Primary Endpoint
Change in glycated haemoglobin (HbA1C) from baseline to week 241
Safety Endpoint
Safety endpoints included incidence and rates of confirmed [≤70 mg/dL (≤3.9 mmol/L) and <54 mg/dL (<3.0 mmol/L)] hypoglycaemia over 24 weeks1*
Subgroup Analysis
Toujeo delivers greater A1C reduction in patients with renal insufficiency2,3
Renal function subgroups (eGFR ≥90 [normal], 60 to <90 [mild] and <60 mL/min/1.73 m2 [moderate/severe])3
The BRIGHT head-to-head study comparing Toujeo vs Tresiba supports the EDITION pivotal studies
Toujeo® vs Tresiba®: A1C reduction, hypoglycemia, and renal subgroup data
BRIGHT Subgroup Analysis
Toujeo delivers greater A1C reduction in patients with renal insufficiency1,2
A1C reduction was consistent with the BRIGHT primary endpoint.3
Comparable risk of hypoglycemia1,2
- Anytime (24h) confirmed (≤ 70 mg/dL) hypoglycemia events per patient year: Toujeo 6.5 vs Tresiba 10.4 (≥90 mL/min/1.73 m2); Toujeo 12.3 vs Tresiba 10.5 (60 to <90 mL/min/1.73 m2); Toujeo 13.5 vs Tresiba 13.9 (<60 mL/min/1.73 m2)2
Limitation: This exploratory subgroup analysis was not designed or powered to detect differences between treatment groups.
The effect of renal impairment on the pharmacokinetics of Toujeo has not been studied. Frequent glucose monitoring and dose adjustment may be necessary.
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BRIGHT Primary Endpoint
Powerful A1C reduction at 24 weeks with Toujeo3
†Baseline: 8.72% ± 0.83% for Toujeo, 8.57% ± 0.80% for Tresiba.3
‡At 24 weeks: 7.03% ± 0.79% for Toujeo, 7.03% ± 0.77% for Tresiba.3
- Noninferiority margin of 0.3% and difference between treatments of -0.05% (95% confidence interval -0.15 to 0.05%) at 24 weeks3
- The mean daily basal insulin dose on Day 1 was higher in the Toujeo group than in the Tresiba group: 16.86 Units and 10.15 Units, respectively. By Week 24, the mean daily basal insulin dose was 50.47 Units and 39.21 Units for Toujeo and Tresiba, respectively3
- Mean (±SD) body weight increased from baseline (90.6 ± 16.1 and 88.7 ± 15.9 kg with Toujeo and Tresiba, respectively) to Week 24 (92.5 ± 16.6 kg and 91.4 ± 16.7 kg), an absolute mean increase of 2.0 ± 3.8 kg with Toujeo and 2.3 ± 3.6 kg with Tresiba3
BRIGHT Safety Endpoint
Lower rates of hypoglycemia with Toujeo in the Titration Phase3§
- Incidence of severe and/or confirmed hypoglycemia was 7.8% for Toujeo (n=36) vs 11.7% for Tresiba (n=54) in the Titration Phase
Limitation: P values are for descriptive purposes only and are not adjusted for multiplicity.
- Incidence of severe and/or confirmed hypoglycemia was 7.8% for Toujeo (n=36) vs 11.7% for Tresiba (n=54) in the Titration Phase
- Incidence of severe and/or confirmed hypoglycemia was 9.8% for Toujeo (n=44) vs 11.2% for Tresiba (n=50) in the Maintenance Phase
Event rates were comparable for Maintenance Phase and Full Period.
§Anytime severe and/or confirmed hypoglycemia (<54 mg/dL).
- Incidence of severe and/or confirmed hypoglycemia (<54 mg/dL) for Toujeo was 14.7% (n=68) and 18.4% for Tresiba (n=85)
Limitations: P values are for descriptive purposes only and are not adjusted for multiplicity.
