In Senior Adults Treated with Basal Insulin, Switching to Sanofi's Toujeo® Halved Hypoglycemia Risk

SAN DIEGO, June 10, 2017 /PRNewswire/ -- Sanofi announced today new evidence from a real-world observational study demonstrating significantly less risk of documented hypoglycemia with similar blood sugar control after switching to Toujeo^® (insulin glargine 300 Units/mL) compared to switching to another basal insulin including Lantus^® (insulin glargine 100 Units/mL), Levemir^® (insulin detemir) and Tresiba^® (insulin degludec), in an at-risk population of senior adults (aged ≥65 years) with type 2 diabetes. The results of the DELIVER 3 retrospective observational study comparing two cohorts were presented at the American Diabetes Association (ADA) 77^th Scientific Sessions Annual Meeting in San Diego, CA, U.S.

In the DELIVER 3 study,¹ patients switching to Toujeo were 57 percent less likely to experience hypoglycemia at 6-month follow-up (Odds Ratio: 0.432, 95% CI: 0.307 to 0.607, p<0.0001) than those who switched to another basal insulin, with similar glycemic control (least squares mean difference -0.09%, p=0.24).

"Older patients with type 2 diabetes are disproportionately impacted by hypoglycemia and its consequences," said Jeremy Pettus, Assistant Professor, Division of Endocrinology, University of California, San Diego, U.S. "Observational real-world data such as DELIVER 3 can contribute to clinical decision-making, helping physicians to better advise their patients in this important at-risk population."

These findings are broadly consistent with Toujeo evidence from DELIVER 2, a retrospective observational study that included two matched cohorts of 1,827 (n=3,654) adults with type 2 diabetes using basal insulin who switched to either Toujeo or another basal insulin. DELIVER 2 showed 33 percent fewer hypoglycemic events after 6 months in a broader population of adults with type 2 diabetes, which contributed to an estimate of all-cause healthcare cost savings of up to approximately $2,000 per patient per year.²

"The findings from DELIVER 2 and 3 demonstrate the real-life clinical benefit of Toujeo vs other basal insulins, and how this translates into overall cost savings. Complementing these observational studies in a real-life setting, Sanofi is also conducting a unique program of three randomized, prospective, open-label real-life clinical studies with Toujeo," said Riccardo Perfetti, Head of Global Diabetes Medical Team, ‎Sanofi. "The methodology of these studies could provide a better understanding of the comparative benefit of Toujeo vs. other basal insulins, and the findings might be relevant to future clinical practice and evaluation of overall cost of care."

These randomized, prospective real-life clinical studies, called ACHIEVE CONTROL, REACH CONTROL and REGAIN CONTROL, involve more than 4,500 people with type 2 diabetes across the U.S. and Europe who are starting basal insulin treatment or switching from another basal insulin. In addition to clinical measures, the studies will also collect patient feedback on treatment satisfaction and their experience of hypoglycemia, along with impact on healthcare resource utilization. Initial results are anticipated later in 2017.

Summary of DELIVER program
The DELIVER program comprises several non-interventional retrospective analyses using data from the Predictive Health Intelligence Environment (PHIE) database of U.S. real-world electronic medical records, currently representing 37 integrated health delivery networks. Hypoglycemia was identified in the dataset by diagnosis code (ICD9/10 codes) or plasma glucose (≤70mg/dL by laboratory test).

These findings represent actual prescribing patterns and clinical outcomes outside the confines of a clinical trial, which might include drug use outside U.S. Food and Drug Administration (FDA)-approved prescribing information. As a result, reporting of hypoglycemia at baseline and in both treatment arms were not based on self-monitored blood glucose, which could result in less severe events not being reported by patients. The limitations in the DELIVER studies are similar to those generally observed in such studies.

The DELIVER 3¹ retrospective observational study included 1,610 people with type 2 diabetes aged ≥65 years on basal insulin who switched to either Toujeo or another basal insulin (insulin glargine 100 Units/mL, insulin detemir or insulin degludec). Patients switching to Toujeo were 57 percent less likely to experience hypoglycemia at 6-month follow-up (Odds Ratio: 0.432, 95% CI: 0.307 to 0.607, p<0.0001) than those who switched to another basal insulin. Switching to Toujeo or another basal insulin resulted in comparable changes in HbA_1c (least squares mean difference -0.09%, p=0.24).

The DELIVER 2² retrospective observational study included two matched cohorts of 1,827 (n=3,654) adults with type 2 diabetes using basal insulin who switched to either Toujeo or another basal insulin (insulin glargine 100 Units/mL, insulin detemir or insulin degludec). After 6 months, patients who switched to Toujeo experienced 25 percent fewer hypoglycemic events than those who switched to other basal insulins (mean hypoglycemia event rate per patient per year: 0.667 vs. 0.902; difference: -0.225 events per patient per year; p<0.01) with comparable blood glucose control. Patients switching to Toujeo experienced significantly fewer all-cause hospital in-patient days (least squares mean difference: −0.714, 95% CI: −1.285 to −0.143, p=0.01), emergency department visits (least squares mean difference: −0.177 events/PPPY, 95% CI: −0.319 to −0.036, p=0.01) and outpatient events (least squares mean difference: −0.985 events/PPPY, 95% CI: −1.610 to −0.359, p<0.01) during 6 months of follow-up compared to patients who switch to another basal insulin, translating to savings of $2,071 per patient per year.

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 Diabetes & Cardiovascular
Diabetes and cardiovascular disease affect millions of people worldwide, with many managing the complex challenges of both. Building on our portfolio evolution, heritage and expertise, Sanofi has a focused business unit dedicated to delivering innovative, value-based medicines and integrated solutions in these therapeutic areas. We are committed to a collaborative approach that involves strategic alliances with professional and patient associations, research institutions and leaders in healthcare and other industries, with the goal of advancing scientific knowledge, driving the convergence of science and technology, helping to improve outcomes and inspiring an evolution in care.

About Sanofi
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 Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

References

1. Zhou FL et al, Older Adults with Type 2 Diabetes (T2D) Experience Less Hypoglycemia When Switching to Insulin Glargine 300 U/mL (Gla-300) vs Other Basal Insulins (DELIVER 3 Study), Poster 986-P, American Diabetes Association (ADA) 77th Scientific Sessions, San Diego, CA, U.S., June 10, 2017.
2. Zhou FL et al, Lower Risk of Hypoglycemia and Less Health Care Utilization in Basal Insulin-Treated Patients with Type 2 Diabetes (T2D) After Switching to Insulin Glargine 300 U/mL (Gla-300) vs Other Basal Insulins in Real-World Clinical Settings, Poster NR 1151, American Association of Clinical Endocrinologists (AACE) 26^th Annual Scientific & Clinical Congress, Austin, TX, U.S., May 3–7 2017.

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 clinical development of and potential marketing approvals for the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans", "will be" 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 of the product, 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 the product as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of the product, the absence of guarantee that the product if approved will be commercially successful, risks associated with intellectual property, future litigation, the future approval and commercial success of therapeutic alternatives, 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

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