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Toujeo® U-300 (insulin glargine) injection 300 Units/mL EDITION Pivotal Trials1-4

Toujeo® a longer-acting basal insulin with proven A1C reduction and demonstrated safety profile across EDITION pivotal trials1-4

Toujeo® Max SoloStar® pen within a yellow-green gradient circle.

In a PK/PD study: A longer-lasting, glucose-lowering effect vs Lantus®5,6

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)5,6

Once-daily Toujeo® should be injected at the same time each day.

Line graph showing glucose infusion rate (GIR) profiles of Toujeo (green line) and Lantus (gray line) over 36 hours following subcutaneous injection. The x-axis shows time in hours (0 to 36), and the y-axis shows GIR in mg/min/kg. A blue dotted vertical line marks the 24-hour point. A green box in the top right corner reads Up to 36 HOURS¹⁻² with a clockwise clock icon.

These PK/PD data do not support a comparison of the safety or efficacy of Toujeo and Lantus. 5,6

In pivotal trials, proven A1C reduction and established safety profile in a broad range of adult patients1-4,6

Click on a tab to see efficacy and safety results for each of the EDITION clinical trials.

T2DM: Insulin-naive and previously on OADs1

Omar Age 50, BMI 29 kg/m², A1C 8.6. Edition 3 study (n=862) A1C with green arrow pointing down -1.42% mean reduction in A1C²,³* at 26 weeks vs -1.46% for Lantus. Teardrop shape with 9% Incidence of hypoglycemia²†. Triangle with exclamation point 0.9% incidence of severe hypoglycemia²,³‡.

Most common adverse events (with incidence ≥5%) with Toujeo in patients with T2DM were nasopharyngitis (7.1%) and upper respiratory tract infection (5.7%).6

  • 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 studies6
  • In all the EDITION studies, Toujeo met the primary endpoint (prespecified noninferiority margin of 0.4% and the 95% CI) at 26 weeks6
  • In clinical trials, patients on Toujeo used more basal insulin than patients on Lantus (11%-15% in T2DM; 17.5% in T1DM)6
  • To minimize the risk of hypoglycemia, titrate the dose of Toujeo no more frequently than every 3 to 4 days6
     
  • Hypoglycemia is the most common adverse event associated with insulin-containing therapies

Download the full EDITION 3 study

T1DM: Previously on basal and mealtime insulin2

Elena age 45, BMI 31 kg/m², A1C 8.5. Edition 4⁴ (N=546). A1C with green arrow pointing down -0.40% Mean A1C change at 26 weeks vs -0.44% for Lantus²,⁴*. Teardrop shape 77.7% Incidence of hypoglycemia²⁺. Triangle with exclamation point inside 6.6% Incidence of severe hypoglycemia²,⁴‡.

Most common adverse events (with incidence ≥5%) with Toujeo in patients with T1DM were nasopharyngitis (12.8%) and upper respiratory tract infection (9.5%).6

  • 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 studies6
  • In all the EDITION studies, Toujeo met the primary endpoint (prespecified noninferiority margin of 0.4% and the 95% CI) at 26 weeks6
  • In clinical trials, patients on Toujeo used more basal insulin than patients on Lantus (11%-15% in T2DM; 17.5% in T1DM)6
  • To minimize the risk of hypoglycemia, titrate the dose of Toujeo no more frequently than every 3 to 4 days6
  • Hypoglycemia is the most common adverse event associated with insulin-containing therapies

Download the full EDITION 4 study

T2DM: Previously on basal and mealtime insulin3

Frank age 48, BMI 34 kg/m², A1C 8.8. Edition 1²,⁵ (N=804). A1C with green arrow pointing down -0.91% mean A1C change at 26 weeks vs -0.87% for Lantus²*. Teardrop shape 44.6% Incidence of hypoglycemia²†. Triangle with exclamation point 5% Incidence of Severe hypoglycemia²,⁵‡.

