Side effects of levemir insulin

Levemir Dosage

Dosing

LEVEMIR is a recombinant human insulin analog for once- or twice-daily subcutaneous administration.

Patients treated with LEVEMIR once-daily should administer the dose with the evening meal or at bedtime.

Patients who require twice-daily dosing can administer the evening dose with the evening meal, at bedtime, or 12 hours after the morning dose.

The dose of LEVEMIR must be individualized based on clinical response. Blood glucose monitoring is essential in all patients receiving insulin therapy.

Patients adjusting the amount or timing of dosing with LEVEMIR should only do so under medical supervision with appropriate glucose monitoring .

In patients with type 1 diabetes, LEVEMIR must be used in a regimen with rapid-acting or short-acting insulin.

As with all insulins, injection sites should be rotated within the same region (abdomen, thigh, or deltoid) from one ​injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis .

​During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring .

LEVEMIR can be injected subcutaneously in the thigh, abdominal wall, or upper arm. As with all insulins, the rate of absorption, and consequently the onset and duration of action, may be affected by exercise and other variables, such as stress, intercurrent illness, or changes in co-administered medications or meal patterns.

​LEVEMIR FlexTouch dials in 1-unit increments.

​Use LEVEMIR FlexTouch with caution in patients with visual impairment who may rely on audible clicks to dial their dose.

When using LEVEMIR with a glucagon-like peptide (GLP)-1 receptor agonist, administer as separate injections. Never mix. It is acceptable to inject LEVEMIR and a GLP-1 receptor agonist in the same body region but the injections should not be adjacent to each other.

Diabetes Forecast

Are you new to using insulin? Or do you want to refine your current technique? While the basics of injecting are fairly straightforward, the day-to-day ins and outs of balancing insulin, food, and physical activity can be confounding even for a veteran.

Understanding the different types of insulin and how they will affect you is a good first step toward making sure you’re using them properly. First, there’s “background” insulin, which works all day long to steady blood glucose levels. This group includes insulin glargine (Lantus), insulin detemir (Levemir), and NPH (Humulin N and Novolin N).

How Does Insulin Work?

The graphs here show at a glance how long it takes for each type of insulin to begin working, when the dose reaches its peak, and how long it lasts.

On the other hand, “mealtime” insulin starts working fast to make sure a meal doesn’t raise your glucose levels too high. Unlike background insulin, mealtime insulin stays in your system for only three to six hours. The mealtime insulins are insulin lispro (Humalog), insulin aspart (NovoLog), insulin glulisine (Apidra), and regular insulin (Humulin R and Novolin R). In addition, some people use premixed insulins, combinations of mealtime and background insulins.

HOW TO: Cover carbs with insulin

Here’s the most basic thing you need to know: Carbohydrates in food raise your blood glucose. Insulin lowers it. That’s why your doctor will probably tell you to use a certain number of units of insulin to cover the carbohydrates you eat. “That’s individualized,” says Caroline Bohl, MS, RD, CDE, a diabetes educator with the Naomi Berrie Diabetes Center at Columbia University Medical Center. “Each person will know one unit covers a certain number of carbs.”

It’s generally best to inject mealtime insulin up to 15 minutes before you plan to eat if you are using Humalog, NovoLog, or Apidra. For Humulin R and Novolin R, the timing is 30 to 45 minutes prior to the meal. Inject any longer before a meal and you run the risk of hypoglycemia, since the insulin will kick in before there’s any food for it to work on. (If you administer a mealtime dose but aren’t able to eat, you may need to take glucose tablets or other fast-acting carbs to prevent your blood glucose from dropping.) Taken before you eat, on the other hand, the insulin will lower your blood glucose level just as your meal is raising it. The result? Numbers that don’t spike.

Of course, it’s more complicated than that. “We know that higher-fat, higher-protein meals along with higher carbohydrates can slow the absorption ,” says Amy Hess-Fischl, MS, RD, LDN, BC-ADM, CDE, coordinator of the teen transition program at the University of Chicago Kovler Diabetes Center. When you eat a high-fat food (say, pizza) after taking mealtime insulin, your blood glucose levels may drop shortly after eating, then skyrocket hours later once your body registers the food. In that case you may need to split a dose, taking half of your allotted insulin 15 minutes before the meal and the rest when you’re done eating.

That’s assuming you’re at your target blood glucose level before eating. If your numbers are running high, on the other hand, you’ll have to correct pre-meal. You can give both the correction and mealtime doses at the same time prior to eating.

For the best picture of how foods affect you, use your blood glucose meter to test two hours after a meal. “To see how a bagel works instead of pizza, test often,” says Bohl. You won’t have to do this forever, but it’s a good way to understand how your body reacts to different meals. Discovering how various foods affect your blood glucose—and therefore your insulin dosing—is important because reactions to carbohydrates are individualized. “Alcohol has the potential to lower blood glucose, but there are some people who have a glass of wine and … go high,” says Hess-Fischl.