The most frequently reported TEAEs (≥5%) were viral upper respiratory tract infection reported in 8.2% in the Toujeo group and in 8.7% in the Tresiba group, and upper respiratory tract infection in 5.2% and 4.1%, respectively. Serious TEAEs were 4.5% for Toujeo vs 4.3% for Tresiba.6
- This trial was not designed to evaluate the relative safety of Toujeo compared with Tresiba, and comparator adverse event rates are not an adequate basis for comparison rates between the products
- Hypoglycemia events can vary among studies based on study design, method of collecting data, and hypoglycemia definitions. Hypoglycemia is the most frequently reported adverse event for all insulins. Therefore, each patient should be evaluated to determine individual risk and how to recognize hypoglycemic signs and symptoms and the actions to be taken should they occur
A multicenter, open-label, randomized, active-controlled, two-arm, parallel-group, noninferiority study comparing the efficacy and safety of Toujeo and Tresiba 100 Units/mL in adult insulin-naive patients with T2DM not adequately controlled with oral antidiabetic drug(s) ± a GLP-1 receptor agonist. Patients were randomized 1:1 to receive Toujeo (n=466) or Tresiba (n=463) subcutaneously between 6 pm and 8 pm over 24 weeks. The starting doses of Toujeo and Tresiba were 0.2 Units/kg and 10 Units once daily, respectively, in accordance with product label and the same insulin titration algorithm was followed. Investigational medicinal products (IMPs) were injected in the evening between 6 pm and 8 pm. Doses were adjusted at least weekly, but not more often than every 3 days, targeting a fasting self-monitored plasma glucose (SMPG) of 80 to 100 mg/dL while avoiding hypoglycemia. The aim of the titration period (Day 1 to Week 12) was the achievement of the fasting SMPG target.3
The primary endpoint of this study was to demonstrate the noninferiority of Toujeo to Tresiba in A1C change from baseline to Week 24.3
Samples
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Toujeo is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients 6 years and older with diabetes mellitus.
Limitations of Use: Toujeo is not recommended for treating diabetic ketoacidosis.
Important Safety Information
Important Safety Information
Contraindications
Toujeo is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin glargine or any of its excipients.
Warnings and Precautions
Toujeo contains the same active ingredient, insulin glargine, as Lantus®. The concentration of insulin glargine in Toujeo is 300 units per mL.
Insulin pens and needles must never be shared between patients. Do NOT reuse needles.
Monitor blood glucose in all patients treated with insulin. Modify insulin regimens only under medical supervision. Changes in insulin regimen, strength, manufacturer, type, injection site or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. Changes in insulin regimen may result in hyperglycemia or hypoglycemia.
Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis may result in hyperglycemia; sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia. Advise patients to rotate injection site to unaffected areas and closely monitor for hypoglycemia.
Unit for unit, patients started on, or changed to, Toujeo required a higher dose than patients controlled with Lantus. When changing from another basal insulin to Toujeo, patients experienced higher average fasting plasma glucose levels in the first few weeks of therapy until titrated to their individualized fasting plasma glucose targets. Higher doses were required in titrate-to-target studies to achieve glucose control similar to Lantus.
Hypoglycemia is the most common adverse reaction of insulin therapy, including Toujeo, and may be life-threatening.
Medication errors, such as accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. Patients should be instructed to always verify the insulin label before each injection.
Do not dilute or mix Toujeo with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer Toujeo via an insulin pump or intravenously because severe hypoglycemia can occur.
Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Toujeo, monitor and treat if indicated.
A reduction in the Toujeo dose may be required in patients with renal or hepatic impairment.
As with all insulins, Toujeo use can lead to life-threatening hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated.
Fluid retention, which may lead to or exacerbate heart failure, can occur with concomitant use of thiazolidinediones (TZDs) with insulin. These patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of TZD must be considered.
Drug Interactions
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).
Adverse Reactions
Adverse reactions commonly associated with Toujeo include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain.
Important Safety Information for Toujeo SoloStar® and Toujeo Max SoloStar®
Toujeo SoloStar and Toujeo Max SoloStar are single-patient-use prefilled insulin pens. To help ensure an accurate dose each time, patients should follow all steps in the Instruction Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin, which may affect their blood glucose levels. It is especially important to perform a safety test when a patient is using a new pen for the first time.
Do not withdraw Toujeo from the SoloStar and Max SoloStar single-patient-use prefilled pens with a syringe.
Click here for full Prescribing Information.
Click here for information on Sharps Medical Waste Disposal.
