Healthcare professionals have chosen Lantus® for over 18 years1

LANTUS® EFFICACY AND SAFETY IN A RANDOMIZED TRIAL VS INSULIN DETEMIR2

Lantus® was evaluated for 52 weeks in insulin-naive adult patients with type 2 diabetes on OADs


A1C decreased by

1.5%

in the Lantus® and insulin detemir treatment groups and was comparable among groups after 52 weeks (7.1% for Lantus® and 7.2% for insulin detemir)

52% of participants in the study achieved A1C ≤7%

100% of Lantus® patients were dosed once a day throughout the study


Mean daily dose after 52 weeks (U/kg): insulin detemir twice daily 1.00, insulin detemir once daily 0.52, Lantus® 0.44

Safety results


Individuals treated with twice-daily insulin detemir had weight gain similar to those treated with once-daily Lantus®. Data are based on the intent-to-treat population.

a Major hypoglycemic event was defined as requiring assistance from another person.
b Minor hypoglycemia was defined as PG<56 mg/dL.

Study Design

An open-label, parallel-group, noninferiority trial of 582 insulin-naive patients with type 2 diabetes. Patients were randomized 1:1 to receive Lantus® (n=291) or insulin detemir (n=291) once daily (in the evening) as add-on therapy to oral glucose-lowering drugs. Both insulins were titrated to an FPG target of ≤108 mg/dL. An additional morning insulin dose of insulin detemir was allowed if pre-dinner PG was >126 mg/dL, but only if pre-breakfast PG was <126 mg/dL or nocturnal hypoglycemia (major episode or PG ≤72 mg/dL) precluded achievement of the FPG target. Participants were eligible if A1C ranged from 7.5% to 10%. Primary endpoint was change in A1C at end of treatment period.

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Lantus is a long-acting insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Lantus should be administered once a day at the same time every day.

Limitations of Use: Lantus is not recommended for the treatment of diabetic ketoacidosis.

Important Safety Information for Lantus®

Important Safety Information for Lantus®

Contraindications
Lantus is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin glargine or one of its excipients.
Warnings and Precautions
Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles.
Monitor blood glucose in all patients treated with insulin. Modify insulin regimen only under medical supervision. Changes in insulin regimen including, 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.
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.

Do not dilute or mix Lantus 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 Lantus via an insulin pump or intravenously because severe hypoglycemia can occur.

Hypoglycemia is the most common adverse reaction of insulin therapy, including Lantus, 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.

Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Lantus, treat and monitor until symptoms resolve.

A reduction in the Lantus dose may be required in patients with renal or hepatic impairment.

As with all insulins, Lantus 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 Lantus include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain.
Important Safety Information for Lantus® SoloSTAR®
Lantus SoloSTAR is a disposable single-patient-use prefilled insulin pen. 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.

Click here for Full Prescribing Information for Lantus.

Click here for information on Sharps Medical Waste Disposal.

Click here to learn more about Sanofi's commitment to fighting counterfeit drugs.

*Eligibility Restrictions & Offer Terms:

Insulins Valyou Savings Program: Sanofi insulins included in this program are: ADMELOG® (insulin lispro injection) 100 Units/mL, TOUJEO® SoloStar® (insulin glargine injection) 300 Units/mL, TOUJEO® Max SoloStar® (insulin glargine injection) 300 Units/mL, LANTUS® (insulin glargine injection) 100 Units/mL, INSULIN GLARGINE injection 100 Units/mL (U-100) 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 $35 per 30 Day Supply. To pay $35 per 30 Day Supply, 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. 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 reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms of use at any time without notice. Upon registration, patients will receive all program details.

Sanofi US 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 healthcare program for purposes of the savings program. Void where prohibited by law.

  • Lantus or Insulin Glargine U-100 (Winthrop): Pay as low as $0 up to $99 for a 30-day supply. Amount depends on insurance coverage. Valid up to 10 packs per fill; offer valid for 1 fill every thirty days.

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.

Reference:
1. Lantus® Prescribing Information.
2. Rosenstock J, Davies M, Home PD, et al. Diabetologia. 2008;51:408-416.

All registered trademarks cited are property of their respective owners.

Important Safety Information for Lantus®

Read More

Important Safety Information for Lantus®

Contraindications
Lantus is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin glargine or one of its excipients.
Warnings and Precautions
Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles.
Monitor blood glucose in all patients treated with insulin. Modify insulin regimen only under medical supervision. Changes in insulin regimen including, 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.
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.

Do not dilute or mix Lantus 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 Lantus via an insulin pump or intravenously because severe hypoglycemia can occur.

Hypoglycemia is the most common adverse reaction of insulin therapy, including Lantus, 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.

Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Lantus, treat and monitor until symptoms resolve.

A reduction in the Lantus dose may be required in patients with renal or hepatic impairment.

As with all insulins, Lantus 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 Lantus include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain.
Important Safety Information for Lantus® SoloSTAR®
Lantus SoloSTAR is a disposable single-patient-use prefilled insulin pen. 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.

Click here for Full Prescribing Information for Lantus.

Click here for information on Sharps Medical Waste Disposal.

Click here to learn more about Sanofi's commitment to fighting counterfeit drugs.

*Eligibility Restrictions & Offer Terms:

Insulins Valyou Savings Program: Sanofi insulins included in this program are: ADMELOG® (insulin lispro injection) 100 Units/mL, TOUJEO® SoloStar® (insulin glargine injection) 300 Units/mL, TOUJEO® Max SoloStar® (insulin glargine injection) 300 Units/mL, LANTUS® (insulin glargine injection) 100 Units/mL, INSULIN GLARGINE injection 100 Units/mL (U-100) 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 $35 per 30 Day Supply. To pay $35 per 30 Day Supply, 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. 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 reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms of use at any time without notice. Upon registration, patients will receive all program details.

Sanofi US 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 healthcare program for purposes of the savings program. Void where prohibited by law.

  • Lantus or Insulin Glargine U-100 (Winthrop): Pay as low as $0 up to $99 for a 30-day supply. Amount depends on insurance coverage. Valid up to 10 packs per fill; offer valid for 1 fill every thirty days.

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.

Reference:
1. Lantus® Prescribing Information.
2. Rosenstock J, Davies M, Home PD, et al. Diabetologia. 2008;51:408-416.

All registered trademarks cited are property of their respective owners.