Sanofi Diabetes
YOU ARE HERE
Apidra®
For U.S. Healthcare Professionals Only
Help your patients save on Apidra® through our Mealtime Masters Program! Learn more >>

Increased A1C and BG Control

In the OPAL study, the Apidra® Basal-Plus 1 regimen helped patients reach A1C goal1

  • The adjusted mean baseline to endpoint changes in A1C were comparable between the breakfast (−0.31%) and main mealtime (−0.36%) glulisine injection groups
  • Treatment equivalence of both breakfast and main meal Apidra® regimens was demonstrated
  • Adding 1 dose of Apidra® a day to Lantus® (insulin glargine injection) and OADs resulted in significant A1C reductions from baseline to endpoint: breakfast group, from 7.35% to 7.03%; main meal group, from 7.29% to 6.94%1

Improvements in BG control were significant in both breakfast and main meal groups1

Improved 8-pt BG profiles for breakfast and main meal groupsa

  • Significant PPG reductions from baseline to endpoint were recorded as follows: breakfast group, from 172.6 mg/dL to 137.3 mg/dL; main meal group, from 187.9 mg/dL to 153.1 mg/dL (P<0.0001 for both groups)1
  • In the breakfast arm, improved BG levels also extended to the prelunch period1
  • In a subgroup of patients with baseline A1C >7%, Apidra® Basal-Plus 1 at the main meal helped more than 50% of patients achieve A1C ≤7%1

Safety Results

a Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia during which the person required the assistance of another person which was associated with blood glucose level below 36 mg/dL (2.0 mmol/l) and/or an administration of oral carbohydrate, intravenous glucose or glucagons.2
b P=NS.
c Evaluated for safety.

Study Design1,2

SMBG, self-monitored blood glucose.
a Per-protocol treatment group.
b Individually determined by the median of mealtime-specific 2-h postprandial BG values after breakfast, lunch, and dinner on 3 different days, determined by 6-pt. SMBG. Main meal was defined as the maximum of the 3 medians.

24-week, multicenter, parallel, open-label, 1:1 randomized study comparing the efficacy of Apidra® administered at breakfast or the main meal in 316 patients ≥18 years with type 2 diabetes who were previously uncontrolled on Lantus® (insulin glargine injection) and OADs and whose A1C was >6.5% and <9%. At the end of the screening phase, 316 patients with FBG ≤120mg/dL were randomized and administered 1 injection of Apidra® at either breakfast (n=162) or main mealtime (n=154). The dosage was individually titrated at the investigator’s discretion to the target goals of 2h PPG ≤135 mg/dL and FBG ≤100 mg/dL in the absence of hypoglycemia.

OPAL, Orals Plus Apidra® and Lantus®.

Next Page

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.

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

Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles.

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.

Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs) with insulin. Observe for signs and symptoms of heart failure. Consider dosage reduction or discontinuation of TZD if heart failure occurs.

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.

Please click here for Full Prescribing Information for Apidra®.

Indications and Usage for Lantus® (insulin glargine injection) 100 Units/mL

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® (insulin glargine injection) 100 Units/mL

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 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.

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 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.

Please 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.

*Certain restrictions apply for the savings program. This offer is not valid for prescriptions covered by or submitted for reimbursement under Medicare, Medicaid, VA, DOD, or TRICARE, or similar federal or state programs including any state medical pharmaceutical programs. Void where prohibited by law. The maximum savings is $100 off per monthly prescription for the duration of the program. Savings may vary depending on patient’s out-of-pocket costs. Upon registration, patient receives all program details. Sanofi US reserves the right to rescind, revoke, or amend the program without notice. As of September 2017.

Humalog savings card information. Available at: https://www.humalog.com/hcp/humalog-u200.aspx#savings-card-section. Accessed September 6, 2017.

NovoLog savings card information. Available at: https://www.novologpro.com/prescribing/prescription-savings.html . Accessed September 6, 2017.

References

  1. Lankisch MR, Ferlinz KC, Leahy JL, Scherbaum WA. Orals Plus Apidra® and Lantus® (OPAL) study group. Diabetes Obes Metab. 2008;10(12):1178-1185.
  2. Apidra Prescribing Information. February 2015.

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.

Important Safety Information for Apidra®

Contraindications

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

Warnings and Precautions

Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles.

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.

Click here for additional Important Safety Information.

Click here for full prescribing information for Apidra®.

Flash Player
Flash Player

You need a Flash Player in order to view some content. You are about to be directed to Macromedia Flash Player Download Center.

Click the CONTINUE button below to go to the Macromedia Flash Player Download Center, or the CANCEL button to return to the previous page.

NOTE: After installation is complete, please restart your browser.

Cancel
Continue
Flash Player