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Consistent A1C reduction across

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

Once-daily Toujeo should be injected at the same time each day (N=30)

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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 a PK/PD study

Blood glucose levels within the ADA-recommended range throughout the day2,3

This PK/PD study describes the time course effect following Toujeo administration.

Once-daily Toujeo should be injected at the same time each day (N=30)

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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

ADA, American Diabetes Association; BG, blood glucose; GIR, glucose infusion rate; PD, pharmacodynamics; PK, pharmacokinetics; T1DM, type 1 diabetes mellitus.

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.

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

  • 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%-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
Read the EDITION 1 study abstract at PubMed.gov

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.

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

  • 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%-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
Read the EDITION 2 study abstract at PubMed.gov

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.

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

  • 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%-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
Read the EDITION 3 study abstract at PubMed.gov

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.

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

  • 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%-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
Read the EDITION 4 study abstract at PubMed.gov

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.

‡Hypoglycemia defined as self-monitored or plasma glucose value <54 mg/dL regardless of symptoms.

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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

Toujeo Dosing Calculator

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Toujeo vs Tresiba®

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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

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® (insulin glargine injection) 300 Units/mL 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.

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*

*Eligibility Restrictions & Offer Terms:

This offer is not valid for prescriptions covered by or submitted for reimbursement under Medicare, Medicaid, VA, DOD, TRICARE, or similar federal or state programs including any state pharmaceutical assistance program. If you have an Affordable Care (Health Care Exchange) plan, you may still be qualified to receive and use this savings card. Please note: the Federal Employees Health Benefits (FEHB) Program is not a federal or state government health care program for purposes of the savings program. Void where prohibited by law.

  • Toujeo: pay as low as $0 up to $99 for a 30-day supply, depending on insurance coverage. Maximum savings apply. Valid up to 10 packs per fill; Offer valid for one fill per 30-day supply

Savings may vary depending on patients’ out-of-pocket costs. Upon registration, patients receive all program details. Sanofi US reserves the right to change the maximum cap amount, rescind, revoke or amend these programs without notice.

*Eligibility Restrictions & Offer Terms:

Insulins Valyou Savings Program: Sanofi insulins included in this program are: ADMELOG® (insulin lispro injection) 100 Units/mL, TOUJEO® (insulin glargine injection) 300 Units/mL, LANTUS® (insulin glargine injection) 100 Units/mL and APIDRA® (insulin glulisine injection) 100 Units/mL.

This offer is not valid for prescriptions covered by or submitted for reimbursement under Medicare, Medicaid, VA, DOD, TRICARE, similar federal or state programs, including any state pharmaceutical programs, or commercial / private insurance. Only people without prescription medication insurance can apply for this offer. Void where prohibited by law. For the duration of the program, eligible patients will pay $99 for up to 10 vials or packs of pens per fill. Offer valid for one fill per month. To pay $99 per month, you must fill all your Sanofi Insulin prescriptions at the same time, together each month. Not valid for SOLIQUA 100/33 (insulin glargine and lixisenatide injection) 100 Units/mL and 33 mcg/mL or Toujeo Max SoloStar pen. When using the Insulins Valyou Savings Card, prices are guaranteed for 12 consecutive monthly fills. The Insulins Valyou Savings Program applies to the cost of medication. There are other relevant costs associated with overall treatment.  

Sanofi Copay Program:This offer is not valid for prescriptions covered by or submitted for reimbursement under Medicare, Medicaid, VA, DOD, TRICARE, or similar federal or state programs including any state pharmaceutical assistance program. If you have an Affordable Care (Health Care Exchange) plan, you may still be qualified to receive and use this savings card. Please note: the Federal Employees Health Benefits (FEHB) Program is not a federal or state government health care program for purposes of the savings program. Void where prohibited by law.

  • Toujeo: pay as low as $0 up to $99 for a 30-day supply, depending on insurance coverage. Valid up to 10 packs per fill; Offer valid for one fill per 30-day supply

Savings may vary depending on patients’ out-of-pocket costs. Upon registration, patients receive all program details. Sanofi US reserves the right to change the maximum cap amount, rescind, revoke or amend these programs without notice.

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References:

  1. 1. Toujeo Prescribing Information.
  2. 2. Becker RH, Dahmen R, Bergmann K, Lehmann A, Jax T, Heise T. Diabetes Care. 2015;38(4):637-643.
  3. 3. American Diabetes Association. Diabetes Care. 2018;41(suppl 1):S1-S156.
  4. 4. Riddle MC, Bolli GB, Ziemen M, et al; the EDITION 1 study investigators. Diabetes Care. 2014;37(10):2755-2762.
  5. 5. Yki-Järvinen H, Bergenstal R, Ziemen M, et al; the EDITION 2 study investigators. Diabetes Care. 2014;37(12):3235-3243.
  6. 6. Bolli GB, Riddle MC, Bergenstal RM, et al; the EDITION 3 study investigators. Diabetes Obes Metab. 2015;17(4):386-394.
  7. 7. Home PD, Bergenstal RM, Bolli GB, et al. Diabetes Care. 2015;1-18.

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MAT-US-2012182 Last Update: June 2020

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 cautiously and only under medical supervision. Changes in insulin