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Levemir Insulin Pen

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Last Updated: 25 September 2020

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General | Latest Info

Millions of people with diabetes use insulin therapy to help control their blood sugar. If you have type 2 diabetes, other medicines you are taking may not be getting you to your goal and may only last for part of the day. Levemir can be taken with other prescribed diabetes medicines. Adding Levemir as treatment can help keep your blood sugar within your target range for up to 24 hours. Your health care provider may have to give you a prescription for Levemir to help you reach your blood sugar goal. Levemir can be injected in the thigh, abdomen, or upper arm. It is important to change the injection site within your injection area each time you inject and not inject in the exact same spot each time. Rotating where you inject allows your body to absorb insulin and can help to prevent skin changes such as thickening or pitting, known as lipodystrophy. Your health care provider can show you how to inject Levemir before you start taking it.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Experience Levemir FlexTouch

Levemir is a brand - name prescription medication. It is used to lower blood sugar levels in: adults and children aged 2 years old and older with type 1 diabetes adults with type 2 diabetes. Levemir has not been studied in children younger than 2 years of age with type 1 diabetes. It also hasnt been studied in any children younger than 18 years of age with type 2 diabetes. Levemir contains the drug insulin detemir, which is long - acting insulin. Levemir is given as subcutaneous injection. Youll give yourself injections either once or twice a day based on your doctor or pharmacist's direction. Levemir came as a solution. The solution is available in two forms: vial and prefilled pen. A vial contains 10 milliliters of drug solution, with 100 units of insulin detemir per mL. It is used with a needle for injection. Needles are sold separately and may require prescription in certain states. The pen is called FlexTouch pen. Each pen contains 3 mL of drug solution, with 100 units of insulin detemir per mL.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Uses

Insulin detemir is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of heart attack or stroke. Insulin detemir is a man - made product that is similar to human insulin. It replaces insulin that your body would normally make. It acts longer than regular insulin, providing a low, steady level of insulin. It works by helping blood sugar get into cells so your body can use it for energy. Insulin detemir may be used with shorter - acting insulin product. It may also be used alone or with other diabetes drugs.


Side Effects

Get emergency medical help if you have signs of allergic reaction to Levemir: redness or swelling where injection was give, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat. Fluid retention - weight gain, swelling in your hands or feet, feeling short of breath; or low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling. Low blood sugar; weight gain; swelling in your hands and feet; rash, itching; or thickening or hollowing of skin where you inject medicine. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 - 800 - FDA - 1088.


What is Levemir?

Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor, diabetes educator, or pharmacist. Learn all preparation and usage instructions from your health care professional and product package. Before using, check this product visually for particles or discoloration. If either is present, do not use insulin. Insulin detemir should be clear and colorless. Before injecting each dose, clean the injection site with rubbing alcohol. Change where you inject each time to lessen the risk of problems or damage to skin. Insulin detemir may be injected in the stomach area, thigh, or back of upper arm. Do not inject into vein or muscle because very low blood sugar may occur. Do not rub area after injection. Do not inject into skin that is red, swollen, itchy, or damage. Do not inject cold insulin because this can be painful. The insulin container you are currently using can be kept at room temperature. Do not shake container. Inject this medication under the skin as directed by your doctor, usually once or twice daily. Insulin detemir is usually injected with evening meal or at bedtime. If you are using it twice a day, inject as direct by your doctor, usually your first dose in the morning and your second dose with evening meal, at bedtime, or 12 hours after the morning dose. This product should not be mixed with any other insulin. Do not use insulin detemir in infusion pump. Do not change brands or types of insulin without directions on how to do so from your doctor. Do not share your pen device with another person, even if the needle is change. You may give other people serious infection, or get serious infection from them. Learn how to store and discard medical supplies safely. Dosage is based on your medical condition and response to treatment. Measure each dose very carefully because even small changes in the amount of insulin may have a large effect on your blood sugar. Check your blood sugar regularly as directed by your doctor. Keep track of your results and share them with your doctor. This is very important in order to determine the correct insulin dose. Use this medication regularly to get the most benefit from it. To help you remember, use it at same time each day. Tell your doctor if your condition has not improving or if it worsen.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Side Effects