A lot of the disparity in how different foods affect blood glucose levels is a result of a factor known as the glycemic load. Foods with high glyemic loads raise blood glucose more quickly than those with low ones. That’s why, in part, you might have more of a spike after eating refined carbs than with whole grains. Still, this is more of a general guide than a fixed set of rules. “People really have to know what works for them,” says Sharlene Emerson, CRNP, BC-ADM, CDE, a diabetes educator with the University of Pittsburgh Medical Center. Pay attention, and you’ll soon begin to notice which foods have a particularly bad or good effect on your blood glucose numbers.

HOW TO: Correct a high

Your blood glucose level is soaring. You need more insulin. But how much? The amount one unit of insulin will lower your blood glucose is called your insulin sensitivity factor, or ISF. You’ll work with your doctor or diabetes educator to determine the number of units of insulin that safely lowers your levels without risking hypoglycemia. And since the ISF is highly individual (one unit of insulin may lower an adult’s blood glucose by, say, 30 mg/dl, while a child’s level may drop by 100 or 150), it requires a bit of testing. Check your blood glucose two hours after injecting, says Hess-Fischl. If it’s within 50 mg/dl of your goal, your correction factor is spot-on. If your level is higher, try correcting with more insulin next time you’re high. Too low? Use less insulin to correct a high.

If you just ate and your blood glucose is high, hold off on a correction dose until your mealtime insulin is out of your system (about three to four hours). Likewise, if your blood glucose is still high after a correction dose, give it time. Injecting another dose too soon after a previous dose can result in “stacking” of the insulin doses, and can lead to dangerously low blood glucose. “If somebody’s correcting high blood sugar without , I usually tell people going to take 45 minutes to start coming down,” says Bohl. “Usually give the insulin two to three hours to work. Be a little cautious to not overcorrect. Sometimes patients keep doing it, and they just plummet.” You’ll want to work with your care provider to figure out what’s best for you. It may take time to get it right.

HOW TO: Exercise without going low

Exercise lowers blood glucose levels, so hypoglycemia during or after a workout is a real worry. But, according to Bohl, it’s manageable. “I tell people they need to have a gauge of how much their exercise makes their blood sugar drop,” she says. Sounds easy, right? While finding this number will take a bit of trial and error, it should be safe to start exercising when your blood glucose is at 150 mg/dl. Test before, during, and after your activity to see how it affects your level. Don’t forget to test later in the day, too; some people have a drop in blood glucose hours after a workout.

Another tip: “Inject in an area that’s not affected by the exercise,” says Emerson. If you’re going for a run, inject insulin into your abdomen, not your leg. Since you’ll be working your leg muscles during the exercise, insulin injected there will be absorbed more quickly than the same amount injected elsewhere in the body.

Once you know how your body reacts to physical activity, you can determine a blood glucose level that’s safe for exercising. Some people will work out when their blood glucose is a little above their target range, knowing it will drop. (Avoid exercising when blood glucose is above 250 mg/dl, however.) Others will eat a carbohydrate-containing snack or a glucose tablet to raise their glucose and prevent a low. Athletes who are on a regular schedule might adjust their insulin to make up for a workout. One of Hess-Fischl’s patients always exercises after lunch, so she cuts her pre-lunch insulin dose by half. If and how you’ll modify your insulin dosages is a matter to discuss with your doctor or diabetes educator.

There’s a lot to learn, and that can seem daunting. But as long as you keep testing to understand how insulin affects your body, you can achieve good glucose control. In time, you’ll be a wiz.

An insulin Q & A

Q: If my blood glucose is 70 to 80 mg/dl and stable before mealtime, should I still take the same amount of insulin I would normally take to cover the carbs?
A: If your blood glucose is on the lower side of normal, you can reduce your mealtime insulin dose by a small percentage. How much less you should take is tricky since there’s no general rule; you’ll need to work that out with your doctor. And keep in mind that if you’re experiencing hypoglycemia before a meal, you should treat it with fast-acting carbs first. Then, when you’re certain your blood glucose isn’t falling, dose insulin for a meal and eat right away.

Q: Should I take insulin if I’m only having a small snack with very few carbs?
A: Probably not. People with type 1 diabetes, and those with type 2 who use mealtime insulin to cover carbs, need to cover most food with insulin, but not if it is a snack of 15 grams of carbohydrates or less.

Q: Why can’t I just eat anything I want (say, a tub of ice cream) and cover it with mealtime insulin—even if that means a lot of insulin?
A: It’s important to pay attention to good nutrition whether you have diabetes or not. Indulging in anything and everything you want will only set you up for weight gain, high LDL (“bad”) cholesterol, and high blood pressure. And while taking large doses of insulin isn’t necessarily a bad thing if your body requires it, loading up in order to cover a jumbo meal puts you at risk for hypoglycemia. Since your body can only digest so much food at once (and fat in foods slows digestion even more), a supersized dose of insulin may hit the blood before your entire meal is digested, causing low blood glucose. Then, after your meal is fully digested, your level can spike.

Q: If I take background insulin before I go to sleep at night, will it affect me differently than if I take it in the morning?
A: It depends on the type of background insulin and how long it lasts. In some people, the effect may start to wane before the next dose. So if you inject in the morning, you may experience a rise in blood glucose the following morning as the insulin wears off. There’s a greater difference with NPH, which lasts a shorter amount of time. Regardless of the type of background insulin you use, you should inject at the same time each day or night to keep blood glucose levels stable.

