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Basal-Bolus Regimen

Proven glycemic efficacy with a simplified alternative to counting carbs1

In the Bergenstal et al study, Apidra® proved equally effective in a basal-prandial regimen with carb counting or a simplified algorithm1

BG reductions through week 24 (N=273)a

a At week 24, both groups reached the ADA and AACE goals for postprandial glucose at all time points measured.2,3

b Baseline postprandial blood glucose (BG) levels for simplified and carb-counting groups were: 212 and 191 mg/dL (postbreakfast), 203 and 185 mg/dL (postlunch), and 221 and 203 mg/dL (postdinner), respectively. 1

In a 24-week, controlled, open-label, randomized, parallel-group study of patients with type 2 diabetes not controlled on insulin therapy (≥2 injections per day), with or without metformin, for at least 3 months, patients were started on 1 injection of LANTUS® (insulin glargine [rDNA origin] injection) per day and Apidra® 3 times daily, using 2 different dosing algorithms to determine Apidra® dose.

From Bergenstal.1

 
 
  • A majority of patients in both groups achieved A1C <7.0% at endpoint: 73% with the simplified algorithm vs 69% with the carb-counting algorithm1
  • Mean fasting plasma glucose (FPG) was significantly reduced from baseline: 40-mg/dL reduction with the simplified algorithm vs 51-mg/dL reduction with the carb-counting algorithm1
  • Mean postprandial BG levels were reduced from baseline (postbreakfast, postlunch, and postdinner)1
    • Simplified algorithm: 79-, 75-, and 85-mg/dL reductions, respectively
    • Carb-counting algorithm: 63-, 56-, and 69-mg/dL reductions, respectively
  • Weight gain was not significantly different between the simplified (3.6 kg) and carb-counting (2.4 kg) groups1
Rates of AEs at 24 weeks

c Severe hypoglycemia was defined as requiring assistance and involved either self-monitored BG <36 mg/dL or treatment with oral carbohydrates, intravenous glucose, or glucagon, with a prompt response to that therapy. Data are based on numbers of patients from the safety population experiencing specified adverse events (AEs).

From Bergenstal.1

 
 
  • Hypoglycemic episodes reported as serious AEs: 2 events (simplified arm) and 7 events (carbohydrate-counting arm)4
  • AE possibly related to treatment, reported in more than 1 patient: hypoglycemia4

Apidra® is just as effective as RHI,5 but Apidra® has a 35-minute dosing window6

In the Dailey et al study, in patients with type 2 diabetes, A1C reductions and postprandial BG reductions were similar between groups5

Dailey et al study

A 26-week, randomized, open-label, active-control study compared Apidra® with regular human insulin (RHI) given premeal (both groups were given intermediate-acting basal insulin twice daily; mean baseline A1C of 7.6%). Endpoint was last available measurement after start of treatment. Apidra® or RHI was individually dosed, as appropriate, prior to at least 2 meals a day (breakfast and dinner).

From Dailey5 and data on file.4

 
 
  • A1C reductions from baseline were similar between both treatment groups: 0.46% reduction for Apidra® vs 0.30% reduction for RHI (P=0.0029)5
  • Postprandial BG values were similar between treatment groups at baseline5
  • Postprandial BG values were significantly lowered 2 hours postbreakfast and 2 hours postdinner in the Apidra® group5

    — BG values of Apidra® and RHI
    • Postbreakfast: 156 vs 162 mg/dL, respectively (P<0.05)
    • Postdinner: 154 vs 163 mg/dL, respectively (P<0.05)
  • The clinical relevance of the difference in A1C reductions between RHI and Apidra® is unknown5
  • Efficacy was maintained regardless of whether oral agents were used4
Rates of AEs at 26 weeks

d Severe symptomatic hypoglycemia was defined as symptomatic hypoglycemia requiring assistance from another person and confirmed by BG <36 mg/dL or associated with prompt recovery following oral carbohydrate, intravenous glucose, or glucagon administration.

From Dailey.5

 
 
  • A total of 65 patients experienced AEs possibly related to treatment: 41 patients (9.4%) in the Apidra® group and 24 patients (5.4%) in the RHI group. The most common AEs possibly related to treatment were peripheral edema (Apidra® 0.9%, RHI 0.2%) and weight increase (Apidra® 0.7%, RHI 0.5%).

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Important Safety Information for Apidra® (insulin glulisine [rDNA origin] injection)

CONTRAINDICATIONS

Apidra® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Apidra® or any of its excipients.

WARNINGS AND PRECAUTIONS

Closely monitor blood glucose in all patients treated with insulin. Change 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. As with all insulin preparations, the time course of Apidra® action may vary by individual or at different times in the same individual and is dependent on many conditions, including the site of injection, local blood supply, or local temperature.

Hypoglycemia is the most common adverse reaction of insulin therapy, including Apidra®, which may be serious.

Severe life-threatening, generalized allergy, including anaphylaxis, can occur. All insulins, including Apidra®, can cause hypokalemia, which if untreated, may be serious.

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

Apidra® for subcutaneous injection should not be mixed with insulins other than NPH. Do not mix Apidra® with any insulin when used in the pump or for intravenous administration. Insulin devices and needles must not be shared between patients.

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

Other adverse reactions commonly associated with Apidra® include injection site reactions, lipodystrophy, pruritus, and rash.

Important Safety Information for Apidra® (insulin glulisine [rDNA origin] injection) SoloSTAR®

Apidra® SoloSTAR® is a disposable prefilled insulin pen. To help ensure an accurate dose each time, patients should follow the steps in the Instruction Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin, which may affect their blood glucose.

Indications and Usage for Apidra® (insulin glulisine [rDNA origin] injection)

Apidra® is a rapid-acting insulin analog indicated to improve glycemic control in adults with type 2 diabetes or adults and children (4 years and older) with type 1 diabetes.

When used as a mealtime insulin, the dose of Apidra® should be given within 15 minutes before or within 20 minutes after starting a meal. Apidra® given by subcutaneous injection should normally be used in regimens that include a longer-acting insulin.

Please click here for Full Prescribing Information for Apidra®.

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

Monitor blood glucose in all patients treated with insulin. Insulin regimens should be modified 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. Insulin devices and needles must not be shared between patients.

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.

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

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

Other adverse reactions commonly associated with Lantus® are injection site reaction, lipodystrophy, pruritus, and rash.

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 children (6 years and older) 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.

Please click here for Full Prescribing Information for Lantus®

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*Offer is not valid for patients if their prescriptions are paid in part or full by any state or federally funded programs, including, but not limited to, Medicare or Medicaid, Medigap, VA, DOD, or TriCare. Offer is not valid for residents of MA (except for cash-paying patients) and where prohibited by law. Sanofi US reserves the right to rescind, revoke, or amend this offer without notice. Maximum benefit is $100 off per prescription depending on your out of pocket costs. Offer expires 12/31/2012.

References

  1. Bergenstal RM, Johnson M, Powers MA, et al. Diabetes Care. 2008;31(7):1305-1310.
  2. American Diabetes Association. Diabetes Care. 2010;33(suppl 1):S11-S61.
  3. AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. Endocr Pract. 2007;13(suppl 1):3-68.
  4. Data on file, sanofi-aventis U.S. LLC.
  5. Dailey G, Rosenstock J, Moses RG, Ways K. Diabetes Care. 2004;27(10):2363-2368.
  6. Apidra® Prescribing Information. February 2009.
     Last Update: November 2011


Prescription Apidra® is available in pharmacies.
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