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Important Safety Information for Lantus® (insulin glargine [rDNA origin] injection)

Contraindications: Lantus® is contraindicated in patients hypersensitive to insulin glargine or one of its excipients.

Click here for additional Important Safety Information.

In Insulin-naïve Adults With Type 2 Diabetes

Significant A1C reductions1

Study Design

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

Reductions in A1C

From Rosenstock.1

  • A1C decreased by 1.5% with both insulins and was comparable after 52 weeks (7.1% for Lantus® and 7.2% for detemir
  • Overall, 52% of participants achieved A1C ≤7%; 33% (detemir) and 35% (Lantus®) without hypoglycemia

100% of Lantus® patients dosed QD throughout the study

Mean Daily Dose

  • Mean daily dose after 52 weeks (U/kg): detemir twice daily 1.00, detemir once daily 0.52, Lantus® 0.44
  • Incidence of major hypoglycemia: Lantus® 3%, detemir 2%
  • Overall rate of hypoglycemia (events per patient-year): 6.2 Lantus®, 5.8 detemir; P=NS

Safety Results

Safety Results chart

  • Individuals treated with BID detemir had weight gain similar to those treated with QD Lantus®

Proven HbA1c control

See how Lantus® provides effective, improved glycemic control in diabetes patients.

Lantus® Prescribing Information. February 2015.

Once-daily dosing

Lantus® is a once-daily, long-acting insulin.**

**Lantus® Prescribing Information. February 2015.

Demonstrated long-term CV safety

Lantus® is a basal insulin with demonstrated long-term CV safety data††

††Including CV death, nonfatal MI, nonfatal stroke, revascularization, or hospitalization for heart failure. No difference was observed between Lantus® and standard of care in overall incidence of CV death, nonfatal MI, or nonfatal stroke. No difference was observed between treatment groups for death of any cause.

Indications and Usage for Lantus® (insulin glargine [rDNA origin] injection)

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.

Important Limitations of Use: Lantus® is not recommended for the treatment of diabetic ketoacidosis. Use intravenous short-acting insulin instead.

Important Safety Information for Lantus® (insulin glargine [rDNA origin] injection)

Contraindications

Lantus® is contraindicated 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 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.

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.

Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Lantus®, monitor and treat if indicated.

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

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 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.

Full Prescribing Information for Lantus®
Sanofi's Commitment to Fighting Counterfeit Drugs

References:

  1. Rosenstock J, Davies M, Home PD, et al. Diabetologia. 2008;51:408-416.

Indications and Usage for Lantus® (insulin glargine [rDNA origin] injection)

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.

Important Limitations of Use: Lantus® is not recommended for the treatment of diabetic ketoacidosis. Use intravenous short-acting insulin instead.

Important Safety Information for Lantus® (insulin glargine [rDNA origin] injection)

Contraindications

Lantus® is contraindicated 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 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.

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.

Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Lantus®, monitor and treat if indicated.

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

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 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.

Full Prescribing Information for Lantus®
Sanofi's Commitment to Fighting Counterfeit Drugs

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