groups of patients (p=0.37) with no differences in HbA1c.

DELIVER D: Further results from the DELIVER comparative program

In the DELIVER D retrospective observational study2, it used electronic medical records (EMR) for 22,492 adult patients who were treated with long-acting insulin treatment in the U.S. Predictive Health Intelligence Environment (PHIE) database. After PSM, 1,620 adult patients with type 2 diabetes who switched from using insulin glargine 100 Units/mL to Toujeo or insulin degludec were compared in a routine care setting. The majority of patient baseline characteristics were similar across basal insulin treatment groups.

During the 6-month follow-up period, patients in both groups showed comparable numbers of patients experiencing any low blood sugar (hypoglycemia) events (p=0.45). The number of patients experiencing low blood sugar events associated with hospital or emergency department visit was also similar in both groups (p=0.80). Reduction in average blood sugar levels (HbA1c) were comparable between the two groups (p=0.97). Patients on Toujeo and those on insulin degludec were equally likely to attain HbA1c < 7.0% (12.9% vs 15.9%, respectively; P = 0.24) and HbA1c < 8.0% (44.2% vs 44.6%, respectively; P = 0.92) during 3-6 months' follow-up.

While the findings from both studies represent actual patterns of treatment and outcomes outside the confines of clinical trials, electronic medical records are not completed for research purposes and vary in completeness. As a result limitations of these analyses include potential incomplete dosage information, under-reporting of hypoglycemia, and lack of information about reasons for switching treatment. In addition, the PSM process results in a smaller overall dataset compared with the available patient data pool.

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

References

  1. Zhou LF et al, "Hypoglycemia risk associated with basal insulin use in type 2 diabetes (T2DM): The Lightning study", World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease in Los Angeles, CA, U.S., November 30December 2.
  2. Blonde L et al, "Real-world evidence demonstrates comparable clinical outcomes of switching from insulin glargine 100 U/mL (Gla-100) to insulin glargine 300 U/mL (Gla-300) vs insulin degludec (IDeg) in patients with type 2 diabetes (T2D)", World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease in Los Angeles, CA, U.S., November 30December 2.

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

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.

 

SOURCE Sanofi

For further information: Media Relations Contact, Ashleigh Koss, Tel.: (908) 981-8745, ashleigh.koss@sanofi.com, or Investor Relations Contact, George Grofik, Tel.: +33 (0)1 53 77 45 45, ir@sanofi.com, or US Diabetes and Cardiovascular Communications, Susan Brooks, Tel.: (908) 981-6566, susan.brooks@sanofi.com

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