Patient-Driven Dose Titration with Sanofi's Toujeo Improved Blood Glucose Control Without Increasing Hypoglycemia Risk in Real-Life Clinical Practice

LISBON, Portugal, Sept. 14, 2017 /PRNewswire/ -- A new randomized clinical trial, TAKE CONTROL¹, demonstrated better control of blood sugar (HbA_1c) without increasing the risk of hypoglycemia in people with type 2 diabetes (T2D) by using Toujeo^® (insulin glargine 300 Units/mL, Gla-300) with a simple dose titration regimen ("patient-driven titration") compared with patients whose dose adjustment was managed by their physician ("physician-driven titration").

Participants initiated basal insulin with Toujeo or switched to Toujeo from another basal insulin (including insulin glargine 100 Units/mL, insulin detemir and NPH), while maintaining any previously administer oral antidiabetic drugs (OADs). After 6 months, patients with type 2 diabetes who used patient-driven titration achieved improvement of HbA_1c (LS mean difference 0.13%, p=0.0247) compared with those who followed physician-driven titration. The proportion of patients reaching the pre-defined blood glucose target without experiencing severe and/or confirmed hypoglycemia was 67.5% in the patient-driven titration group, compared with 58.4% in the group using physician-driven titration (RR 1.15 [1.02; 1.3], p=0.0187). Similar proportions of patients in both groups (6.4% vs. 6.3%), experienced at least one severe and/or confirmed (<54 mg/dL) hypoglycemic event. Full results will be presented in 2018.

"The results of the TAKE CONTROL study demonstrate that patients can make a critical contribution to work toward their own effective blood sugar target when they are well trained and using a basal insulin such as Toujeo," said Riccardo Perfetti, Vice-President Medical Affairs, DCV Medical Affairs, Sanofi. 

Sanofi is conducting a vast comparative Real-World program in routine clinical practice that covers more than 200,000 patients from U.S. and EU databases. Comparative data in a real-world setting can be relevant for payors and other organizations evaluating how findings from clinical trials can be translated into day-by-day management of diabetes. Two comparative retrospective observational studies, DELIVER 2² and DELIVER 3³, have been presented previously. Additional Real-World Evidence is expected to be submitted for publication this year. 

TAKE CONTROL design and study results
TAKE CONTROL is a 24 weeks, open-label, 1:1 ratio randomized, controlled, 2-arm parallel-group, multicenter, multinational study, comparing Gla-300 treatment of people with uncontrolled type 2 diabetes (T2DM), based on a titration algorithm managed by the patient vs Gla-300 treatment based on a titration algorithm managed by the physician. The primary objective was to demonstrate non-inferiority in terms of glycemic control, measured as change from baseline to Week 24 in HbA_1c. Patients remained on any previously-taken oral antidiabetic drugs (OADs).

This study included 631 patients with uncontrolled T2DM at screening (62% on basal insulin, 38% insulin-naive), a mean age of 63 years old and a median duration of diabetes of 12 years. The difference in mean HbA_1c reduction was -0.13% in favor of patient-driven titration (p<0.0001 for non-inferiority; a subsequent test calculated p=0.0247 for superiority, meeting a requirement of p=0.025). The percentage of patients achieving composite endpoint (defined as a secondary endpoint) of reaching the pre-defined fasting self-measured plasma glucose (SMPG) target of 80-130mg/dL without experiencing severe and/or confirmed hypoglycemia at week 24, was in favor of patient-driven titration group. Overall, at least one episode of hypoglycemia was reported by 36.2% of patients in the patient-driven titration group and by 37.0% of patients in the physician-driven titration group. Severe hypoglycemia was reported in 0.6% of patients in the patient-driven titration group, and 0.3% of patients [0.3%] in the physician-driven titration group.

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. Sanofi, data on file: TAKE CONTROL study, EUdraCT number 2015-001626-42, September 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) 26th Annual Scientific & Clinical Congress, Austin, TX, U.S., May 3–7 2017.
3. 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.

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