Q: Should I still take the same mealtime insulin before lunch if I just worked out and tend to go low a couple of hours after exercise?
A: Yes, but take a smaller dose. You’ll want to take about half as much insulin as you normally would for this meal. The drop you experience from working out will bring you to your goal.

(Managing Dawn Phenomenon with Basal Insulin is excerpted from Think Like A Pancreas: A Practical Guide to Managing Diabetes With Insulin by Gary Scheiner MS, CDE, DaCapo Press, 2011)

The liver is a fascinating organ. It does about a hundred different things. One of its main functions is to store glucose (in a dense, compact form called “glycogen”) and secrete it steadily into the bloodstream in order to provide our body’s vital organs and tissues with a constant source of fuel. This is what keeps your heart beating, brain thinking, lungs breathing and digestive system, uh, digesting, pretty much all the time.

In order to transfer the liver’s steady supply of glucose into the body’s cells, the pancreas normally secretes a small amount of insulin into the bloodstream every couple of minutes. This is called basal insulin. Not only does basal insulin ensure a steady energy source for the body’s cells, it also keeps the liver from dumping out too much glucose all at one. Too little basal insulin, or a complete lack of insulin, would result in a sharp rise in blood sugar levels.

So, you might say that basal insulin and the liver are in “equilibrium” with each other. The basal insulin should match the liver’s secretion of glucose throughout the day and night. In the absence of food, exercise and rapid-acting/mealtime insulin, the basal insulin should hold the blood sugar level nice & steady.

Each person’s basal insulin requirement is unique. Typically, basal insulin needs are highest during the night and early morning, and lowest in the middle of the day. This is due to the production of blood sugar–raising hormones during the night, and enhanced sensitivity to insulin that comes with daytime physical activity. Two hormones in particular – cortisol and growth hormone – cause the liver’s natural ebb and flow in glucose secretion.

During a person’s growth years (prior to age 21), basal insulin needs tend to be relatively high throughout the night, drop through the morning hours, and gradually increase from noon to midnight. Most adults (age 21+) exhibit an abrupt increase in basal insulin requirements during the early morning hours, followed by a drop-off until noontime, a low/flat level in the afternoon, and a gradual increase in the evening. This peak in basal insulin during the early morning hours is commonly referred to as a dawn phenomenon.

Basal insulin can be supplied in a variety of ways. Intermediate-acting insulin (NPH) taken once daily will usually provide background insulin around the clock, albeit at much higher levels 4 to 8 hours after injection and at much lower levels at 16 to 24 hours. Long-acting basal insulins (glargine and detemir) offer relatively peakless insulin levels for approximately 24 hours. Insulin pumps deliver rapid-acting insulin in small pulses throughout the day and night. With a pump, the basal insulin level can be adjusted and fine-tuned to match the body’s ebb and flow in basal insulin needs. It is also possible to combine various forms of long-acting insulin to simulate the body’s normal basal insulin secretion.

The following figures illustrate the action profiles of various types of basal insulin programs.

Basal insulin supplied by NPH at bedtime

The main advantage of this program is the peak that occurs during the pre-dawn hours. The disadvantages include the unpredictability of the peak (due to NPH’s varied rate of absorption from day to day), the potential for low glucose in the early morning (due to the significant peak during the night) and the likelihood that that late afternoon/evening blood sugar will rise as the NPH tapers off.

Basal insulin supplied by NPH in the morning and evening

The advantages of this program are the peak in basal insulin during the night and the possibility of using the morning NPH peak to cover the carbs eaten at lunchtime. The drawbacks are the same as those in Figure 3 above, plus the major issue of having to conform to a rigid meal/snack schedule during the day due to the peak of the morning NPH insulin. As the graphic clearly shows, this type of basal insulin program does a poor job of matching the body’s needs. It rarely produces stable glucose levels – particularly during the daytime.

Unfortunately, those who use “premixed” insulin twice daily are, essentially, utilizing this approach for their basal program. Each injection of premixed insulin contains anywhere from 50-75% NPH insulin, with the remainder being either Regular or rapid-acting insulin.

Basal insulin supplied by glargine (Lantus) or detemir (Levemir)

Glargine (Lantus) is usually taken once daily, but sometimes is taken twice – particularly when low doses are being used. Detemir (Levemir) is usually taken twice daily, but occasionally can be taken once a day. When basal insulin is injected twice daily, it is reasonable to split the doses evenly and take them approximately 12 hours apart. Taking more in the evening and less in the morning does not usually produce a desired “peak” at any particular time. When taken once daily, it is usually best to take the injection in the morning on a consistent 24-hour cycle. Research has shown that the morning injection has the least potential to cause an undesired blood sugar rise when the insulin is tapering off at around 20-24 hours.

The main advantage of using glargine or detemir is the relatively unwavering flow of insulin (a very slight peak may occur 6 to 10 hours after injection of detemir) and consistent absorption pattern. The disadvantages include the potential for a gradual blood sugar rise during the night (due to the lack of a pre-dawn peak) and around the time of the injection when the insulin is taken once daily (the basal insulin may “wear off” a few hours early and take a few hours to “kick in”). There is also potential for a gradual blood sugar drop in the afternoon as the basal insulin level may exceed the liver’s production of glucose.

