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Efficacy and Safety

Apidra® Results in Clinical Studies

Learn how Apidra demonstrated A1C reduction and BG control in adults with type 2 diabetes mellitus in an OPAL (Orals Plus Apidra and Lantus® (insulin glargine injection) 100 Units/mL study, Apidra vs. RHI Study in Type 2 diabetes patients, and what results a PHILOTHEOU study showed in patients 4-17 years of age with type 1 diabetes mellitus.

A1C Reduction and Blood Glucose Control — OPAL STUDY

Efficacy: 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 (n=162 and n=152, respectively)
  • 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 (n=162) and main meal (n=152) 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 pre-lunch period1

Efficacy: 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 (n=162 and n=152, respectively)
  • 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
 
  • 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

 

Hypoglycemia is the most common adverse event associated with insulin-containing therapies.

aSevere 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

bP=NS.

cEvaluated for safety.

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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.

Limitations of Study

  • Although significantly more patients reached HbA1c target in the main meal group compared with the breakfast group, this should be interpreted with caution owing to the small numbers overall and within each treatment arm
  • Lack of a control arm in the study makes it difficult to assess the net effect of the addition of once-daily glulisine

T1DM PHILOTHEOU Study for Young Patients

Efficacy: Greater A1C Goal Achievement

In T1DM: Significantly more young patients (ages 4-17) achieved A1C goal vs. lispro‡ 2,3

  • Primary endpoint: baseline to endpoint mean A1C changes were similar between groups (Apidra 0.1%; lispro 0.2%)2

eFor all age groups together, the percentage of subjects achieving the ADA-recommended A1C target (7.5%-8.5% for children less than 6 years old, <8% for children 6-12 years old, and <7.5% for children/adolescents over 12 years of age).4

ADA target has changed for toddlers and preschoolers (0-6) to A1C <7.5%.4

‡For the purpose of this trial, references to lispro refer to Humalog® (insulin lispro).

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Philotheou study: A 26-week, open-label, active-control, noninferiority study to compare the efficacy and safety of Apidra (n=277) with lispro‡ (n=295) added to Lantus or NPH in a basal-bolus regimen. Subjects with T1DM (ages 4-17) were randomized to receive Apidra or lispro 0-15 minutes premeal. Primary endpoint was mean change in A1C from baseline to endpoint.1,2

Limitations of Study

  • Changes in insulin doses were not adjusted for sex, age, or pubertal status, which are factors known to affect insulin requirements because of differences in metabolic requirements
  • Patients were using one of two different basal insulins (NPH or glargine), which may limit extrapolation of the results

Safety Results

T1DM, type 1 diabetes mellitus

Hypoglycemia is the most common adverse event associated with insulin-containing therapies.

A1C Reduction in Type 2 Diabetes

   

a Last available measure after start of treatment.

n=876 (Apidra: n=435; RHI: n=441)

A1C was significantly reduced with Apidra in patients with type 2 diabetes5,2

  • All efficacy variables were determined using the intent-to-treat population5
  • Statistically significant reductions from baseline observed with glulisine (-0.46%) versus RHI (-0.30%) from 12 weeks onwards (P<0.05)5
  • The clinical relevance of the difference in A1C reductions between RHI and Apidra is unknown

Safety Results

   

Hypoglycemia is the most common adverse event associated with insulin-containing therapies.

b 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. All severe hypoglycemia episodes are considered as serious adverse events.5

c P=NS.

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A 26-week, randomized, open-label, active-control, study compared Apidra with RHI given premeal in 876 type 2 diabetes patients, 30 to 80 years old, with BMI <45 kg/m2 and A1C >7.5%. Both groups were given intermediate-acting basal insulin twice daily; mean baseline A1C of 7.6%. Subjects continued the same dose of prestudy OAD regimen unless hypoglycemia necessitated changes. The treatment consisted of 2 injections of Apidra or 2 injections of RHI in addition to 2 injections of NPH. More than 2 injections of RHI or Apidra were permitted as per investigators’ judgment. Apidra or RHI was individually dosed as appropriate, prior to at least 2 meals a day (breakfast and dinner). Endpoint was last available measurement after start of treatment.5

Limitations of Study

  • Certain aspects of the study design may have contributed to the observed between-treatment difference in baseline to end point change in HbA1c
  • This type of open-label design has been a necessity with any study comparing a rapidacting insulin analog with RHI due to considerable differences in the timing of the administration of these two types of insulin
  • The large sample size of the study may also account for a determination of statistical significance for a difference that is of unclear clinical relevance at this time
   

NOS=not otherwise specified.

Hypoglycemia is the most common adverse event associated with insulin-containing therapies.

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About Apidra

Learn how rapid-acting Apidra works to mimic the secretion pattern of endogenous human insulin.

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Dosing

Get information about how to initiate and dose Apidra using the AACE Algorithm.

LEARN ABOUT AACE ALGORITHM

See Savings Offers

Apidra offers options for patients with and without prescription insurance. Eligibility and restrictions apply*.

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Indications and Usage for Apidra® (insulin glulisine injection)

Apidra is a rapid-acting insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

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 may be infused subcutaneously by external insulin infusion pumps.

Important Safety Information

Contraindications

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

Warnings and Precautions

Insulin pens and needles must never be shared between patients, even if the needle is changed. Do NOT reuse needles.

Monitor blood glucose in all patients treated with insulin. Modify insulin regimens 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. Dosing should be individualized based on patient characteristics and lifestyle.

