Daily Blood Glucose Measures in Phase 3 Clinical Trials Demonstrated Better Stability with Sanofi's Toujeo® vs. Insulin Glargine 100 Units/mL

LISBON, Portugal, Sept. 13, 2017 /PRNewswire-USNewswire/ -- In a new analysis¹ of late stage clinical trials,^2-4 adults with type 2 diabetes treated with Sanofi's Toujeo^® (insulin glargine 300 Units/mL, Gla-300) achieved better blood glucose stability than those on insulin glargine 100 Units/mL (Lantus^®, Gla-100). These improvements in blood glucose stability were statistically significant in EDITION 2 and SENIOR, and for night-time measurements in EDITION 3. The analysis was presented at the European Association for the Study of Diabetes (EASD) 53^rd annual meeting in Lisbon, Portugal.

"The analysis used an innovative risk-based measure, the Low Blood Glucose Index (LBGI), which was calculated using blood glucose level data collected during the studies. This metric was confirmed as a powerful predictor of documented symptomatic (< 3 mmol/L [54 mg/dL]) and severe hypoglycemia among the Glycemic Variability measures tested.¹ Its clinical relevance lies in the fact that from simple self-measured blood glucose values, it can identify patients who are at high risk of hypoglycemia," said Boris Kovatchev, Director, University of Virginia Center for Diabetes Technology and Professor at the University of Virginia School of Medicine. "Patients treated with Gla-300 achieved lower blood glucose variability and risk of documented symptomatic and severe hypoglycemia, confirmed by LBGI values, consistently in all three clinical trials. The hypoglycemia risk difference in favor of Toujeo was most evident during the night."

"These data add to the consistent body of evidence around Gla-300, which includes a continuous glucose monitoring (CGM) study,^3,5 and comparative observational studies like the DELIVER program,^6,7 in patients with type 2 diabetes," said Riccardo Perfetti, Vice-President Global Medical Affairs, DCV Medical Affairs, Sanofi.

About this Low Blood Glucose Index analysis
This study re-analyzed patient-level data from the EDITION 2 and EDITION 3 clinical trials in adults with type 2 diabetes,^2,3 and the recently-completed SENIOR study in elderly patients with type 2 diabetes.⁴ Participants collected Self-Measured Blood Glucose data throughout the study (8 times per day in the EDITION studies, and 5 times per day in SENIOR). This was analyzed to calculate glucose variability using a variety of measure, including Low Blood Glucose Index (LBGI), a risk-based metric of glucose variability in the hypoglycemic range, which was assessed alongside documented symptomatic (< 3.3 mmol/L [54 mg/dL]) hypoglycemia reported during the studies.

Table - Low Blood Glucose Index values in EDITION 2, EDITION 3 and SENIOR studies

The analysis demonstrated reductions in glucose variability and hypoglycemia risk with Gla-300 compared with Gla-100; these were statistically significant in EDITION 2 and SENIOR, and for night-time measurements in EDITION 3. These risk differences were most prominent overnight and were consistent across the titration and maintenance periods for both EDITION 2 and EDITION 3 studies.

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).

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 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.

References

1. B. Kovatchev et al, Glucose Variability and Risk for Hypoglycemia on Glargine 300 U/mL vs Glargine 100 U/mL, evaluated by the Low BG Index in Randomized Phase Ill Clinical Trials, A-17-1332-EASD, Presentation #78, September 2017
2. Yki-Järvinen H, et al. Diabetes Obes Metab. 2015;17(12):1142-9, DOI: 10.1111/dom.12532.
3. Bolli GB, et al. Diabetes & Metabolism (2017) in press.
4. Ritzel R et al. Poster #469 at 21st International Association of Gerontology and Geriatrics (IAGG) World Congress, San Francisco, July 2017.
5. Bergenstal RM, et al. Diabetes Care. 2017, DOI: 10.2337/dc16-0684.
6. 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) 26th Annual Scientific & Clinical Congress, Austin, TX, U.S., May 3–7 2017.
7. 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.

SOURCE Sanofi