Levemir and Lantus are both long - acting injectable insulins that can be used for long - term management of diabetes. Insulin is a hormone that is naturally produced in the body by the pancreas. It helps convert glucose in your bloodstream into energy. This energy is then distributed to cells throughout your body. With diabetes, your pancreas produces little or no insulin or your body is unable to use insulin correctly. Without insulin, your body ca use sugars in your blood and can become starve for energy. Excess sugar in your blood can also damage different parts of your body, including your blood vessels and kidneys. Everyone with type 1 diabetes and many people with type 2 diabetes must use insulin to maintain healthy blood sugar levels. Levemir is a solution of insulin Detemir, and Lantus is a solution of insulin glargine. Insulin glargine is also available as brand Toujeo. Both insulin Detemir and insulin glargine are basal insulin formulas. That means that they work slowly to lower your blood sugar levels. Theyre both absorbed into your body over a 24 - hour period. They keep blood sugar levels lower for longer than short - acting insulin does Although formulations are slightly different, LEVEMIR and Lantus are very similar drugs. There are only a few differences between them.


Clinical Trial Experience

Because clinical trials are conducted under widely varying designs, adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect rates actually observed in clinical practice. Frequencies of Adverse reactions reported during LEVEMIR clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in Tables 1 - 4 below. See Tables 5 and 6 for hypoglycemia findings. In LEVEMIR add - on to liraglutide + metformin trial, all patients receive liraglutide 1. 8 mg + metformin during 12 - week run - in period. During the run - in period, 167 patients withdrew from the trial: 76 of these patients did so because of gastrointestinal adverse reactions and 15 did so due to other adverse events. Only those patients who completed the run - in period with inadequate glycemic control were randomized to 26 weeks of add - on therapy with LEVEMIR or continue, unchanged treatment with liraglutide 1. 8 mg + metformin. During this randomized 26 - week period, diarrhea was the only adverse reaction reported in 5% of patients treated with liraglutide 1. 8 mg + metformin and greater than in patients treated with liraglutide 1. 8 mg and metformin alone. In two pooled trials, total of 1155 adults with type 1 diabetes were exposed to individualized doses of LEVEMIR or NPH. The mean duration of exposure to LEVEMIR was 153 days, and total exposure to LEVEMIR was 321 years. The most common adverse reactions are summarized in Table 1. Table 1: Adverse reactions in two pooled clinical trials of 16 weeks and 24 weeks duration in adults with type 1 diabetes. A total of 320 adults with type 1 diabetes were exposed to individualized doses of LEVEMIR or insulin glargine. The mean duration of exposure to LEVEMIR was 176 days, and total exposure to LEVEMIR was 78 patient - years. The most common Adverse reactions are summarized in Table 2. Table 2: Adverse reactions in 26 - week trial comparing insulin aspart + LEVEMIR to insulin aspart + insulin glargine in adults with type 1 diabetes. In two pooled trials, total of 869 adults with type 2 diabetes were exposed to individualized doses of LEVEMIR or NPH. The mean duration of exposure to LEVEMIR was 157 days, and total exposure to LEVEMIR was 186 years. The most common adverse reactions are summarized in Table 3. Table 3: Adverse reactions in two pooled clinical trials of 22 weeks and 24 weeks duration in adults with type 2 diabetes. A total of 347 children and adolescents with type 1 diabetes were exposed to individualized doses of LEVEMIR or NPH. The mean duration of exposure to LEVEMIR was 180 days, and total exposure to LEVEMIR was 114 patient - years. The most common Adverse reactions are summarized in Table 4. Table 4: Adverse reactions in one 26 - week clinical trial of children and adolescents with type 1 diabetes


Proper Use

The dose of this medicine will be different for different patients. Follow your doctor's orders or directions on the label. The following information includes only average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of medicine. Also, number of doses you take each day, time allowed between doses, and length of time you take medicine depend on the medical problem for which you are using medicine. For injection dosage form: For type 1 diabetes: Adults, teenagers, and children 2 years of age and olderThe. Dose is based on your blood sugar and must be determined by your doctor. Children younger than 2 years of ageUse and dose must be determined by your doctor. For type 2 diabetes: dose is based on your blood sugar and must be determined by your doctor. Childrenuse's and dose must be determined by your doctor.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Interactions

