Insulin Aspart - Uses, Dosage, Precautions, and Side Effects

Overview:

Insulin Aspart is a modified or rapid-acting human insulin for managing type 1 and type 2 diabetes mellitus. The drug is usually injected subcutaneously in children and adults. However, it can also be given intravenously. The drug produces its maximum effect within one to three hours, lasting for three to five hours. It is a biological drug that does not have any biosimilars currently. A biological drug is usually made from living cells, whereas a non-biological drug comprises generic versions. The drug comes as a solution and is mealtime or rapid-acting Insulin. Insulin Aspart is manufactured using yeast, whose genome comprises the gene for Insulin Aspart. Hence, the gene present in the yeast synthesizes Insulin. Finally, this Insulin is harvested with the help of a bioreactor.

Insulin Aspart Development History:

• The discovery of Insulin was an important milestone in the history of medical science. Insulin has marked a revolution in the prognosis and management of diabetes.

• Insulin Aspart is an analog or a genetically modified version of Insulin that was approved and released in the year 2000.

• Insulin Aspart is similar to the Insulin used daily, the only difference being a single substitution of amino acid proline by the other amino acid named aspartic acid on position B28. The drug is mainly obtained using recombinant DNA (deoxyribonucleic acid) technology which uses Saccharomyces cerevisiae as the source organism.

• Finally, Insulin Aspart was launched in the market by a Denmark-based company named NovoNordisk in the United States (US).

• The drug was approved by the US FDA (Food and Drug Administration) on September 29th, 2017.

How Does Insulin Aspart Work to Treat Type 1 and Type 2 Diabetes?

Insulin Aspart is a human insulin analog that works by regulating glucose metabolism. In addition, the drug promotes storage and does not allow the breakdown of fats, glucose, and amino acids into simpler substances. Insulin promotes peripheral glucose utilization, thereby lowering blood glucose levels. It transports the body's glucose to skeletal muscles ensuring its proper utilization. In addition, Insulin Aspart inhibits the hepatic production of glucose, lipolysis (breakdown of fats or lipids to fatty acids), and proteolysis (conversion or breakdown of fats into amino acids) so that the body's glucose levels remain within limits. The glucose-lowering effects of the drug are noticeable within one to two hours and persist for three to five hours. Insulin Aspart, a novel synthetic analog of Insulin, demonstrates a faster onset and a shorter course of action. Hence, Insulin Aspart is preferred over Insulin because it can be given every four hours.

Insulin Aspart Sliding Scale:

A sliding scale is a chart comprising information about Insulin's dosing range for each meal. The dosage range is based on the person's sugar level. Doctors usually recommend a sliding scale for patients so that they take the correct dose of the drug. In addition, they also recommend a dosing range on the sliding scale as per the patient's diet, exercise, and medications taken by him. The patient can discuss this with the doctor to know more about the sliding scale. The following factors affect the Insulin Aspart dosage:

• The type of condition for which Insulin Aspart is being used.

• Patient's age.

• Diet.

• Weight.

• The number of times the patient exercises during the day.

• Medications consumed by the patient.

• Body's response to Insulin.

• Other medical conditions.

Insulin Aspart and Insulin Lispro - Are They Similar?

Insulin aApart and Insulin lispro are rapid-acting Insulins used to manage patients with type 1 and type 2 diabetes mellitus. However, it has been noticed that Insulin Aspart works faster than Insulin lispro. Therefore, although both drugs belong to the same class, they cannot be taken interchangeably. However, patients willing to dosage conversion between the two must consult their doctor. This is because the dosage conversion depends upon several factors and needs to be decided only by the doctor. In addition, some patients might notice fluctuations in their blood sugar levels if they wish for dosage conversion.

What Are the Medical Uses of Insulin Aspart?

Insulin Aspart is used in adults and children to establish control over diabetes mellitus. The medical uses of Insulin Aspart are listed below:

• Type 1 diabetes.

• Type 2 diabetes.

