Toujeo® improved results in adults with type 2 diabetes and moderate to severe renal impairment compared to Tresiba®
  • Improved blood sugar control without increased risk of low blood sugar incidence or events were demonstrated in a predefined sub-analysis of a head-to-head study presented at the American Diabetes Association (ADA) Scientific Sessions

June 9, 2019

In a predefined sub-analysis of the BRIGHT head-to-head study evaluating Toujeo® (insulin glargine injection) 300 Units/mL with Tresiba® (insulin degludec), Toujeo resulted in greater improvement in blood sugar control (HbA1c) compared to Tresiba (-1.72% vs. -1.30%, respectively) with no difference in incidence or event rates of confirmed low blood sugar (hypoglycemia) in adults with type 2 diabetes and moderately to severely impaired renal function (eGFR <60 mL/min/1.73 m2). The data was presented at the ADA 79th Scientific Sessions in San Francisco.

“As many as 30-40 percent of people with type 2 diabetes will develop renal impairment due to diabetic kidney disease and are often considered challenging to treat because of their high risk for hypoglycemia as many will eventually need insulin therapy,” said Athena Philis-Tsimikas, MD, Corporate Vice President, Scripps Whittier Diabetes Institute at Scripps Health, San Diego, California, and an investigator of the study. “This new BRIGHT sub-analysis in patients who had moderate to severe renal impairment demonstrated that insulin glargine 300 Units/mL had greater improvement in blood sugar control compared to insulin degludec with comparable rates of hypoglycemia between the two treatment groups.”


Further results showed adults with type 2 diabetes and normal renal function (eGFR ≥90 mL/min/1.73 m2) demonstrated a lower event rate of anytime confirmed low blood sugar with Toujeo compared to Tresiba (6.5 vs. 10.4 events per patient-year, respectively) with comparable blood sugar control and incidence of confirmed low blood sugar. For those with mildly impaired renal function (eGFR 60-90 mL/min/1.73 m2), blood sugar control and incidence and event rates of confirmed low blood sugar were comparable.

“This new analysis illustrates our commitment to better understand and our desire to help address the needs of adults living with diabetes, including those whose disease may be more challenging to manage, such as those with renal impairment,” said Christopher Sorli, MD, PhD, Vice President Medical Affairs, Head of Diabetes US, Sanofi. “With frequent blood sugar monitoring and dose adjustments as necessary, Toujeo could be an option to help those with impaired renal function improve their blood sugar control.”


BRIGHT Data Summary by Patient

eGFR subgroup, mL/min/1.73 m2






Mean change in HbA1c, %a


LS mean change from baseline (SE)

LS mean difference vs IDeg [95% CI]

≥90 (n=428)

−1.57 (0.05)

−1.67 (0.05)

0.09 [−0.05 to 0.24]

60–90 (n=337)

−1.72 (0.06)

−1.58 (0.06)

−0.14 [−0.30 to 0.02]

<60 (n=89)

−1.72 (0.11)

−1.30 (0.11)

−0.43 [−0.74 to −0.12]

Anytime (24 h) confirmed (≤70 mg/dL) hypoglycemia



Events/ patient-year

Rate ratiob Gla-300 vs IDeg [95% CI]

≥90 (n=462)



0.60 [0.45 to 0.81]

60–90 (n=365)



1.23 [0.93 to 1.64]

<60 (n=96)



0.93 [0.56 to 1.54]


Participants with ≥1 hypoglycemic event, %

Odds ratioc Gla-300 vs IDeg [95% CI]

≥90 (n=462)



0.74 [0.50 to 1.10]

60–90 (n=365)



1.14 [0.71 to 1.82]

<60 (n=96)



1.00 [0.35 to 2.81]

CI, confidence interval; eGFR, estimated glomerular filtration rate; LS, least squares

aLS mean data and 95% CI derived from a Mixed effect Model for Repeat Measurements (MMRM).

bRate ratios and CIs are based on an overdispersed Poisson regression model.

cOdds ratios and CIs are based on a logistic regression analysis.

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:

  • 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® 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 pens.

Please see full Prescribing Information.