A number of medications affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring. The following are examples of medications that may increase the blood - glucose - lowering effect of insulins, including LEVEMIR and, therefore, increase susceptibility to hypoglycemia: oral antidiabetic medications, Pramlintide acetate, angiotensin Converting enzyme inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates, somatostatin analogs, and sulfonamide antibiotics. Beta - blockers, clonidine, lithium salts, and alcohol may either increase or decrease the blood - glucose - lowering effect of insulin. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Signs of hypoglycemia may be reduced or absent in patients taking anti - adrenergic drugs such as beta - blockers, clonidine, guanethidine, and reserpine.


Side Effects

Many medications can cause side effects. Side effects are unwanted response to medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects list below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor. Following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be manage, and some may go away on their own over time. Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects. Numbness, weakness or pain in legs and arms, redness, itching, or swelling at the site of injection vision changes. Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention. Check with your doctor as soon as possible if any of the following side effects occur: fluid retention causing swollen joints, signs of allergic reaction, signs of low blood glucose, signs of low potassium in the body. Swollen joints stop taking medication and seek immediate medical attention If any of the following occur: seizures symptoms of serious allergic reaction unconsciousness some people may experience side effects other than those list. Check with your doctor if you notice any symptoms that worry you while you are taking this medication.


What is insulin detemir?

For pregnant women: Insulin detemir is a pregnancy category B drug. That means two things: studies of drugs in pregnant animals have shown risk to fetus. There are enough studies in pregnant women to show drugs pose a risk to the fetus. Tell your doctor if youre pregnant or plan to become pregnant. Insulin detemir should be used during pregnancy only if potential benefit justifies potential risk. For women who are breastfeeding: It isnt know if Insulin detemir passes through breast milk. You and your doctor may need to decide if youll take Insulin detemir or breastfeed. For seniors: You may be more sensitive to Insulin detemir, which may increase your risk of low blood sugar. Your doctor may start you at a lower dosage and make smaller dosage changes if needed. For children: safety and effectiveness of Insulin detemir has been established in children younger than 18 years with type 2 diabetes. The safety and effectiveness of Insulin detemir has been established in children younger than 2 years with type 1 diabetes. Keep Insulin detemir out of reach of children. Accidental injection can cause severe low blood sugar reaction. This can be fatal.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

DESCRIPTION

Levemir is a sterile solution of insulin detemir for use as subcutaneous injection. Insulin detemir is a long - acting recombinant human insulin analog. Levemir is produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification. Insulin detemir differs from human insulin in that amino acid threonine in position B30 has been omit, and the C14 fatty acid chain has been attached to amino acid B29. The Insulin detemir has a molecular formula of C 267 H 402 O 76 N 64 S 6 and a molecular weight of 5916. 9 It has the following structure: LEVEMIR is a clear, colorless, aqueous, neutral sterile solution. Each milliliter of LEVEMIR contains 100 units of insulin detemir, 65. 4 mcg zinc, 2. 06 mg m - cresol, 16. 0 mg glycerol, 1. 80 mg phenol, 0. 89 mg disodium phosphate dihydrate, 1. 17 mg of sodium chloride, and water for injection. Hydrochloric acid and / or sodium hydroxide may be added to adjust pH. Levemir has a pH of approximately 7.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

