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

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 (HbA_1c) 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 45^th 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 HbA_1c 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 HbA_1c 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.

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^® 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

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