Basal insulin supplied by Glargine or Detemir plus Evening NPH

In order to overcome some of the potential problems created by using only basal or NPH insulin to meet the body’s basal needs, it is possible to combine the two. When NPH is added at nighttime, glargine or detemir can be taken once daily at a lower dose than if used without NPH. This minimizes the risk of having glucose levels drop between meals during the day. By adding a modest evening or bedtime dose of NPH, a nighttime/early-morning peak can be achieved. This program offers the unique advantage of allowing day-to-day adjustment of the overnight basal insulin level by making minute changes to the NPH dose without affecting the basal insulin level the following day.

The disadvantages include the need for at least two separate injections and the filling of multiple prescriptions. There is also potential for mixing up doses or taking the wrong insulin at the wrong time since several different types of insulin are being utilized simultaneously.

Basal insulin supplied by Insulin Pump Therapy

Pump therapy offers the greatest degree of maneuverability in terms of matching basal insulin to the body’s needs. Because small pulses of rapid-acting insulin are used to deliver basal insulin, variations in peak or action time are not an issue. Changes can be made to the basal insulin delivery on the hour or half-hour, so “peaks and valleys” can easily be built into the program. Pumps also permit temporary changes to basal insulin levels in order to accommodate short-term changes in basal insulin needs (for situations such as illness, high/low activity levels, and stress).

Perhaps the greatest drawback to delivering basal insulin with a pump is the risk of ketoacidosis. Any mechanical problem resulting in a lack of basal insulin delivery can result in a severe insulin deficiency in just a few hours. Without any insulin in the bloodstream, the body’s cells begin burning large amounts of fat (instead of sugar) for energy. The result is the production of acidic ketone molecules—a natural waste product of fat metabolism. This rarely occurs when taking injections of long-acting insulin since there is almost always some insulin working as long as injections are not missed.

Successful pump use will require adequate follow-up and fine-tuning. This should include:

  • Basal rate testing throughout the day and night (fasting for 8- to 10-hour intervals and testing blood sugars to see if they are holding steady)
  • Fine-tuning of bolus formulas (based on record-keeping)
  • Troubleshooting and prevention of emergencies such as DKA (diabetic ketoacidosis); and
  • Use of advanced pump features such as extended boluses and temporary basal rates.

Suggested next post: My Experiments with Managing Dawn Phenomenon

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Levemir

SIDE EFFECTS

The following adverse reactions are discussed elsewhere:

  • Hypoglycemia
  • Hypersensitivity and allergic reactions

Clinical Trial Experience

Because clinical trials are conducted under widely varying designs, the 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 the rates actually observed in clinical practice.

The frequencies of adverse reactions (excluding hypoglycemia) 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 the hypoglycemia findings.

In the LEVEMIR® add-on to liraglutide+metformin trial, all patients received liraglutide 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing 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 continued, 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 (11.7%) and greater than in patients treated with liraglutide 1.8 mg and metformin alone (6.9%).

In two pooled trials, a total of 1155 adults with type 1 diabetes were exposed to individualized doses of LEVEMIR® (n=767) or NPH (n=388). The mean duration of exposure to LEVEMIR® was 153 days, and the total exposure to LEVEMIR® was 321 patient-years. The most common adverse reactions are summarized in Table 1.

Table 1: Adverse reactions (excluding hypoglycemia) in two pooled clinical trials of 16 weeks and 24 weeks duration in adults with type 1 diabetes (adverse reactions with incidence ≥ 5%)

A total of 320 adults with type 1 diabetes were exposed to individualized doses of LEVEMIR® (n=161) or insulin glargine (n=159). The mean duration of exposure to LEVEMIR® was 176 days, and the total exposure to LEVEMIR® was 78 patient-years. The most common adverse reactions are summarized in Table 2.

Table 2: Adverse reactions (excluding hypoglycemia) in a 26-week trial comparing insulin aspart + LEVEMIR® to insulin aspart + insulin glargine in adults with type 1 diabetes (adverse reactions with incidence ≥ 5%)

In two pooled trials, a total of 869 adults with type 2 diabetes were exposed to individualized doses of Levemir® (n=432) or NPH (n=437). The mean duration of exposure to LEVEMIR® was 157 days, and the total exposure to LEVEMIR® was 186 patient-years. The most common adverse reactions are summarized in Table 3.

Table 3: Adverse reactions (excluding hypoglycemia) in two pooled clinical trials of 22 weeks and 24 weeks duration in adults with type 2 diabetes (adverse reactions with incidence ≥ 5%)

LEVEMIR®,%
(n =432)
NPH, %
(n= 437)
Upper respiratory tract infection 12.5 11.2
Headache 6.5 5.3

A total of 347 children and adolescents (6-17 years) with type 1 diabetes were exposed to individualized doses of LEVEMIR® (n=232) or NPH (n=115). The mean duration of exposure to LEVEMIR® was 180 days, and the total exposure to LEVEMIR® was 114 patient-years. The most common adverse reactions are summarized in Table 4.

