Consistent A1C reduction across EDITION pivotal trials

Toujeo® vs Lantus® (insulin glargine injection) 100 Units/mL: PK/PD and pivotal data

In a PK/PD study

Longer-lasting, glucose lowering effect up to 36 hours¹,²

  • These PK/PD data do not support a comparison of the safety or efficacy of Toujeo and Lantus

Time course effect following product administration (N=30)
Once-daily Toujeo should be injected at the same time each day

    Clamp Study I: The pharmacodynamics of Toujeo at steady state after 8 days of daily injections was evaluated against Lantus in a euglycemic clamp study of patients with T1DM (N=30) receiving injections of 0.4 U/kg once daily. The dose on day 8 was followed by a 36-hour euglycemic clamp.2
     

In pivotal trials

Consistent A1C reduction and demonstrated safety in a broad range of adult patients1

Select a patient with Type 1 or Type 2 Diabetes below to see efficacy and safety results from the 4 EDITION clinical studies

  • Mean A1C change at 26 weeks vs -0.87% for Lantus*
     

    Incidence of severe hypoglycemia
     

    Incidence of hypoglycemia

     


    *Mean baseline A1C 8.13 for Toujeo, 8.14 for Lantus.1

    Most common adverse events (with incidence ≥5%) with Toujeo in patients with T2DM were nasopharyngitis (7.1%) and upper respiratory tract infection (5.7%).1

    • In all the EDITION studies, Toujeo met the primary endpoint (prespecified noninferiority margin of 0.4% and the 95% Cl) at 26 weeks1
    • In clinical trials, Toujeo patients used more basal insulin than Lantus patients (11% to 15% in T2DM, 17.5% in T1DM)1
    • To minimize the risk of hypoglycemia, titrate the dose of Toujeo no more frequently than every 3 to 4 days1
  • Mean A1C change at 26 weeks vs -0.70% for Lantus*
     

    Incidence of severe hypoglycemia
     

    Incidence of hypoglycemia

     


    *Mean baseline A1C 8.27 for Toujeo, 8.22 for Lantus.1

    Most common adverse events (with incidence ≥ 5%) with Toujeo in patients with T2DM were nasopharyngitis (7.1%) and upper respiratory tract infection (5.7%).1

    • In all the EDITION studies, Toujeo met the primary endpoint (prespecified noninferiority margin of 0.4% and the 95% Cl) at 26 weeks1
    • In clinical trials, Toujeo patients used more basal insulin than Lantus patients (11% to 15% in T2DM, 17.5% in T1DM)1
    • To minimize the risk of hypoglycemia, titrate the dose of Toujeo no more frequently than every 3 to 4 days1
  • Mean A1C change at 26 weeks vs -1.46% for Lantus*
     

    Incidence of severe hypoglycemia
     

    Incidence of hypoglycemia

     


    *Mean baseline A1C 8.49 for Toujeo, 8.58 for Lantus.1

    Most common adverse events (with incidence ≥5%) with Toujeo in patients with T2DM were nasopharyngitis (7.1%) and upper respiratory tract infection (5.7%).1

    • Incidence of severe hypoglycemia when part of a multiple-dose injection regimen: 6.6% in T1DM, 5% in T2DM; when part of a basal insulin-only regimen: 1.0% and 0.9% in two T2DM studies1
    • In all the EDITION studies, Toujeo met the primary endpoint (prespecified noninferiority margin of 0.4% and the 95% Cl) at 26 weeks1
    • In clinical trials, Toujeo patients used more basal insulin than Lantus patients (11% to 15% in T2DM, 17.5% in T1DM)1
    • To minimize the risk of hypoglycemia, titrate the dose of Toujeo no more frequently than every 3 to 4 days1
  • Mean A1C change at 26 weeks vs -0.44% for Lantus*
     

    Incidence of severe hypoglycemia
     

    Incidence of hypoglycemia

     


    *Mean baseline A1C 8.13 for Toujeo, 8.12 for Lantus.1

    Most common adverse events (with incidence ≥5%) with Toujeo in patients with T1DM were nasopharyngitis (12.8%) and upper respiratory tract infection (9.5%).1

    • In all the EDITION studies, Toujeo met the primary endpoint (prespecified noninferiority margin of 0.4% and the 95% Cl) at 26 weeks1
    • In clinical trials, Toujeo patients used more basal insulin than Lantus patients (11% to 15% in T2DM, 17.5% in T1DM)1
    • To minimize the risk of hypoglycemia, titrate the dose of Toujeo no more frequently than every 3 to 4 days1

There were no clinically important differences in body weight between treatment groups.1
OADs, oral antidiabetic drugs; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus.

Severe hypoglycemia: an event requiring assistance of another person to actively administer a resuscitative action.
Documented symptomatic hypoglycemia <3.0 mmol/L (<54 mg/dL).

    All studies were 26-week, open label, controlled, titrate-to-target, noninferiority studies in adults with diabetes not at A1C goal (range: 7% to 10% or 11%) randomized to Toujeo or Lantus once daily. All patients were titrated to an FPG goal of 80-100 mg/dL (T2DM) or 80-130 mg/dL (T1DM).1,3-6
     

Toujeo Dosing Calculator

Calculate the suggested starting dose for your patients with T2DM

Toujeo vs Tresiba®

View BRIGHT head-to-head study vs Tresiba
 

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. Toujeo Prescribing Information. 2. Becker RH, Dahmen R, Bergmann K, et al. Diabetes Care. 2015;38(4): 637-643.doi:10.2337/dc14-0006 3. Riddle MC, Bolli GB, Ziemen M, et al. Diabetes Care. 2014;37(10):2755-2762. doi:10.2337/dc14-0991 4. Yki-Järvinen H, Bergenstal R, Ziemen M, et al. Diabetes Care. 2014;37(12):3235-3243. doi:10.2337/dc14-0990 5. Bolli GB, Riddle MC, Bergenstal RM, et al. Diabetes Obes Metab. 2015;17(4):386-394. doi:10.1111/dom.12438 6. Home PD, Bergenstal RM, Bolli GB, et al. Diabetes Care. 2015;38(12):2217-2225. doi.org/10.2337/dc15-0249

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. Toujeo Prescribing Information. 2. Becker RH, Dahmen R, Bergmann K, et al. Diabetes Care. 2015;38(4): 637-643.doi:10.2337/dc14-0006 3. Riddle MC, Bolli GB, Ziemen M, et al. Diabetes Care. 2014;37(10):2755-2762. doi:10.2337/dc14-0991 4. Yki-Järvinen H, Bergenstal R, Ziemen M, et al. Diabetes Care. 2014;37(12):3235-3243. doi:10.2337/dc14-0990 5. Bolli GB, Riddle MC, Bergenstal RM, et al. Diabetes Obes Metab. 2015;17(4):386-394. doi:10.1111/dom.12438 6. Home PD, Bergenstal RM, Bolli GB, et al. Diabetes Care. 2015;38(12):2217-2225. doi.org/10.2337/dc15-0249