PRECAUTIONS

Hypoglycemia is the most common ADVERSE reaction of insulin therapy, including LEVEMIR. The Risk of Hypoglycemia increases with intensive glycemic control. When GLP - 1 receptor agonist is used in combination with LEVEMIR, LEVEMIR dose may need to be lower or more conservatively titrated to minimize risk of Hypoglycemia. All patients must be educated to recognize and manage Hypoglycemia. Severe Hypoglycemia can lead to unconsciousness or convulsions and may result in temporary or permanent impairment of brain function or death. Severe Hypoglycemia requiring assistance of another person or parenteral Glucose Infusion, or glucagon administration has been observed in clinical trials with insulin, including trials with LEVEMIR. The Timing of Hypoglycemia usually reflects the time - action profile of administered insulin formulations. Other factors, such as changes in food intake, exercise, and concomitant medications may also alter the risk of Hypoglycemia. The prolonged effect of subcutaneous LEVEMIR may delay recovery from Hypoglycemia. As with all insulins, use caution in patients with Hypoglycemia unawareness and in patients who may be predisposed to Hypoglycemia. A patient's ability to concentrate and react may be impaired as a result of Hypoglycemia. This may present risk in situations where these abilities are especially important, such as driving or operating other machinery. Early warning symptoms of Hypoglycemia may be different or less pronounce under certain conditions, such as longstanding diabetes, diabetic neuropathy, use of medications such as beta - blockers, or intensified glycemic control. These situations may result in severe Hypoglycemia prior to PATIENT's awareness of Hypoglycemia.


Side Effects

Get emergency medical help if you have signs of an insulin allergy: redness or swelling where the injection was give, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat. Fluid retention - weight gain, swelling in your hands or feet, feeling short of breath; or low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling. Low blood sugar; weight gain; swelling in your hands and feet; rash, itching; or thickening or hollowing of skin where you inject medicine. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 - 800 - FDA - 1088.


What is insulin detemir?

Insulin detemir will be one - third of your total daily insulin requirement. The rest of your daily dose will be short - or rapid - acting insulin. Insulin detemir will be one - third of your total daily insulin requirement. The rest of your daily dose will be short - or rapid - acting insulin. The safety and effectiveness of insulin detemir has been established in children younger than 2 years old with type 1 diabetes. You may be more sensitive to insulin detemir, which may increase your risk of low blood sugar. Your doctor may start you at a lower dosage and make smaller dosage changes if needed.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

CLINICAL PHARMACOLOGY

Insulin DETEMIR is a recombinant, soluble, long - acting basal INSULIN analog. Fatty acid acylation allows for protracted duration of effect with no pronounced peak via delayed absorption due to albumin binding in Subcutaneous adipose tissue and plasma. Unlike INSULIN glargine and NPH INSULIN, INSULIN DETEMIR is soluble at neutral pH and exists as liquid following Subcutaneous Injection, increasing surface area and reducing variability in absorption. Insulin DETEMIR is used in adult and pediatric patients 2 years and older with Type 1 Diabetes mellitus, and adults with Type 2 DM. Insulin DETEMIR has been used in CHILDREN and adolescents with Type 2 DM; however, oral agents are typically first - line therapy. Basal INSULIN may be added to Metformin therapy in pediatric patients with Type 2 DM when additional glycemic control is needed. INSULIN DETEMIR is considered to be equipotent to NPH INSULIN. Advantages of INSULIN DETEMIR versus NPH INSULIN, For example, can include less variability in patient response, similarity or improvement in glycemic control, less weight gain, and decrease in incidence of hypoglycemia, including both nocturnal and severe hypoglycemia. No clinically relevant differences regarding glucose control between INSULIN DETEMIR and INSULIN glargine have been demonstrated in adults with Type 1 or Type 2 Diabetes mellitus;. However, to achieve glycemic control, INSULIN DETEMIR may need to be administered twice daily. Insulin glargine and INSULIN DETEMIR had similar rates of A1C reduction in the 52 - week Clinical Trial of INSULIN - naive patients taking basal INSULIN as add - on therapy to oral glucose - lowering medications; A1C decreased by 1. 5% in both treatment groups. In treatment of Type 1 DM, INSULIN therapy may be initiated with basal - bolus regimen of INSULIN DETEMIR and then further Individualize to achieve treatment goals. In treatment of Type 2 DM, INSULIN is generally reserved for patients who continue to have A1C above target despite dual / triple therapy with Metformin and other antidiabetic agents. In patients who need greater glucose - lowering effect of injectable medication, GLP - 1 receptor agonists are the preferred choice to INSULIN. Evidence from trials comparing GLP - 1 RAs and INSULIN shows similar or even better efficacy in A1C reduction; GLP - 1 RAs have lower risk of hypoglycemia and are associated with reductions in body weight compared to weight gain with INSULIN. In patients who cannot tolerate GLP - 1 RA, or who fail to meet glycemic targets with dual / triple therapy, INSULIN therapy with basal INSULIN, such as INSULIN DETEMIR should be initiated and titrated to target. If A1C remains above target, prandial INSULIN should be add. Consider initial Injectable combination if A1C is greater than 10% and 2% above target. Consider early introduction of INSULIN if there is evidence of ongoing catabolism, if symptoms of hyperglycemia are present, or when A1C levels or blood glucose levels are very high. In patients who are starting on INSULIN therapy and are taking thiazolidinedione or sulfonylurea, discontinue or reduce the dose of oral medication. General ADMINISTRATION Information For storage Information, see Specific product Information within How Supplied section.