Table 4: Adverse reactions (excluding hypoglycemia) in one 26-week clinical trial of children and adolescents with type 1 diabetes (adverse reactions with incidence ≥ 5%)

Pregnancy

A randomized, open-label, controlled clinical trial has been conducted in pregnant women with type 1 diabetes.

Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including LEVEMIR® .

Tables 5 and 6 summarize the incidence of severe and non-severe hypoglycemia in the LEVEMIR® clinical trials.

For the adult trials and one of the pediatric trials (Study D), severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring assistance of another person and associated with either a plasma glucose value below 56 mg/dL (blood glucose below 50 mg/dL) or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration. For the other pediatric trial (Study I), severe hypoglycemia was defined as an event with semi-consciousness, unconsciousness, coma and/ or convulsions in a patient who could not assist in the treatment and who may have required glucagon or intravenous glucose.

For the adult trials and pediatric Study D, non-severe hypoglycemia was defined as an asymptomatic or symptomatic plasma glucose < 56 mg/dL (or equivalently blood glucose < 50 mg/dL as used in Study A and C) that was self-treated by the patient. For pediatric Study I, non-severe hypoglycemia included asymptomatic events with plasma glucose < 65 mg/dL as well as symptomatic events that the patient could self-treat or treat by taking oral therapy provided by the caregiver.

The rates of hypoglycemia in the LEVEMIR® clinical trials (see Clinical Studies) were comparable between LEVEMIR®-treated patients and non-LEVEMIR®-treated patients (see Tables 5 and 6).

Table 5: Hypoglycemia in Patients with Type 1 Diabetes

Table 6: Hypoglycemia in Patients with Type 2 Diabetes

Study E Type 2 Diabetes Adults 24 weeks In combination with oral agents Study F Type 2 Diabetes Adults 22 weeks In combination with insulin aspart Study H Type 2 Diabetes Adults 26 weeks in combination with Liraglutide and Metformin
Twice-Daily LEVEMIR® Twice-Daily NPH Once- or Twice Daily LEVEMIR® Once- or Twice Daily NPH Once Daily LEVEMIR® + Liraglutide + Metformin Liraglutide + Metformin
Severe hypoglycemia Percent of patients with at least 1 event (n/total N) 0.4 (1/237) 2.5 (6/238) 1.5 (3/195) 4.0 (8/199) 0 0
Event/patient/year 0.01 0.08 0.04 0.13 0 0
Non-severe hypoglycemia Percent of patients (n/total N) 40.5 (96/237) 64.3 (153/238) 32 3 (63/195) 32.2 (64/199) 9.2 (15/163) 1.3 (2/158*)
Event/patient/year 3.5 6.9 1.6 2.0 0.29 0.03
*One subject is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study

Insulin Initiation and Intensification of Glucose Control

Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.

Lipodystrophy

Long-term use of insulin, including LEVEMIR®, can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption. Rotate insulin injection sites within the same region to reduce the risk of lipodystrophy .

Weight Gain

Weight gain can occur with insulin therapy, including LEVEMIR®, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria .

Peripheral Edema

Insulin, including LEVEMIR®, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Allergic Reactions

Local Allergy

As with any insulin therapy, patients taking LEVEMIR® may experience injection site reactions, including localized erythema, pain, pruritus, urticaria, edema, and inflammation. In clinical studies in adults, three patients treated with LEVEMIR® reported injection site pain (0.25%) compared to one patient treated with NPH insulin (0.12%). The reports of pain at the injection site did not result in discontinuation of therapy.

Rotation of the injection site within a given area from one injection to the next may help to reduce or prevent these reactions. In some instances, these reactions may be related to factors other than insulin, such as irritants in a skin cleansing agent or poor injection technique. Most minor reactions to insulin usually resolve in a few days to a few weeks.

Systemic Allergy

Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypoten­sion, and shock may occur with any insulin, including LEVEMIR®, and may be life-threatening .

Antibody Production

All insulin products can elicit the formation of insulin antibodies. These insulin antibodies may increase or decrease the efficacy of insulin and may require adjustment of the insulin dose. In phase 3 clinical trials of LEVEMIR®, antibody development has been observed with no apparent impact on glycemic control.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of LEVEMIR®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Medication errors have been reported during post-approval use of LEVEMIR® in which other insulins, particularly rapid-acting or short-acting insulins, have been accidentally administered instead of LEVEMIR® . To avoid medication errors between LEVEMIR® and other insulins, patients should be instructed always to verify the insulin label before each injection.

Read the entire FDA prescribing information for Levemir (Insulin Detemir)

Maintaining Weight Loss While Taking Insulin

Q1. I may need to start taking insulin, but I’ve just successfully lost 60 pounds. Will insulin cause me to gain the weight back?

Yes, it is possible that insulin can cause weight gain, although there are ways that you may be able to prevent it.