Most common adverse events (with incidence ≥5%) with Toujeo in patients with T2DM were nasopharyngitis (7.1%) and upper respiratory tract infection (5.7%).6

  • 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 studies6
  • In all the EDITION studies, Toujeo met the primary endpoint (prespecified noninferiority margin of 0.4% and the 95% CI) at 26 weeks6
  • In clinical trials, patients on Toujeo used more basal insulin than patients on Lantus (11%-15% in T2DM; 17.5% in T1DM)6
  • To minimize the risk of hypoglycemia, titrate the dose of Toujeo no more frequently than every 3 to 4 days6
  • Hypoglycemia is the most common adverse event associated with insulin-containing therapies

Download the full EDITION 1 study

T2DM: Previously on basal insulin and OADs4

Julie age 72, BMI 39kg/m², A1C 7.8. Edition 2² (N=808). A1C with green arrow pointing down -0.73% mean A1C change at 26 weeks vs -0.70% for Lantus²*. Teardrop shape 20.6% Incidence of hypoglycemia⁶†. Triangle with exclamation point 1.0% Incidence of severe hypoglycemia⁶‡.

Most common adverse events (with incidence ≥5%) with Toujeo in patients with T2DM were nasopharyngitis (7.1%) and upper respiratory tract infection (5.7%).6

  • 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 studies6
  • In all the EDITION studies, Toujeo met the primary endpoint (prespecified noninferiority margin of 0.4% and the 95% CI) at 26 weeks6
  • In clinical trials, patients on Toujeo used more basal insulin than patients on Lantus (11%-15% in T2DM; 17.5% in T1DM)6
  • To minimize the risk of hypoglycemia, titrate the dose of Toujeo no more frequently than every 3 to 4 days6
  • Hypoglycemia is the most common adverse event associated with insulin-containing therapies

Download the full EDITION 2 study

There were no clinically important differences in body weight between treatment groups.6
†Documented symptomatic hypoglycemia <3.0 mmol/L (<54 mg/dL).1
‡Severe hypoglycemia: an event requiring assistance of another person to actively administer a resuscitative action.6

Two insulin pens in a green circle with yellow green gradient box.

See the Toujeo vs Tresiba® studies

See how Toujeo did in head-to-head studies vs Tresiba.

SEE THE DATA
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Interactive Dosing Calculator for T2DM patients

Calculate the number of units (including titration estimate), mLs, and boxes to include on 30- or 90-day prescriptions. Writing this information on a prescription may reduce rejections at the pharmacy.

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Important Safety Information

Contraindications

Toujeo is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin glargine or any of the excipients in Toujeo.

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 (U-300).

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. Dosage adjustments are recommended to lower the risk of hypoglycemia when switching patients to Toujeo from another insulin therapy.

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 switched to, Toujeo required a higher dose than patients controlled with Lantus. When switching 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 in patients treated with Toujeo and may be life-threatening. The long-acting effect of Toujeo may delay recovery from hypoglycemia compared to shorter-acting insulins.

Medication errors that may lead to hypoglycemia, such as accidental mix-ups between insulin products, 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.

All insulins, including Toujeo, 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 dosage 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, hypersensitivity reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.

Important Safety Information for Toujeo U-300 (insulin glargine) injection 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 their 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.

Indication

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 the treatment of diabetic ketoacidosis.

Click here for Full Prescribing Information for Toujeo.
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Important Safety Information

Indication

A1C, glycated hemoglobin; FPG, fasting plasma glucose; GIR, glucose infusion rate; OAD, oral antidiabetic drug; PD, pharmacodynamics; PK, pharmacokinetics; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus.

References:

1. Bolli GB, et al. Diabetes Obes Metab. 2015;17(4):386-394. 2. Home PD, et al. Diabetes Care. 2015;38(12):2217-2225. 3. Riddle MC, et al. Diabetes Care. 2014;37(10):2755-2762. 4. Yki-Järvinen H, et al. Diabetes Care. 2014;37(12):3235-3243. 5. Becker RHA, et al. Diabetes Care. 2015;38(4):637-643. 6. Toujeo Prescribing Information. Sanofi.

LANTUS, TOUJEO, SoloStar, TOUJEO Max SoloStar, Sanofi Patient Connection, and Sanofi are registered trademarks of Sanofi or an affiliate. All the other trademarks above are the property of their respective owners, who have no affiliation or relationship with Sanofi. MAT-US-2209117-v5.0-10/2025

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