• Hyperkalemia (elevated potassium levels).

• Autoimmune diseases.

• Diabetic coma.

• Diabetes ketoacidosis (a life-threatening condition in which the body breaks down fats at a faster rate).

Dosage and Administration:

Important Instructions for Drug Administration:

• The patient must carefully check Insulin levels before administering the drug.

• Inspect the drug visually before taking it.

• Insulin Aspart is a colorless and odorless solution. So, avoid using it if the solution is filled with particulate matter.

• Avoid mixing Insulin Aspart with other Insulin solutions when administered using a continuous or a subcutaneous infusion pump.

Route of Administration of Insulin Aspart:

1) Subcutaneous Injection:

• Insulin Aspart is usually administered subcutaneously five to ten minutes before a meal into the thighs, buttocks, or abdominal region.

• The injection sites must be rotated from one site to the other to avoid the risk of lipodystrophy.

• When Insulin Aspart injection is administered subcutaneously, it can be used along with intermediate or long-acting Insulins.

• Insulin Aspart can also be diluted using Insulin Diluting Medium if it is to be used subcutaneously. When one part of Insulin Aspart is diluted with nine parts of the diluent, it yields a concentration of one-tenth of Insulin Aspart.

2) Continuous Subcutaneous Infusion or Insulin Pump:

• Patients using a continuous subcutaneous infusion pump must be trained to administer Insulin. These patients should also be advised to have an alternative Insulin therapy in the case of pump failure.

• The drug must be administered by continuous subcutaneous infusion in the tissues of the abdominal wall.

• Consult a doctor to learn about the basal and mealtime infusion rate.

• Insulin Aspart must be changed in the reservoir every six days.

• The infusion set and its insertion site must be changed every three days.

• Insulin Aspart in the pump reservoir must not be kept in temperatures above 98.6 degrees Fahrenheit.

• Read the information in the patient's manual carefully to avoid mistakes while administering the drug.

3) Intravenous Administration:

• Insulin Aspart can be diluted to concentrations from 0.05 units per mL to 1 unit per mL using polypropylene infusion bags. The drug is usually stable in infusion fluids such as 0.9 % sodium chloride.

• The drug must be administered intravenously only under a doctor's supervision, along with close monitoring of glucose and potassium levels.

Information Related to the Dosage:

• The dosage of Insulin Aspart must be adjusted based on the route of administration, blood glucose monitoring results, metabolic needs of an individual, and glycemic control.

• Insulin Aspart's dosage can be adjusted as per physical activities, meal patterns, and changes in the kidney or liver functions.

Instructions for Mixing Insulin Aspart With Other Insulin Preparations:

The table below describes whether other Insulin preparations can be mixed with Insulin Aspart:

Dosage Forms and Strengths:

Insulin Aspart 100 units per mL is a clear or colorless solution available for injection in the following vials:

• 10 mL vials.

• 3 mL Insulin Aspart FlexPen.

• 3 mL Insulin Aspart FlexTouch.

• 3 mL PenFill cartridges.

General Information About Type 1 and Type 2 Diabetes:

What Is Type 1 Diabetes?

Type 1 diabetes, juvenile diabetes, or insulin-independent diabetes mellitus is a long-standing condition wherein the pancreas produces little insulin. It can affect people of any age group. Insulin is a hormone that promotes the utilization of glucose by the body. Due to insulin deficiency, glucose accumulates in the bloodstream resulting in a condition known as diabetes. Type 1 diabetes is less frequently observed than type 2 diabetes. Hence, only five to ten percent of people get affected by type 1 diabetes. There is no definite cure for diabetes, so the treatment is only directed toward managing blood sugar levels.

What Is Type 2 Diabetes?

Type 2 diabetes is a condition wherein the way the body uses glucose as an energy source gets impaired. It is a chronic condition wherein excessive glucose circulates in the bloodstream. Hence, excessive blood sugar levels can cause nervous, circulatory, and immune disorders. Type 2 diabetes is associated with two major problems, including insufficient production of insulin by the pancreas and the poor response of cells to insulin. Type 2 diabetes is more commonly observed in adults and children with obesity. There is no permanent cure for this condition, but a proper diet and exercise can help prevent this condition.