Let me begin with a few words about the relationship between insulin and weight gain. Insulin is usually prescribed to individuals whose glucose is not controlled by oral drugs. When blood sugar goes uncontrolled, individuals often lose weight. This happens even as they take in more calories due to the increased hunger that’s commonly associated with uncontrolled glucose. When someone loses weight because of uncontrolled glucose (and not because of diet and exercise) then they may gain the weight back once they begin regularly injecting insulin. This is because insulin helps the body use glucose more efficiently, so the body requires fewer calories to function. If these individuals continue to take in as many calories as they did before starting insulin, excess sugar that the body cannot burn will build up, and it will then be stored as fat.

Having said this, not all types of insulin are created equal. Certain types of insulin are more likely to lead to weight gain than others: NPH insulin causes more weight gain than Lantus, for example, and Lantus causes more weight gain than Levemir.

Now let’s look at ways you can prevent weight gain. First, make sure you are not consuming more calories than your body requires. You should consult a registered dietitian or use a Web-based calculator to figure out how many calories you require. This number usually reflects your need based on your current weight and your activity level. Once you figure out how many calories your body needs, try to consume that much and burn the excess calories through physical activity.

Second, avoid skipping meals. Missing meals can lead to low sugar levels, which might cause you to overcompensate by consuming more calories.

Third, discuss different medical options with your doctor, including whether you should:

  • Use a combination of treatments to help maintain your weight. For example, Glucophage (metformin) helps people with diabetes maintain their weight and — if used with insulin — limits the weight they gain. Rapid-acting oral medicines such as Prandin (repaglinide), which are taken before meals to help regulate blood-glucose levels, also aid in the prevention of insulin-associated weight gain.
  • Take Levemir or Lantus instead of NPH.
  • Avoid the use of thiazolidinediones (Avandia or Actos) with insulin.

— Brenda, New Jersey

There are many causes of fatigue. In your case, the culprit might be your high sugar level. Uncontrolled diabetes deprives cells of needed fuel, and lack of sleep due to uncontrolled sugar can make you feel fatigued and sleepy during the day. You are already taking medicine, but your current regimen has not adequately controlled your sugar level. Therefore, I recommend that you discuss with your doctor additional medicines to better control your diabetes. In addition to this, you should exercise and stick to a diabetic diet. Exercise and healthy diet, in addition to controlling your sugar, will also boost your energy level. Increasing your fiber intake and adding protein to every meal will slow the absorption of carbs, thus reducing the sugar peaks after a meal and the fatigue associated with these peaks. If you are not engaged in any leisure-time physical activity now, consult your doctor to determine the level at which you should begin exercising.

Fatigue in diabetics can have other causes as well. Many individuals who have diabetes also have high blood pressure and tend to be overweight or obese. One of the few symptoms of uncontrolled blood pressure is fatigue. Obesity makes sugar control difficult, and is associated with another condition called obstructive sleep apnea that causes sleep disturbance, resulting in daytime fatigue and drowsiness. Fatigue is also one of the symptoms of thyroid dysfunction, heart disease, and other conditions. I suggest that you have a medical evaluation to determine the cause of your fatigue, in addition to taking the above measures to control your diabetes.

Q3. My mother had type 2 diabetes, and she was not overweight, yet there are so many overweight people who do not have diabetes. Why is this?

— Carmen, New York

Yes, your observation is accurate and reflects the complexity of diabetes and the problem with our current classification system. The simple classification system of diabetes as type 1 and 2 does not reflect the fact that diabetes is a collection of many different conditions that cause high levels of sugar in the blood stream. There are close to 30 defects and conditions associated with either insulin resistance or insulin deficiency, which are the two basic mechanisms for diabetes. A few of these defects are genetic or hormonal; others result from autoimmune disorders, viral infections, or injuries to the pancreas. While type 1 diabetes is caused by the antibody-mediated destruction (autoimmune disorders) of the pancreatic cells that produce insulin and usually occurs among infants and children, type 2 diabetes is commonly associated with insulin resistance and is diagnosed among adults. Having said this, there are a growing number of overweight and obese children who are developing type 2 diabetes and a few adults who have type 1 diabetes.

Let me define insulin resistance, which is linked to type 2 diabetes, and explain why weight is associated with it. Insulin resistance is a condition whereby the pancreas releases an adequate amount of insulin but the body’s organs, primarily the skeletal muscle, the liver and fat cells, do not respond to the insulin or utilize glucose normally. This causes sugar to accumulate in the blood stream, leading to the typically high levels we see in diabetics. Any number of the steps in the glucose metabolism (e.g. how the body burns sugar for energy) pathway may be the underlying cause of insulin resistance. Some of these are specific genetic defects but the more common cause is excessive weight. Excess fat in the body releases at least three different types of metabolic products, which cause insulin resistance. To make matters even more confusing, not everyone who has excess fat develops insulin resistance enough to cause diabetes.

Most overweight and mildly obese folks who go on to develop diabetes also have a family history of the disease or carry other risks such as advancing age, low birth weight or are subject to other environmental and yet undiscovered triggers. These factors usually lead to pancreatic dysfunction so that the pancreatic cells are not producing an adequate amount of insulin, enough to compensate for the insulin resistance. Family history of diabetes might skip a generation and the environmental conditions might not be detected.

