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Review Toujeo pivotal trials and clinical publications online

Use the links below to read the study abstracts and full external publications.

BRIGHT

The first head-to-head, randomized controlled clinical trial of Toujeo vs Tresiba®.

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BAILEY

A PK/PD study evaluating the within-day variability of Toujeo and Tresiba in patients with T1DM.

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EDITION 3

Insulin-naive patients with type 2 diabetes mellitus on oral glucose-lowering drugs.

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EDITION 2

Patients with type 2 diabetes mellitus using oral antidiabetic agents and basal insulin.

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EDITION 1

Patients with type 2 diabetes mellitus using basal and mealtime insulin.

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EDITION 4

Patients with type 1 diabetes mellitus.

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Clamp Study I

Evaluated the steady-state PK/PD profile of Toujeo.

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Clamp Study II

Evaluated the day-to-day and intraday variability of Toujeo.

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Toujeo has been studied versus Lantus® (insulin glargine injection) 100 Units/mL in four pivotal clinical trials (the EDITION study program) involving more than 3000 patients and in two euglycemic clamp studies to assess pharmacokinetics (PK) and pharmacodynamics (PD).

All studies in the EDITION clinical program were 26-week, open-label, controlled, titrate-to-target, noninferiority studies in adults with diabetes not at A1C goal (range: 7%-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).

Toujeo Dosing Guide

Information on the initiation and titration of Toujeo

English

Toujeo SoloStar® Instructions for Use

Instructions for using the Toujeo SoloStar pen

English

Toujeo Max SoloStar Instructions for Use

Instructions for using the Toujeo Max SoloStar pen

English

Toujeo Titration Worksheet

Completed by a healthcare professional, this form provides dosing instructions to patients

English

Blood Sugar Log

Form for tracking blood glucose values through the week

EnglishSpanish

Meal Planning and Exercise Tips

Tips for keeping active to stay healthy

EnglishSpanish

How to Prepare for and Inject Toujeo

Instructions for using the Toujeo pens

English

Hypoglycemia Safety

Tips for patients about managing hypoglycemia

EnglishSpanish

Learn about the Toujeo Max SoloStar Pen Features

Key features of the Max SoloStar pen

English

Toujeo Max SoloStar Pharmacy FAQs

FAQs about the Max SoloStar pen

English

Insulin, Glucose and You

Insulin and Glucose

When you hear the word insulin, you may think of a drug taken by people who have diabetes.

While this is true, what you may not know is that insulin is one of the many hormones created in the human body.

Insulin is important to the body. It allows blood sugar (or glucose) to get into cells to provide them with energy.

When you eat, your body breaks down food into glucose in your small intestine.

This is your body’s source of energy for everything it does, from working and thinking to exercising and healing.

Glucose travels through your bloodstream, looking for individual cells that need energy.

For glucose to get into the cells, it requires insulin.

Insulin is the key that unlocks cells for glucose to enter and deliver energy.

When insulin arrives, it signals the cell to activate glucose transporters.

These transporters pull glucose through cell walls.

When glucose moves into the cell, it delivers energy.

Insulin Deficiency

Insulin is normally produced in the pancreas by specialized cells called beta cells.

When glucose enters your bloodstream, the pancreas matches it with the right amount of insulin to move glucose into your cells.

In people with diabetes, this process doesn't work as it should. In type 1 diabetes, scientists believe the body's immune system mistakenly attacks and destroys beta cells in the pancreas. A person with type 1 diabetes loses the ability to produce insulin.

In type 2 diabetes, the pancreas is not producing enough insulin to meet the body's needs. Over time, the amount of insulin typically becomes less and less.

Insulin Resistance

In some type 2 diabetes patients, cells build up a resistance to insulin. Even though there may be insulin in the bloodstream, it is not enough to unlock cells to allow glucose to enter.

As a result, it takes more insulin to find the right key to unlock the cell for glucose. This makes it more difficult for cells to get the energy they need.

The Effects of Diabetes

When glucose can't get into cells—either because there isn't enough insulin or because the body is resisting it—glucose begins to build up in the bloodstream.

As a result, all that energy is wasted. It does not get to cells where it is needed. Without glucose in your cells, they lack the energy they require to keep your body working.

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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.

All registered trademarks cited are property of their respective owners.

*

*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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MAT-US-2008796 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