ADVERSE REACTIONS

Because clinical trials are conducted under widely varying designs, adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect rates actually observed in clinical practice. Frequencies of Adverse Reactions reported during LEVEMIR clinical trials in patients with Type 1 Diabetes mellitus and Type 2 Diabetes mellitus are listed in Tables 1 - 4 below. See Tables 5 and 6 for hypoglycemia findings. In two pooled trials, adults with Type 1 Diabetes were exposed to individualized doses of LEVEMIR or NPH. The mean duration of exposure to LEVEMIR was 153 days, and total exposure to LEVEMIR was 321 years. The Most common Adverse Reactions are summarized in Table 1. Adults with Type 1 Diabetes were exposed to LEVEMIR or Insulin glargine. The mean duration of exposure to LEVEMIR was 176 days, and total exposure to LEVEMIR was 78 patient - years. The Most common Adverse Reactions are summarized in Table 2. In two pooled trials, adults with Type 2 Diabetes were exposed to LEVEMIR or NPH. The mean duration of exposure to LEVEMIR was 157 days, and total exposure to LEVEMIR was 186 years. The most common Adverse Reactions were comparable to those observed in adult patients with Type 1 Diabetes mellitus; see Table 1. Pediatric patients with Type 1 Diabetes were exposed to individualized doses of LEVEMIR or NPH. The mean duration of exposure to LEVEMIR was 180 days, and total exposure to LEVEMIR was 114 patient - years. The Most common Adverse Reactions are summarized in Table 3. Adverse Reactions in pregnant patients occurring at an incidence of 5% are shown in Table 4. Two most common adverse reactions were nasopharyngitis and headache. These are consistent with findings from other Type 1 Diabetes trials, and are not repeated in Table 4. The Incidence of Adverse Reactions of pre - eclampsia was 10. 5% and 7. 0% in LEVEMIR and NPH Insulin groups respectively. Out of the total number of cases of pre - eclampsia, eight cases in the LEVEMIR group and 1 case in the NPH Insulin group require hospitalization. Rates of pre - eclampsia observed in the study are within expected rates for pregnancy complicated by Diabetes. Pre - eclampsia is a syndrome defined by symptoms, hypertension and proteinuria; definition of pre - eclampsia was not standardized in the trial, making it difficult to establish a link between giving treatment and increased risk of pre - eclampsia. All events were considered unlikely to relate to trial treatment. In all nine cases requiring hospitalization, women had healthy infants. Events of hypertension, proteinuria and edema were reported less frequently in the LEVEMIR group than in the NPH Insulin group as whole. There was no difference between treatment groups in mean blood pressure during pregnancy and there was no indication of general increase in blood pressure.