For Patients:

What Is Insulin Aspart?

Insulin Aspart is a manmade insulin used to maintain blood sugar levels in adults and children within normal limits. The patient must avoid sharing Insulin Aspart FlexPen, Flex Touch, or PenFill cartridges with others, even if using a different needle. This is because a patient might have a serious infection. In addition, patients must avoid taking Insulin Aspart if they have an episode of hypoglycemia or low blood sugar levels or are allergic to any of the ingredients of the drug.

What Should the Patient Inform the Doctor Before Taking Insulin Aspart?

Before taking Insulin Aspart, the patient must inform the doctor if he or she:

• Is allergic to the ingredients of Insulin Aspart or other medications.

• Is taking or planning to consume any of the following drugs:

  • Albuterol.

  • Benazepril.

  • Captopril.

  • Enalapril.

  • Candesartan.

  • Azilsartan.

  • Olanzapine.

  • Atenolol.

  • Labetalol.

  • Diuretics.

  • Clonidine.

  • Indinavir.

  • Aspirin.

  • Terbutaline.

• Has experienced nerve damage, cardiac diseases, or liver problems due to diabetes.

• Is pregnant, breastfeeding, or planning to do the same in the future.

• Is planning to undergo surgery, including dental surgery.

• Is an alcoholic. This is because alcohol can alter the drug's actions.

Note -

• The patient must avoid driving or operating heavy machinery after taking the drug.

• The patient must inform the doctor if one experiences unusual symptoms, sickness, or stress.

• Consult the doctor to know how often the glucose levels must be checked.

How Should the Patient Take Insulin Aspart?

1. The patient must carefully read the "Instructions for Use" that is provided with Insulin Aspart.

2. Take the drug exactly as told by the doctor.

3. Insulin Aspart is a rapid-acting drug. Hence, the patient must eat something within five to ten minutes of taking the drug.

4. Keep the strength and dosage of the drug in mind. Do not change the drug dose immediately.

5. The patient's blood sugar levels must be constantly monitored during the therapy.

6. Avoid reusing or sharing needles with others to avoid the risk of transmission of infections.

Safety and Effectiveness of Insulin Aspart:

A particular medication might be prescribed for purposes other than those mentioned in the patient information leaflet. The patient can ask the pharmacist or doctor for more information about the drug. Do not use Insulin Aspart for a condition that was not recommended. Avoid administering the drug to other people even if they present with similar symptoms.

What Are Some of the Side Effects of Insulin Aspart?

Some of the serious side effects of Insulin Aspart are listed below:

• Low blood sugar or hypoglycemia.

• Dizziness.

• Blurred vision.

• Lightheadedness.

• Sweating.

• Confusion.

• Anxiety.

• Irritability.

• Mood swings.

• Slurred speech.

• Hunger.

• Tremors.

• Headache.

• Irregular heartbeat.

The patient might require a dose change in the following situations:

• Increased stress or anxiety.

• Dietary modifications.

• Changes in the levels of physical activities.

• Weight loss or gain.

• Illness.

Some of the other common side effects of Insulin Aspart are listed below:

1. Low potassium levels in blood or hypokalemia.

2. Allergic reactions at the injection side.

3. Rashes.

4. Itching.

5. Lipodystrophy.

6. Weight gain.

7. Swelling of the hands and feet.

The patient must seek emergency medical attention under the following situations:

• Respiratory difficulties.

• Shortness of breath.

• Elevated heart rate.

• Swelling of the throat, tongue, or face.

• Drowsiness.

• Confusion.

• Dizziness.

• Sweating.