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.

Hypoglycemia is the most common adverse reaction associated with insulins, including Apidra, and maybe life-threatening.

To avoid medication errors between APIDRA and other insulins, instruct patients to always check the insulin label before each injection.

All insulin products, including Apidra, can cause hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia.

Severe life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including APIDRA. If hypersensitivity reactions occur, discontinue APIDRA, treat per standard of care and monitor until symptoms and signs resolve.

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.

Malfunction of the insulin pump or insulin infusion set or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Patients using insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

Adverse Reactions

Adverse reactions commonly associated with Apidra include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, and weight gain.

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).

Important Safety Information for Apidra® (insulin glulisine injection) SoloSTAR®

Apidra SoloSTAR is a disposable single-patient-use 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.

Important Safety Information for Apidra Use in Pump

Inform patients to replace the infusion sets (reservoir, tubing, and catheter) and the Apidra in the reservoir at least every 48 hours and select a new infusion site. Pump failure or insulin infusion set or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Prompt identification and correction of the cause is necessary. Interim subcutaneous injections with APIDRA may be required. Patients using a pump must be trained to administer insulin by injection and have alternative insulin therapy available in case of pump system failure.

Click here for Full Prescribing Information for Apidra.
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*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 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.

  • Apidra: $0 copay with maximum savings up to $100 per pack up to 1 pack per fill.

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.

REFERENCES:

  1. Sheldon B, Russel-Jones D, Wright J. Diabetes Obes Metab. 2009;11:5-9.
  2. Becker RHA, Frick AD, Burger F, Potgieter JH, Scholtz H. Exp Clin Endocrinol Diabetes. 2005;13:435-443.
  3. Bolli GB, Luzio S, Marzotti S, et al. Diabetes Obes Metab. 2011;13:251-257.
  4. Heise T, Nosek L, Spitzer H, et al. Diabetes Obes Metab. 2007;9:746-753.
  5. Apidra® Prescribing Information.
  6. NovoLog® Prescribing Information.
  7. Humalog® Prescribing Information.

All registered trademarks cited are the property of their respective owners.

REFERENCES:

†Humalog® savings card information. Available at: https://www.humalog.com/hcp/humalog-u200/#savings-card-section.
NovoLog® savings card information. Available at: https://www.novologpro.com/savings-and-coverage.html.

‡Relay: Data Months: September 2016 – August 2017.

All registered trademarks cited are the property of their respective owners.

REFERENCES:

  1. AACE/ACE Consensus Statement. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2016 Executive Summary. T2D Algorithm, Executive Summary. Endocr Pract. 2016;22(No.1).
  2. Apidra® Prescribing Information.
  3. NovoLog® Prescribing Information.
  4. Humalog® Prescribing Information.

All registered trademarks cited are the property of their respective owners.

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

Indication and Use

Lantus is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

Limitations of Use

Lantus is not recommended for the treatment of diabetic ketoacidosis.

Important Safety Information

Contraindications

Lantus is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine or any of the excipients in LANTUS.

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 drugs.

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.

Hypoglycemia due to 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 & Offer Terms:

Insulins Valyou Savings Program: This savings program is not insurance. For a complete list of participating brands, products, and National Drug Codes (NDCs) Click Here. This offer is not valid for prescriptions covered by or submitted for reimbursement, in whole or in part, under Medicare, Medicaid, VA, DOD, TRICARE, similar federal or state programs, including any state pharmaceutical programs, or commercial/private insurance. Only patients without prescription medication insurance can apply for this offer. Void where prohibited by law. For the duration of the program, eligible cash paying 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. 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. For questions regarding your eligibility or benefits, or if you wish to discontinue your participation, call the Insulins Valyou Savings Program at (833) 813-0190 (8:00 am-8:00 pm EST, Monday-Friday).

Sanofi Insulins Co-pay Savings Program: This savings program is not insurance. For a complete list of participating brands, products, and National Drug Codes (NDCs) Click Here. This offer is not valid for prescriptions covered by or submitted for reimbursement, in whole or in part, under Medicare, Medicaid, VA, DOD, TRICARE, similar federal or state programs, including any state pharmaceutical programs. 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 health care program for purposes of the savings program. Void where prohibited by law. For the duration of the program, eligible commercially insured patients pay no more than $35 per 30-day supply, up to 10 packs per fill; Offer valid for one fill every 30 days. Savings may vary depending on patients’ out-of-pocket costs. The Sanofi Insulins Co-pay 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. For questions regarding your eligibility or benefits, or if you wish to discontinue your participation, call the Sanofi Insulins Co-pay Savings Program at (866) 255-8661 (8:00 am-8:00 pm EST, Monday-Friday).

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.
  3. Philotheou A, Arslanian S, Blatniczky L, Peterkova V, Souhami E, Danne T. Diabetes Technol Ther. 2011;13(3):327-334.
  4. American Diabetes Association. Diabetes Care. 2015;38(Suppl. 1):S70–S76.
  5. Daily G, et al. Diabetes Care. 2004;27:2363-2368.

All registered trademarks cited are the property of their respective owners.

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Important Safety Information

Contraindications

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

Warnings and Precautions

Insulin pens and needles must never be shared between patients, even if the needle is changed. Do NOT reuse needles.

Monitor blood glucose in all patients treated with insulin. Modify insulin regimens cautiously and only under medical supervision.