In a nutshell, among many overweight individuals, diabetes is caused by a combination of factors, excess weight causing insulin resistance and other factors limiting the ability of the pancreas to compensate for the insulin resistance. Hence, not all overweight individuals develop diabetes. And because there are reasons other than excess weight to develop insulin resistance such as genetic defects as mentioned above, not all individuals who have diabetes are overweight.

Q4. My 43-year-old husband was diagnosed with type 2 diabetes this week. He weighed 249 pounds last November, and as of today, he is 181 pounds. I always associated the disease with weight gain, so I never guessed he had diabetes. I have two basic questions: Have we done any damage waiting so long for the diagnosis? This is all so overwhelming — where is the best place to start finding information? The Internet? Books? Thank you for your advice.

— Andrea, Indiana

A diagnosis of diabetes can be overwhelming for many reasons. It can be a frightening disease, which, if not managed well, can lead to life-threatening complications. Because diabetes involves something that is so basic to our existence — food — it can seem to control our lives. But the challenge — and your goal — is to take control of the disease instead.

Diabetes typically begins subtly. On average, it takes five years from onset to diagnosis. Most people who are diagnosed in the early stages find out incidentally, when they have their blood sugar checked for other reasons, but most diabetes-related symptoms, including weight loss, do not occur early on. I know it’s counterintuitive to think that one might lose weight as he or she is developing diabetes, but it is a time of great metabolic demand and fluid loss, and that can result in the loss of weight. The delay in diagnosis can be associated with some complications, such as early retinal (back of the eye) disease, but the good news is that with good sugar control, these complications can be prevented or managed.

A great deal of information about diabetes and its management is available. The first sources of information should be your husband’s doctor and the diabetes educator at your local health center or hospital. The Internet can also be a great source, but you must sift through the information carefully. One informative place to start is right here at EverydayHealth.com, in the Diabetes Center. You can also go to the American Diabetes Association’s Web site, as well as that of the American Dietetic Association, to find information relevant to you and your family. Many books are also available to the lay public that you might find helpful, including some written by individuals who live with diabetes. You can also read Diabetic Living magazine and visit its Web site.

If you decide to take any advice in the books or on the Web sites, I suggest you first consult your husband’s doctor to make sure the information is accurate and up to date.

Q5. I was recently diagnosed with type 2 diabetes. My first reaction was to drop the carbohydrates. I am overweight by 125 pounds, and I need to reduce that number right now. I have been following a low-carb diet for two weeks and have lost only 4 pounds. Is it okay for me to continue? My blood sugar readings have come down.

— Laura, Pennsylvania

It’s very good that you recognize the need to reduce your weight and are already shedding pounds. In fact, the rate at which you are losing weight is perfectly fine. I recommend losing 1 to 2 pounds per week. Doing so requires that you cut about 500 calories from your diet each day, or about 3,500 calories each week. This number can change as your body becomes more efficient at using and storing energy during your diet. In time, you will probably need to reduce your intake further or, preferably, burn more calories in order to achieve the same level of weight loss.

There is an ongoing debate about whether low-carbohydrate diets are superior to low-fat diets. In the short term, a low-carb diet leads to more weight loss, but in the long run, both low-carb and low-fat diets produce similar results. My concern with low-carb dieting is that it can eliminate or drastically reduce the intake of highly nutritious foods, including whole grains and fruits. And since we do not know the long-term effects of low-carb dieting, it is best to eat a balanced diet and reduce your total caloric intake by cutting down on both carbohydrates and fat. As you know, problems with fat and glucose metabolism tend to occur together; and adult diabetics usually have elevated levels of cholesterol and/or triglycerides. So reducing these fats in the diet has great benefits.

The bottom line is that reducing caloric intake for a long period of time — along with daily physical activity — will lead to weight loss and maintenance of weight loss.

Learn more in the Everyday Health Type 2 Diabetes Center.

Generic Name: insulin detemir

Medically reviewed by Drugs.com. Last updated on Jan 28, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

Note: This document contains side effect information about insulin detemir. Some of the dosage forms listed on this page may not apply to the brand name Levemir.

In Summary

Common side effects of Levemir include: severe hypoglycemia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to insulin detemir: subcutaneous solution

Along with its needed effects, insulin detemir (the active ingredient contained in Levemir) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking insulin detemir:

Incidence not known

  • Anxiety
  • blurred vision
  • chills
  • cold sweats
  • confusion
  • cool, pale skin
  • cough
  • depression
  • difficulty swallowing
  • dizziness
  • fast heartbeat
  • fever
  • headache
  • hives
  • hoarseness
  • increased hunger
  • irritation
  • itching
  • joint pain
  • nausea
  • nightmares
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • seizures
  • shakiness
  • skin rash
  • slurred speech
  • stiffness or swelling
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • trouble breathing
  • unusual tiredness or weakness

Some side effects of insulin detemir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • decrease in the amount of urine
  • noisy, rattling breathing
  • redistribution or accumulation of body fat
  • swelling of the fingers, hands, feet, or lower legs
  • trouble breathing at rest
  • weight gain

For Healthcare Professionals

Applies to insulin detemir: subcutaneous solution

General

Adverse reactions associated with insulin detemir (the active ingredient contained in Levemir) include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, rash, and pruritus.