For Doctors:

Description:

Insulin Aspart injection is a fast-acting human insulin analog used for controlling blood sugar levels in adults and children. The only difference between Insulin Aspart and human Insulin is that position B28 is occupied by the amino acid, aspartic acid, instead of proline. The drug is produced using the recombinant DNA (deoxyribonucleic acid) technology from a fungus. The empirical formula of Insulin Aspart is C256H381N65079S6, and the molecular weight of the drug is 5825.8. The drug is a sterile, colorless, clear, and aqueous solution with a pH in the range of 7.2 to 7.6. Sometimes, hydrochloric acid 10 % or sodium hydroxide ten percent can be added to the drug to adjust its pH (potential of hydrogen).

Indications and Usage:

Insulin Aspart is similar to human Insulin and is prescribed to improve glycemic control in children and adults diagnosed with type 1 or type 2 diabetes mellitus.

Contraindications:

Insulin Aspart is contraindicated in episodes of hypoglycemia and patients who are sensitive to the ingredients of the drug.

Clinical Pharmacology:

Mechanism of Action:

Both human Insulin and Insulin Aspart primarily target the glucose levels of the body. They work by regulating the metabolism of glucose. Insulin Aspart lowers blood glucose levels by promoting peripheral glucose uptake and utilization, specifically by skeletal muscles and fat. In addition, the drug inhibits glucose production by the liver and lipolysis. Also, Insulin Aspart enhances the synthesis of proteins.

Pharmacodynamics:

Subcutaneous Administration:

The maximum glucose-lowering effect of Insulin Aspart was observed between one to three hours of subcutaneous administration. The duration of action of the drug is three to five hours. However, the time of onset and action of human Insulin and Insulin Aspart varies in different individuals.

Intravenous Administration:

A double-blind, randomized trial was done on 16 patients with type 1 diabetes mellitus. Intravenous administration of Insulin Aspart in those patients demonstrated that the blood glucose profile was similar to that after intravenous infusion of regular human Insulin.

Pharmacokinetics:

Subcutaneous Administration:

Absorption and Bioavailability:

A comparative study was conducted on 107 healthy patients and 40 patients with type 1 diabetes mellitus. The median time to the maximum concentration of the drug during this trial was 40 to 45 minutes versus 80 to 120 minutes. The trial results demonstrated that both Insulin Aspart and human Insulin were absorbed at similar rates.

Distribution:

The binding affinity of Insulin Aspart to plasma proteins is less than 10 %.

Metabolism and Elimination:

A randomized, double-blind crossover study done on 17 healthy patients revealed that the mean Insulin clearance rate was 1.2 L/h/kg for both human Insulin and Insulin Aspart.

Chemical Taxonomy:

Nonclinical Toxicology:

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

No animal studies have been performed to evaluate the carcinogenic potential of Insulin Aspart. However, a study was done on rats for 52 weeks who were administered Insulin Aspart at a dose 32 times the human dose. The study revealed that the female rats developed mammary gland tumors. In addition, Insulin Aspart was found to be genotoxic in the following tests:

• Ames test.

• Mouse lymphoma cell forward gene mutation test.

• Human peripheral blood lymphocyte chromosome aberration test.

• In vivo micronucleus test in mice.

• Ex vivo test in rat liver hepatocytes.

No adverse effects related to fertility were observed when Insulin Aspart was administered at 32 times the human dose in rats.

Warnings and Precautions:

• Hyperglycemia or Hypoglycemia - People taking the drug might have a risk of developing hypoglycemia because of the change in Insulin strength, manufacturer, method, or the type of administration. Hence, any change related to the drug must be made cautiously and under medical supervision. In addition, the frequency of blood glucose monitoring must also be carefully monitored. Patients diagnosed with type 2 diabetes might need dosage adjustment of concomitant anti-diabetic products.

• Hypoglycemia - It is one of the most common side effects of most Insulin therapies. Patients with severe hypoglycemia tend to have seizures or unconsciousness. It can also impair a patient's concentration and reaction time. Hypoglycemia can occur suddenly, and an individual may experience changes in the symptoms over time.