CLINICAL STUDIES

Efficacy and safety of LEVEMIR given once - daily at bedtime or twice - daily was compared to that of once - daily or twice - daily NPH human insulin or once - daily insulin glargine in non - blind, randomize, parallel studies of 6004 patients with diabetes. In general, patients treated with LEVEMIR achieve levels of glycemic control similar to those treated with NPH human insulin or insulin glargine, as measured by glycosylated hemoglobin. In one non - blind clinical study, adult patients with Type 1 diabetes were randomized to treatment with either LEVEMIR at 12 - hour intervals, LEVEMIR morning and bedtime or NPH human insulin morning and bedtime. Insulin aspart was also administered before each meal. At 16 Weeks of Treatment, combined LEVEMIR - treated patients had similar HbA 1c and Fasting plasma glucose reductions to NPH - treated patients. Differences in timing of LEVEMIR administration had no effect on HbA 1c, FPG, body weight, or risk of having hypoglycemic episodes. Overall glycemic control achieved with LEVEMIR was compared to that achieved with insulin glargine in a randomize, non - blind, clinical study in which patients with Type 1 diabetes were treated for 26 weeks with either twice - daily LEVEMIR or once - daily insulin glargine. Insulin aspart was administered before each meal. Levemir - treated patients had a decrease in HbA 1c similar to that of insulin glargine - treated patients. In a randomized, control clinical study, patients with Type 1 diabetes were treated with once - daily LEVEMIR or NPH human insulin, both in combination with human soluble insulin before each meal for 6 months. Levemir and NPH human insulin had similar effects on HbA 1c. In a non - blind, randomize, controlled clinical study, pediatric patients with Type 1 diabetes were treated for 26 weeks with a basal - bolus insulin regimen. Levemir and NPH human insulin were administered once - or twice - daily according to a pretrial dose regimen. Bolus insulin aspart was administered before each meal. Levemir - treated patients had a decrease in HbA 1c similar to that of NPH human insulin. In a 24 - week, non - blind, randomize, clinical study, LEVEMIR administered twice - daily was compared to a similar regimen of NPH human insulin as part of a regimen of combination therapy with one or two of the following oral antidiabetes agents. Levemir and NPH similarly lower HbA 1c from baseline. In a 22 - week, non - blind, randomize, clinical study in adults with Type 2 diabetes, LEVEMIR and NPH human insulin were given once - or twice - daily as part of basal - bolus regimen. As measured by HbA 1c or FPG, LEVEMIR had efficacy similar to NPH human insulin.


Information for Patients

See FDA - approved Patient Labeling advises patients that they must never share LEVEMIR FlexTouch Pen with another person, even if the needle is change. Advise patients using LEVEMIR vials not to share needles or syringes with another person. Sharing poses a risk for transmission of blood - borne pathogens. Instruct patients on self - management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of LEVEMIR therapy. Instruct patients on the handling of special situations such as intercurrent conditions, inadequate or skipped insulin dose, inadvertent ADMINISTRATION of increased insulin dose, inadequate food intake, and skipping meals. Instruct patients on management of hypoglycemia. Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. Advise patients who have frequent hypoglycemia or reduce or absent warning signs of hypoglycemia to use caution when driving or operating machinery. Advise patients that hypersensitivity reactions have occurred with LEVEMIR. Inform patients on symptoms of hypersensitivity reactions. Instruct patients to always check the insulin label before each injection to avoid mix - ups between insulin products. Novo Nordisk, LEVEMIR, NovoLog, FlexTouch, NovoFine, and NovoTwist are registered trademarks of Novo Nordisk / S.


Pharmacodynamics

Insulin detemir is a soluble, long - acting basal human insulin analog with up to 24 - hour duration of action. The pharmacodynamic profile of LEVEMIR is relatively constant with no pronounced peak. Duration of action of LEVEMIR is mediated by slowed systemic absorption of insulin detemir molecules from the injection site due to self - association of drug molecules. In addition, distribution of insulin detemir to peripheral target tissues is slow because of binding to albumin. Figure 2 shows results from a study in Patients with Type 1 Diabetes conducted for a maximum of 24 hours after subcutaneous injection of LEVEMIR or NPH insulin. Mean time between injection and end of pharmacological effect for insulin detemir ranges from 7. 6 hours to > 24 hours. Figure 2: Activity Profiles in Patients with Type 1 Diabetes in 24 - hour Glucose Clamp Study AUC GIR: Area Under Curve for Glucose Infusion Rate GIR max: Maximum Glucose Infusion Rate for doses at interval of 0. 2 to 0. 4 Units / kg, insulin detemir exerts more than 50% of its maximum effect from 3 to 4 hours up to approximately 14 hours after dose administration. Figure 3 shows Glucose Infusion Rate results from 16 - hour Glucose Clamp Study in Patients with Type 2 Diabetes. Clamp Study was terminated at 16 hours according to protocol. Figure 3: Activity Profiles in Patients with Type 2 Diabetes in 16 - hour Glucose Clamp Study

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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