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Toujeo® vs Tresiba®—glycemic variability and BRIGHT study results

In a PK/PD study

Lower or comparable within-day variability vs Tresiba

In patients with T1DM, within-day variability was lower or similar for Toujeo than Tresiba, depending on the dose administered.1

  • PK/PD data show the time course effect following product administration
  • These PK/PD data do not support a comparison of the safety and efficacy of Toujeo and Tresiba
  • Once-daily Toujeo should be injected at the same time each day

Mean glucose infusion rate over 30 hours at 0.4 U/kg

Mean glucose infusion rate over 30 hours at 0.6 U/kg

*Mean GIR fluctuation (SD):Toujeo 0.38 (0.17) mg/min/kg vs Tresiba 0.46 (0.19) mg/min/kg; treatment ratio 0.80 [90% Cl: 0.66 to 0.96], P=0.047.1

Mean GIR fluctuation (SD): Toujeo 0.45 (0.17) mg/min/kg vs Tresiba 0.48 (0.22) mg/min/kg; treatment ratio 0.96 [90% Cl: 0.83 to 1.11], P=0.603.1

PK/PD results will vary depending on multiple factors, including, but not limited to, injection site, dose and time of product administration, insulin properties, administration technique, and individualized patient physiologic factors.

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Randomized, double-blind, two-treatment, crossover euglycemic clamp study to compare the steady-state PK/PD profiles of Toujeo and Tresiba. The study included two cohorts that each evaluated a different dose of once-daily basal insulin (0.4 U/kg/day in cohort 1; 0.6 U/kg/day in cohort 2). AII study participants were adult patients with T1DM and received Toujeo (n=24) or Tresiba (n=24) subcutaneously once-daily before breakfast for 8 days. The insulin dose on Day 8 was given in fasting condition at approximately 8 AM and followed by a 30-hour euglycemic glucose clamp. The clamp was performed to the end of the study or stopped earlier if blood glucose levels exceeded 200 mg/dL for 30 minutes in the absence of an intravenous glucose infusion. Four clamps were excluded from the PD analysis because of insufficient clamp quality. The primary study endpoint was the fluctuation (within-day variability) of the smoothed glucose infusion rate (GIR) over 24 hours in steady state calculated from the area of individual smoothed GIR above and below the individual average GIR line.1



Safety Endpoints

Anytime hypoglycemia vs Tresiba over 24 weeks

Incidence and event rate of severe and/or confirmed anytime hypoglycemia (<54 mg/dL)2,3

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A multicenter, open-label, randomized, active-controlled, two-arm, parallel-group, noninferiority study comparing the efficacy and safety of Toujeo and Tresiba U100 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 U/Kg and 10 U once daily, respectively, in accordance with product label and the same insulin titration algorithm was followed. lnvestigational 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 80-100 mg/dL while avoiding hypoglycemia. The aim of the titration period (Day 1 to Week 12) was the achievement of the fasting SMPG target. The primary endpoint of this study was to demonstrate the noninferiority of Toujeo to Tresiba in A1C change from baseline to Week 24.2

The BRIGHT trial results

A video of the first head-to-head, randomized, controlled trial of Toujeo vs Tresiba, covering A1C data and hypoglycemia event rates

See savings offers for Toujeo

Toujeo has competitive co-pay savings offers for eligible patients with or without commercial insurance

Find your patients’ suggested dose

Once-daily dosing. Two device options.

Toujeo is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus.

Limitations of Use: Toujeo is not recommended for treating diabetic ketoacidosis.

Important Safety Information for Toujeo® (insulin glargine injection) 300 Units/mL

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 strength, manufacturer, type, 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.

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 (eg, 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 disposable 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 disposable prefilled pens with a syringe.

All registered trademarks cited are property of their respective owners.

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*Eligibility Restrictions & Offer Terms:

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. Important to note that 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 copay for the first 3 fills, then as low as $10 copay for the next 12 fills. Maximum savings up to $150 per pack up to 3 packs per fill;

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 is 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. Important to note that 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 copay for the first 3 fills, then as low as $10 copay for the next 12 fills. Maximum savings up to $150 per pack up to 3 packs per fill;

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.

References:

  1. 1. Bailey T, Pettus J, Roussel R, et al. Diabetes Metab. 2018;44(1):15-21.
  2. 2. Rosenstock J, Cheng A, Ritzel R, et al. Diabetes Care. 2018. doi:10.2337/dc18-0559.
  3. 3. Data on file. Clinical Study Report, Sanofi, NCT02738151.

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SAUS.TJO.19.01.0569a Last Update: May 2019

Important Safety Information for Toujeo® (insulin glargine injection) 300 Units/mL

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