Metabolic

Severe hypoglycemia defined as third party intervention, occurred in approximately 6% of patients receiving insulin detemir (the active ingredient contained in Levemir) in clinical trials. Weight gain has been reported with insulin therapy and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.

Very common (10% or more): Hypoglycemia

Frequency not reported: Weight gain

Local

Injection site reactions seem to occur more frequently with insulin detemir (the active ingredient contained in Levemir) than with human insulin products. Reactions have included pain, redness, hives, inflammation, bruising, swelling, and itching at the injection site. Most injection site reactions have been minor and transitory, disappearing in a few days to a few weeks, even with continued treatment.

Common (1% to 10%): Injection site reactions

Uncommon (0.1% to 1%): Injection site pain

Hypersensitivity

Hypersensitivity side effects have included both local and systemic reactions. Anaphylaxis has been reported. Local reactions have presented as erythema, local edema, and pruritus at the injection site. Most minor reactions to insulin at the injection site resolve in a few days to a few weeks.

Allergic reactions and potentially allergic reactions were reported more frequently in 3 clinical studies with subjects receiving combination oral antidiabetic agents compared with the frequency across all studies (2.2% versus 0.1% to 1%).

Uncommon (0.1% to 1%): Allergic reactions

Cardiovascular

Uncommon (0.1% to 1%): Peripheral edema

Insulin may cause sodium retention and edema, especially as metabolic control is improving.

Ocular

Frequency not reported: Refraction disorder, worsening of diabetic retinopathy

Rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder and worsening of diabetic retinopathy. However, long-term glycemic control decreases the risk of diabetic retinopathy.

Dermatologic

Common (1% to 10%): Lipohypertrophy

Uncommon (0.1% to 1%): Lipoatrophy

Postmarketing reports: Rash urticaria

Immunologic

In phase 3 trials, antibody development with no apparent impact on glycemic control was observed.

Very common (10% or more): Influenza-like illness (up to 13%)

Common (1% to 10%): Viral infection

Frequency not reported: Antibody development

Other

Common (1% to 10%): Pyrexia, fatigue

Gastrointestinal

Very common (10% or more): Gastroenteritis (up to 16%), abdominal pain (up to 13%)

Common (1% to 10%): Nausea, vomiting, toothache

Genitourinary

Common (1% to 10%): Urinary tract infection

Nervous system

Rapid improvement in glucose control has been associated with a transitory, reversible acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk.

Very common (10% or more): Headache (up to 31%)

Common (1% to 10%): Migraine, dizziness

Rare (less than 0.1%): Painful peripheral neuropathy

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 35%), pharyngitis (up to 17%)

Common (1% to 10%): Bronchitis, cough, rhinitis, sinusitis

1. “Product Information. Levemir (insulin detemir).” Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

2. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

3. Cerner Multum, Inc. “Australian Product Information.” O 0

4. “Multum Information Services, Inc. Expert Review Panel”

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Related questions

  • Which type of insulin has the longest duration of action?
  • Levemir vs Lantus: What’s the Difference?

Medical Disclaimer

More about Levemir (insulin detemir)

  • During Pregnancy
  • Dosage Information
  • Drug Interactions
  • Compare Alternatives
  • Support Group
  • Pricing & Coupons
  • 28 Reviews
  • Drug class: insulin
  • FDA Alerts (3)
  • FDA Approval History

Consumer resources

  • Levemir
  • Levemir FlexPen
  • Levemir (Advanced Reading)
  • Levemir Flexpen (Advanced Reading)

Professional resources

  • Levemir (AHFS Monograph)
  • … +1 more

Related treatment guides

  • Diabetes, Type 2
  • Diabetes, Type 1

Levemir Flextouch

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Insulin is injected under the skin. You will be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

If you use this medicine once daily, use the injection at your evening meal or at bedtime. If you use the medicine twice daily, use your evening dose at least 12 hours after your morning dose.

Your care provider will show you the best places on your body to inject insulin detemir. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Your doctor may want you to use a short-acting insulin in addition to insulin detemir. Always inject your insulins separately. Insulin detemir must not be given with an insulin pump, or mixed with other insulins. Do not inject insulin detemir into a vein or a muscle.

If you use an injection pen, use only the injection pen that comes with insulin detemir. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share an injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your insulin dose or schedule.

Insulin detemir is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) insulin detemir:

  • Refrigerate and use until expiration date; or
  • Store at room temperature and use within 42 days.

Storing opened (in use) insulin detemir:

  • Store the vial in a refrigerator or at room temperature and use within 42 days.
  • Store the injection pen at room temperature (do not refrigerate) and use within 42 days. Do not store the injection pen with a needle attached.

Do not use the medicine if it looks cloudy or has changed colors. Call your pharmacist for new medicine.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Wear a diabetes medical alert tag in case of emergency. Any medical care provider who treats you should know that you have diabetes.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

Call your doctor for instructions if you miss a dose of insulin detemir. Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

Copyright 1996-2020 Cerner Multum, Inc.

Latest Update: 11/9/2018, Version: 8.02

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