Positive results in Phase 3 trial for Toujeo® in children and adolescents with type 1 diabetes

Published

BRIDGEWATER, N.J., Nov. 4, 2019 /PRNewswire/ -- Children and adolescents (aged 6 to 17 years) living with type 1 diabetes achieved comparable reduction in average blood sugar (HbA1c) and similar risk of low blood sugar events with Toujeo® (insulin glargine injection) 300 Units/mL compared to insulin glargine 100 Units/mL (Gla-100), according to results presented at the International Society for Pediatric and Adolescent Diabetes 45th Annual Conference in Boston, Massachusetts.1

"We know that living with type 1 diabetes means dealing with highs and lows in blood sugar, which are worrying and present substantial challenges for young people," said Prof. Dr. Thomas Danne, Director of the Department of General Pediatrics and Endocrinology/Diabetology at the Children's Hospital On the Bult, Hannover Medical School, Germany. "In addition to the trial demonstrating safety and efficacy, the percentage of patients with severe hypoglycemia, and the percentage with hyperglycemia with ketosis, were numerically lower with Toujeo."

The trial, EDITION JUNIOR, is the first randomized, controlled trial comparing Toujeo vs Gla-100 in this group of patients. The study met its primary endpoint with comparable reductions in average blood sugar over 6 months with both treatments and similar risk of low blood sugar events (hypoglycemia). The percentages of patients who experienced severe hypoglycemia and who experienced high blood sugar (hyperglycemia) with ketosis were numerically lower with Toujeo. As these are serious short-term complications, these findings are clinically important for people with type 1 diabetes.

"Across the globe, between 50 and 80 percent of young people living with type 1 diabetes need more treatment options to help them achieve an average blood sugar level below 7.5%," said Dietmar Berger, Global Head of Development at Sanofi. "By taking this step toward investigating an additional option for children and adolescents living with diabetes, we hope to provide another treatment for them and their physicians, to develop an individualized treatment plan that helps patients better manage their disease."

About the study

The EDITION JUNIOR study1 compared Toujeo to Gla-100 in 463 children and adolescents (aged 6 to 17 years) treated for type 1 diabetes for at least one year and with HbA1c between 7.5% and 11.0% at screening. Participants continued to use their existing mealtime insulin.

The study met its primary endpoint, confirming non-inferior reduction of HbA1c with Toujeo vs Gla-100 after 26 weeks (mean reduction 0.4% vs 0.4%; difference: 0.004%, 95% CI -0.17 to 0.18; upper bound was below the pre-specified non-inferiority margin of 0.3%).

Over the same period, a comparable number of patients experienced one or more anytime (24h) documented low blood sugar (hypoglycemia) events. Numerically fewer patients using Toujeo experienced severe hypoglycemia, or experienced one or more episodes of high blood sugar (hyperglycemia) with ketosis compared, with those using Gla-100.

The number of adverse events was comparable between the two treatment groups (65.2% vs 65.8% of patients reported any treatment-emergent adverse event). No unexpected safety concerns were reported, based on the established profiles of both products.

Toujeo (n=233) Gla-100(n=228)
One or more event of severe and/or documented (≤ 70 mg/dL) hypoglycemia (24 h) 226 (97%) 223 (97.8%)
RR: 0.9995% CI: 0.96 to 1.02
One or more event of severe and/or documented(< 54 mg/dL) hypoglycemia (24 h) 187 (80.3%) 191 (83.8%)
RR: 0.9695% CI: 0.88 to 1.04
One or more episode of severe hypoglycemia (24 h) 14 (6.0%) 20 (8.8%)
RR: 0.6895% CI (0.35 to 1.30)
One or more event of hyperglycemia with ketosis (ketones ≥1.5 mmol/L) 19 (8.2%) 26 (11.4%)

The study design includes a further 6-month safety follow-up period, which will be reported separately.

The safety and efficacy of Toujeo in the adolescent population is currently under regulatory review in the US. The safety and efficacy for this use has not been fully evaluated.

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 share your pen(s) with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

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. 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 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 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:

Toujeo (n=233) Gla-100(n=228) 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
One or more event of severe and/or documented (≤ 70 mg/dL) hypoglycemia (24 h) 226 (97%) 223 (97.8%)
RR: 0.9995% CI: 0.96 to 1.02
One or more event of severe and/or documented(< 54 mg/dL) hypoglycemia (24 h) 187 (80.3%) 191 (83.8%)
RR: 0.9695% CI: 0.88 to 1.04
One or more episode of severe hypoglycemia (24 h) 14 (6.0%) 20 (8.8%)
RR: 0.6895% CI (0.35 to 1.30)
One or more event of hyperglycemia with ketosis (ketones ≥1.5 mmol/L) 19 (8.2%) 26 (11.4%)

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® and Toujeo® Max SoloStar® are disposable prefilled insulin pens. It is important to perform a safety test when using a new pen for the first time. 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.

References

  1. Danne T et al., "Insulin Glargine 300 U/mL (Gla-300) provides effective glycemic control in youths with type 1 diabetes (T1D): the EDITION JUNIOR study", Poster presentation P240, ISPAD 45th Annual Conference, Boston MA, U.S., October 31, 2019. Available via http://www.professionalabstracts.com/ispad2019/Iplanner/#/presentation/216 [Accessed October 2019].

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

Toujeo (n=233) Gla-100(n=228) 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 Media Relations Contact Investor Relations Contact
One or more event of severe and/or documented (≤ 70 mg/dL) hypoglycemia (24 h) 226 (97%) 223 (97.8%) Nicolas Kressmann George Grofik
RR: 0.9995% CI: 0.96 to 1.02 Tel.: +1 (732) 532 5318 Tel.: +33 (0)1 53 77 45 45
One or more event of severe and/or documented(< 54 mg/dL) hypoglycemia (24 h) 187 (80.3%) 191 (83.8%) Nicolas.Kressmann@sanofi.com   ir@sanofi.com 
RR: 0.9695% CI: 0.88 to 1.04
One or more episode of severe hypoglycemia (24 h) 14 (6.0%) 20 (8.8%)
RR: 0.6895% CI (0.35 to 1.30)
One or more event of hyperglycemia with ketosis (ketones ≥1.5 mmol/L) 19 (8.2%) 26 (11.4%)

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, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the  ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic conditions, 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, 2018. 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 (EURONEXT: SAN) (NASDAQ: SNY)

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