  • Risk Factors for Hypoglycemia - Patients taking Insulin injections are at a higher risk of developing hypoglycemia when the glucose-lowering effect of the drug is at its peak. The glucose-lowering time of different insulin preparations varies according to the individual's response. In addition, it also depends upon the site of injection, blood supply, and temperature. Some of the other factors that increase the risk of hypoglycemia are listed below:

    • Changes in meal pattern.

    • Changes in physical activities of a person.

    • Changes in concomitantly administered medications.

    • Patients with hepatic or renal problems.

• Hypoglycemia Due to Other Causes - Hypoglycemia can occur not only due to the drug's effects but also due to the accidental mix-up of other insulin preparations. The patient must always check the drug label carefully to avoid medication errors.

• Hypersensitivity or Allergic Reactions - Insulin Aspart can cause severe allergic reactions, including anaphylaxis. The patient can discontinue the drug if hypersensitivity reactions are suspected.

• Hypokalemia - It has been observed that insulin products, including Insulin Aspart, can shift the potassium from the extracellular to the intracellular spaces, resulting in a condition known as hypokalemia. If hypokalemia is left untreated for a long time, the patient might develop respiratory paralysis, death, and ventricular arrhythmia. Hence, the patient's potassium levels must be carefully monitored.

• Risk of Fluid Retention and Heart Failure With Proliferator-Activated Receptor (PPAR) Gamma Agonists - Thiazolidinediones are the commonly used PPARs that can causedose-related fluid accumulation or retention if used in combination with Insulin Aspart. As a result, the patient might experience heart failure. Hence, such patients must be carefully evaluated for the signs and symptoms of cardiac arrest. In case of heart failure, the patient must be managed according to the guidelines and should be advised of dose discontinuation or reduction.

• Hyperglycemia and Ketoacidosis - Hyperglycemia and ketoacidosis can occur due to the failure of an insulin pump or insulin infusion set. Hence, it is important to identify the causes of hyperglycemia or ketosis.

What Are the Adverse Reactions of Insulin Aspart?

Some of the following common adverse reactions were observed in more than five percent of the patients with type 1 diabetes mellitus:

• Headache.

• Accidental injuries.

• Diarrhea.

• Nausea.

Some of the following common adverse reactions were observed in more than five percent of the patients with type 2 diabetes mellitus:

• Hyporeflexia.

• Onychomycosis.

• Sensory disturbances.

• Urinary tract infections.

• Chest pain.

• Headache.

• Skin disorders.

• Abdominal pain.

• Sinusitis.

• Erythema.

• Local edema.

• Rashes.

• Pruritus.

• Reversible ophthalmologic refraction disorder.

• Peripheral neuropathy.

• Lipodystrophy.

• Lipohypertrophy.

• Weight gain.

• Peripheral edema.

Immunogenicity:

There is a potential for immunogenicity with all therapeutic proteins. The presence of antibodies depends on the specificity and sensitivity of the assay. The following factors influence the presence of antibodies in an assay:

• Assay methodology.

• Sample handling.

• Timing of sample.

• Collection.

• Concomitant medications.

• Underlying diseases.

Instructions for Use - Insulin Aspart Pen:

• The patient must not share the Insulin Aspart injection with others even after changing the needle to avoid the risk of transmission of infections.

• Insulin Aspart pen contains 300 units of U-100 Insulin. The patient can inject 1 to 80 units in a single injection.

• The pen is not recommended for use by visually impaired patients without medical supervision.

• The patient will require the following to give the Insulin Aspart injection:

  • Insulin Aspart pen.

  • Alcohol swab.

  • A new needle.

  • A container is used for throwing the pens and needles.

Preparing the Insulin Aspart Touch pen:

• The patient must wash his hands with soap and water.

• Before preparing the injection, check the label on the Insulin Aspart pen to ensure that the right type of Insulin is being taken.

• Insulin Aspart solution must be colorless and clear. Do not use the solution if it appears thick, colored, or cloudy.