Click here to learn more about Sanofi's commitment to fighting counterfeit drugs.
All registered trademarks cited are property of their respective owners.
References: 1. Data on file. Clinical Study Report, LPS14584. Sanofi US 2018. 2. Haluzík M, Cheng A, Müeller-Wieland D, et al. Diabetes Obes Metab. 2020; 22:1369–1377. doi:10.1111/dom.14043 3. Rosenstock J, Cheng A, Ritze R, et al. Diabetes Care. 2018;41(10):2147-2154. doi:10.2337/do18-0559 4. Wu B, Bell K, Stanford A, et al. BMJ Open Diabetes Res Care. 2016;4: e000154. doi:10.1136/bmjdrc-2015-000154 5. National Diabetes Statistics Report. U.S. Centers for Disease Control and Prevention. 2020. 6. Data on file. Clinical Study Report, Sanofi, NCT02738151.
Important Safety Information
Read MoreImportant Safety Information
Contraindications
Toujeo is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin glargine or any of its excipients.
Warnings and Precautions
Toujeo contains the same active ingredient, insulin glargine, as Lantus®. The concentration of insulin glargine in Toujeo is 300 units per mL.
Insulin pens and needles must never be shared between patients. Do NOT reuse needles.
Monitor blood glucose in all patients treated with insulin. Modify insulin regimens only under medical supervision. Changes in insulin regimen, strength, manufacturer, type, injection site or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. Changes in insulin regimen may result in hyperglycemia or hypoglycemia.
Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis may result in hyperglycemia; sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia. Advise patients to rotate injection site to unaffected areas and closely monitor for hypoglycemia.
Unit for unit, patients started on, or changed to, Toujeo required a higher dose than patients controlled with Lantus. When changing from another basal insulin to Toujeo, patients experienced higher average fasting plasma glucose levels in the first few weeks of therapy until titrated to their individualized fasting plasma glucose targets. Higher doses were required in titrate-to-target studies to achieve glucose control similar to Lantus.
Hypoglycemia is the most common adverse reaction of insulin therapy, including Toujeo, and may be life-threatening.
Medication errors, such as accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. Patients should be instructed to always verify the insulin label before each injection.
Do not dilute or mix Toujeo with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer Toujeo via an insulin pump or intravenously because severe hypoglycemia can occur.
Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Toujeo, monitor and treat if indicated.
A reduction in the Toujeo dose may be required in patients with renal or hepatic impairment.
As with all insulins, Toujeo use can lead to life-threatening hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated.
Fluid retention, which may lead to or exacerbate heart failure, can occur with concomitant use of thiazolidinediones (TZDs) with insulin. These patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of TZD must be considered.
Drug Interactions
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).
Adverse Reactions
Adverse reactions commonly associated with Toujeo include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain.
Important Safety Information for Toujeo SoloStar® and Toujeo Max SoloStar®
Toujeo SoloStar and Toujeo Max SoloStar are single-patient-use prefilled insulin pens. To help ensure an accurate dose each time, patients should follow all steps in the Instruction Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin, which may affect their blood glucose levels. It is especially important to perform a safety test when a patient is using a new pen for the first time.
Do not withdraw Toujeo from the SoloStar and Max SoloStar single-patient-use prefilled pens with a syringe.
Click here for full Prescribing Information.
Click here for information on Sharps Medical Waste Disposal.
Click here to learn more about Sanofi's commitment to fighting counterfeit drugs.
All registered trademarks cited are property of their respective owners.
References: 1. Data on file. Clinical Study Report, LPS14584. Sanofi US 2018. 2. Haluzík M, Cheng A, Müeller-Wieland D, et al. Diabetes Obes Metab. 2020; 22:1369–1377. doi:10.1111/dom.14043 3. Rosenstock J, Cheng A, Ritze R, et al. Diabetes Care. 2018;41(10):2147-2154. doi:10.2337/do18-0559 4. Wu B, Bell K, Stanford A, et al. BMJ Open Diabetes Res Care. 2016;4: e000154. doi:10.1136/bmjdrc-2015-000154 5. National Diabetes Statistics Report. U.S. Centers for Disease Control and Prevention. 2020. 6. Data on file. Clinical Study Report, Sanofi, NCT02738151.