• Do not use the drug beyond the expiration date.

• Always insert a new needle for every injection to ensure sterility.

Step 1: Remove the pen cap straight off.

Step 2: Check whether the liquid in the pen appears colorless and clear.

Step 3: Remove the paper tab from the outer needle cap. Make sure that every time a new needle is selected.

Step 4: Push the needle along with its cap into the pen and twist it until it becomes tight.

Step 5: Remove the outer cap from the needle, but do not dispose of it.

Step 6: Remove the inner cap of the needle and discard it.

Step 7: Switch the dose selector to two units.

Step 8: Hold the pen upright with the tip pointing upwards. Gently tap the top of the pen a few times to prevent the formation of air bubbles.

Step 9: Hold the pen upright and press the dose button until the dose counter shows zero. A drop of Insulin is seen at the tip of the needle.

Step 10: Turn the dose selector to select the units of Insulin to be injected. If a wrong dose is selected, the dose selector can be turned forward or backward to adjust the dose. Usually, even numbers are printed on the dial of the dose selector, whereas odd numbers appear as lines.

Giving the Injection:

• Inject the dose as instructed by the doctor.

• The doctor must instruct the patient to pinch the skin before giving the drug.

• Insulin Aspart is usually injected under the skin, thighs, buttocks, abdomen, and upper arm.

• Avoid using the same injection site for each injection.

Step 11: Choose the correct injection site and wipe it with an alcohol swab. Allow the site to dry before injecting.

Step 12: Insert the needle into the skin, but make sure that the dose counter is visible. Do not cover it with your fingers because this can stop the injection.

Step 13: Push the dose counter button down until it shows zero. Keep the needle in the skin and count from one to six. If the needle is removed before counting six, the patient might see an insulin stream oozing from the needle tip.

Step 14: Pull out the needle from the skin. If blood is visible at the site of injection, press the injection site with the help of an alcohol swab, but do not rub the area.

Step 15: Slowly remove the needle from the pen and discard it. Avoid recapping the needle as it increases the risk of needlestick injury.

Step 16: Replace the pen cap by pushing it straight on it.

After Injection:

• The patient can put away the used Insulin Aspart pen and needles in an FDA-approved sharps disposal container.

• Avoid disposing of loose pens and needles in the household trash.

• If the patient does not have an FDA-approved disposal container, the household container to be used must have the following qualities:

  • It should be made of heavy-duty plastic.

  • It should be closed with a puncture-resistant and tight-fitting lid.

  • It must be upright and stable to use.

  • It should be leak resistant.

• When the sharps disposal container is full, the patient must follow the appropriate community guidelines for waste disposal.

How Should the Patient Store the Insulin Aspart Touch Pen?

• Store the unused pens in the refrigerator at temperatures in the range of 36 to 46 degrees Fahrenheit.

• Store the pen out of the refrigerator at a temperature below 86 degrees Fahrenheit.

• Do not freeze the Insulin Aspart solution.

• Keep the drug away from heat or light.

• The pen must be used only till the expiration date.

Maintenance:

Handle the Insulin Aspart touch pen with care. Avoid dropping the pen as it might get damaged. In case the pen gets damaged, the patient must use a new one. Avoid soaking or washing the pen. In addition, the patient must keep the following things in mind:

1. Remove the needle from the pen after each injection for sterility and to prevent Insulin leakage.

2. Needles must be handled carefully to prevent needle stick injuries or other infectious diseases.

3. Keep the pen and injection needles away from children.

4. Avoid sharing needles or pens with other people.

5. Use a new needle for each injection.

6. Carry a spare Insulin device for precautionary measures.

Insulin Aspart Injection:

Read the instructions mentioned below to learn more about how to use the Insulin Aspart injection:

Supplies Required:

• 10 mL Insulin Aspart vial.

• Insulin syringe and needle.

• Alcohol swab.

Preparing the Insulin Aspart Dose:

• The patient must wash his hands with soap and water.

• Before preparing the injection, check the label to ensure the right drug type is taken.

• The solution must appear colorless, not thick, cloudy, or colored.

• Do not use the drug beyond the expiration date.

Step 1: Remove the tamper-resistant cap.

Step 2: Wipe the stopper with an alcohol swab.

Step 3: Hold the syringe upright and pull the plunger until its tip reaches the number of units on the prescribed dose.

Step 4: Gently push the needle through the rubber stopper.

Step 5: Push the plunger inside.

Step 6: Turn the vial and the syringe upside down. Pull the plunger out gently until the black tip is a few units beyond the dose. If air bubbles are present in the syringe, tap it a few times to prevent the formation of air bubbles.

Step 7: Slowly push the plunger upward until its tip reaches the line of the dose.

Step 8: Recheck the syringe to ensure that the right dose has been selected.

Step 9: Pull the syringe out of the rubber stopper attached to the vial.

Giving the Injection:

• Inject the solution of Insulin Aspart as per the doctor's instructions.

• The solution can also be injected under the skin of the stomach, thighs, buttocks, upper arms, and legs.

• Rotate the injection site each time the drug is injected.

• If Insulin Aspart is used in a pump, the patient must change the injection site every three days.

• The only type of Insulin that can be mixed with Insulin Aspart is the NPH type of Insulin.

Step 10: Choose the injection site, wipe it with a swab, and allow it to dry for some time.

Step 11: Insert the needle into the skin by pushing the plunger to inject the dose. The needle should remain in touch with the skin for six seconds.

Step 12: Withdraw the needle from the skin. If blood is visible at the site of injection, press the injection site lightly with a gauge or alcohol swab.

How Is Insulin Aspart Supplied or Stored?

100 units per mL of Insulin Aspart is available as a colorless and clear solution for injection in the following:

• 10 mL vials.

• 3 mL pen-shaped cartridges.

• 3 mL Insulin Aspart pen.

Storage:

The unused drug must be stored in a refrigerator at temperatures between two to eight degrees Celsius. Do not use the frozen drug or expose it to sunlight. In addition, Insulin Aspart should not be drawn into the syringe and stored for later use. The storage conditions are listed in the table below:

Use in a Specific Population:

Pregnancy:

Insulin Aspart is a pregnancy category B drug. There may be an associated risk of birth defects and other adverse effects, irrespective of drug exposure. Hence, it is important for patients with a history of hyperglycemia or gestational diabetes mellitus to establish good metabolic control. In addition, insulin requirements vary throughout the pregnancy. For example, they decrease during the first trimester, increase in the second trimester, and reduce in the third trimester. Therefore females must inform the doctor if they become pregnant during Insulin Aspart therapy.

Lactating Females:

Some amount of endogenous Insulin is present in human milk. However, no information is available regarding the presence of Insulin Aspart in human milk. Hence, Insulin Aspart must be administered cautiously to a lactating female. In addition, lactating mothers diagnosed with diabetes might require dosage adjustments.

Pediatric Use:

Insulin Aspart can be safely used in children for continuous subcutaneous infusion by the insulin pump. However, nothing has been known about the safety and efficacy of drugs in children below two years of age.

Geriatric Use:

No clinically significant differences were noted when Insulin Aspart was administered in people above 65 years of age.

Clinical Trial:

Adults With Type 2 Diabetes:

Two open-label, active-controlled studies were done on patients with type 1 diabetes mellitus for 24 weeks to compare the safety and efficacy of Insulin Aspart with regular human Insulin injections. Insulin Aspart was administered to these patients subcutaneously before meals, and the regular human Insulin injection was given 30 minutes before meals. The trial results are listed in the table below:

Adults With Type 2 diabetes:

An open-label, active-controlled study was done to compare the safety and efficacy of Insulin Aspart to regular human Insulin injection in patients with type 2 diabetes mellitus. Both drugs were administered before meals. The trial results are listed in the table below: