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Levemir And Pregnancy

Levemir® — The First Basal Insulin Analog With Pregnancy Category B Classification.1

Levemir® — The First Basal Insulin Analog With Pregnancy Category B Classification.1

Levemir® is the first FDA-approved basal insulin analog with Pregnancy Category B classification. In a randomized, controlled clinical trial1: Pregnant women with type 1 diabetes (n=310) were treated with either Levemir® (n=152) or NPH insulin (n=158) in a basal-bolus regimena Women were randomized either as pregnant or planning pregnancy; those who where randomized as pregnant were between weeks 8 and 12 of gestationb Approximately one-half of the study participants in each arm were randomized as pregnant and were exposed to NPH insulin or other insulins prior to conception and in the first 8 weeks of gestation According to pretrial insulin regimen: Levemir® was administered once or twice daily NPH was administered once, twice, or 3 times a day An open-label, randomized, parallel-group, multinational study in women with type 1 diabetes who were on insulin for at least 12 months before randomization and who were planning to become pregnant or already pregnant at gestational weeks (GWs) 8 to 12. Patients could enroll in the study with intention to become pregnant. Patients were withdrawn from the trial if they did not become pregnant within 1 year. Patients were separated at randomization as pregnant and nonpregnant and all were required to have A1C ≤8% at confirmation of pregnancy. Patients were randomized 1:1 to Levemir® (n=152) or NPH insulin (n=158). Both groups used NovoLog® (insulin aspart injection) 100 U/mL as mealtime insulin. Approximately 50% of the women also received Levemir® or NPH insulin prior to conception and in the first 8 weeks of gestation. Regimen was followed from randomization until termination/6 weeks postdelivery.2 Adapted from Mathiesen et al, 2012.2 aBoth groups used NovoLog® (insulin aspart injection) 100 U/mL as mealtime insulin. bP Continue reading >>

Using Insulin In Pregnancy: Fda Approves Levemir

Using Insulin In Pregnancy: Fda Approves Levemir

Novo Nordisk’s Levemir (insulin detemir) has been classified as Category B for pregnant women. “This is the most thrilling news since the discovery of insulin,” says Dr. Lois Jovanovic, CEO and Chief Scientific Officer of the Sansum Diabetes Research Institute and world-renowned expert in diabetes and pregnancy. “I am thrilled.” Given that Dr. Jovanovic is so unequivocally positive, the news deserves a bit more explanation for those of us who aren’t experts and aren’t pregnant. Levemir is the first long-acting insulin other than NPH to be classified as Category B. But what exactly does that mean? And why are we so worried about insulin in pregnancy anyway? The FDA, Dr. Jovanovic explains, needs to make sure drugs taken by women during pregnancy are safe for the baby, and not going to cause any birth defects or abnormalities. The FDA therefore assigns drugs to a category that indicates how they should be used in pregnancy. Category A drugs are things like vitamins—not just okay to use, but actually good for the pregnant woman and the fetus. Category B drugs are not necessarily positive for pregnancy, but all animal and human studies must indicate that the drug is safe for the mother and the baby. Category C drugs are not known to cause birth defects, but have not been sufficiently tested in humans to really be certainly safe. Up until now, untested insulin analogues, and all long-acting insulin analogues other than NPH, fell into Category C—not known to be harmful, but not known to be safe either. Now, normal, non-diabetic women produce their own insulin, and that insulin is obviously safe for fetuses. What, then, makes insulin analogues different and riskier? The answer is that insulin analogues may behave similarly to human insulin in the body, but th Continue reading >>

Levemir Pregnancy Category Change

Levemir Pregnancy Category Change

LEVEMIR (insulin detemir [rDNA origin]) 100 Units/mL by Novo Nordisk Novo Nordisk announced that the FDA has approved Levemir (insulin detemir [rDNA origin] injection) for a pregnancy Category B classification, indicating that when used in pregnant women with diabetes, Levemir does not increase the risk of harm to the unborn baby. The new label update makes Levemir the first and only basal insulin analog to have this classification. NPH (human insulin) was considered the standard of care for diabetes in pregnancy up until this decision. The FDA category change was based on a review of a large, randomized controlled trial examining the safety and efficacy of Levemir in 310 pregnant women with type 1 diabetes against NPH insulin. The study found that patients taking Levemir had similar A1C reduction at gestational week 36 and lower fasting plasma glucose levels at gestational weeks 24 and 36 compared with NPH. Additionally, the study found no differences in the overall safety profile during pregnancy, on pregnancy outcomes or the health of the fetus and newborn. Levemir is a man-made long-acting insulin indicated to treat type 1 diabetes (in adults and children) and type 2 diabetes (in adults) when basal insulin is needed. For more information call (800) 727-6500 or visit www.levemir-us.com . Continue reading >>

Insulin Detemir (levemir) Use During Pregnancy

Insulin Detemir (levemir) Use During Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetusAU TGA pregnancy category: B3US FDA pregnancy category: B Pregnancies complicated by hyperglycemia pose an increased risk of birth defects, pregnancy loss, or other adverse events. In an open-label randomized trial in pregnant women with type 1 diabetes using basal bolus regimens of insulin detemir (n=152) or NPH insulin (n=158), no increase in fetal abnormalities were observed in the insulin detemir arm. In animal studies in rats and rabbits, the embryotoxicity and teratogenicity of insulin detemir did not differ greatly from that observed with human insulin. Patients with diabetes or a history of gestational diabetes should maintain good metabolic control before conception and during pregnancy. Insulin requirements may decrease during the first trimester; generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential.AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Exogenous insulins, including the newer biosynthetic insulins (i.e. aspart, detemir, glargine, glulisine, lispro) appear to be excreted into breast milk. Insulin is a protein that is inactivated if taken Continue reading >>

Fda: Levemir Insulin Now Safe For Pregnancy

Fda: Levemir Insulin Now Safe For Pregnancy

To maximize the chances of having a healthy baby, women who are pregnant with pre-existing diabetes need to keep very tight control of their blood sugar levels. To do so, many begin taking insulin, sometimes for the first time if they are type 2, before or early into their pregnancies. Now there's a new option for those who inject. Levemir, an insulin that works to keep blood sugars steady for up to 24 hours at a time, was recently approved by the United States Food and Drug Association (FDA) as a category B medication. The insulin, also known by its generic name detemir, is the first basal (long-acting) insulin to receive this approval; category B drugs are those that do not increase the risk of harm to a growing fetus. According to a press release, the FDA category change was based on a review of a large, randomized controlled trial of 310 pregnant women who used either Levemir or NPH insulin. The study found that those who took Levemir had similar A1C levels at gestational week 36 and lower fasting blood glucose levels at gestational weeks 24 and 36, compared with NPH. Additionally, Levemir was considered safe for the women, both during pregnancy as well as after delivery, both for mother and child. The research is pending acceptance for publication, but was presented in 2011 at the American Diabetes Association's 71st annual Scientific Sessions. "The approval of insulin detemir is the best advance that has happened for the field of diabetes and pregnancy since the discovery of insulin," said Dr. Lois Jovanovic, MD, MACE, the Chief Scientific Officer of the Sansum Diabetes Research Institute in Santa Barbara, California. Levemir, manufactured by Novo Nordisk, begins working in the body 2-4 hours after injection, and doesn't peak. It provides a steady dose of long-act Continue reading >>

Management Of Diabetes During Pregnancy

Management Of Diabetes During Pregnancy

Selected Important Safety Information Contraindications Levemir® is contraindicated in patients with hypersensitivity to Levemir® or any of its excipients. Warnings and Precautions Never Share a Levemir® FlexTouch® Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens. Dosage adjustment and monitoring: Monitor blood glucose in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment of concomitant anti-diabetic treatment. Administration: Do not dilute or mix with any other insulin or solution. Do not administer subcutaneously via an insulin pump, intramuscularly, or intravenously because severe hypoglycemia can occur. Indications and Usage Levemir® (insulin detemir [rDNA origin] injection) is indicated to improve glycemic control in adults and children with diabetes mellitus. Important Limitations of Use Levemir® is not recommended for the treatment of diabetic ketoacidosis. Intravenous rapid-acting or short-acting insulin is the preferred treatment for this condition. Important Safety Information (cont'd) Contraindications Levemir® is contraindicated in patients with hypersensitivity to Levemir® or any of its excipients. Warnings and Precautions Never Share a Levemir® FlexTouch® Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens. Dosage adjustment and monitoring: Monitor blood glucose in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision. Changes in insulin strength, manufac Continue reading >>

Levemir During Pregnancy Help!!

Levemir During Pregnancy Help!!

Diabetes Forum The Global Diabetes Community Find support, ask questions and share your experiences. Join the community Just wondering if anyone here has used levemir during pregnancy? I am currently using Levemir and Novorapid and after much hard work have finally reached a HBA1C of 6.4 which am very pleased with and after many years of it only being a dream I am hoping to be able to try to become pregnant. Now my nurse has told me I must change to Humulin whilst trying and if I become pregnant. I am so worried and upset now and don't want to upset my good control by changing. Can anyone relate to this? If so please let me know. Ciongratulations on the HBA1c. I am currently 22 weeks pregnant with my second child, and during this pregnancy, and my last, was on, guess what...novorapid and levimir. Here is what I was told. There has been no research on levimir in pregnancy...I think the same applies to many of the newer type insulins. However, my consulant felt, and I agree, which is why I am doing what I am doing, that my diabetes control was more important to the baby and my health, than upsetting the insulin regime I had worked so hard to get right and is working for me. The only thing I can tell you for sure is that you should smile at your nurse, and ask if she can help you get reffered to the maternity unit at your local hospital. There, I am almost sure, you will be able to talk to experts in diabtic pregnancy. At my local hospital, they have a diabetic midwife, who will be able to give you excellent advice. I would seriously change nothing until you do this! Phone up/look on the website at the hospital you want to give birth at (scary thought I know!!!) and usually there will be the details of who to contact. Most offer a pre pregnancy service...which is sounds l Continue reading >>

Fda Approves Levemir® Pregnancy Category Change For Women With Diabetes

Fda Approves Levemir® Pregnancy Category Change For Women With Diabetes

Levemir® is the first and only basal insulin analog with pregnancy Category B classification ® (insulin detemir [rDNA origin] injection) for a pregnancy Category B classification, indicating that Levemir®, when used in pregnant women with diabetes, did not increase the risk of harm to the unborn baby. To view the multimedia assets associated with this release, please click: (Photo: ) The label update makes Levemir® the first and only basal insulin analog to have this classification. Until this decision, NPH (human insulin) was considered the standard of care for diabetes in pregnancy. Now, Novo Nordisk is the only company that offers a complete portfolio of insulin analogs with a pregnancy Category B classification. The FDA category change was based on a review of a large, randomized controlled trial examining Levemir® in pregnant women with type 1 diabetes. The study compared the safety and efficacy of Levemir® against NPH insulin in the treatment of 310 women. The study found that patients taking Levemir® had similar A1C reduction at gestational week 36 and lower fasting plasma glucose levels at gestational weeks 24 and 36 compared with NPH. Additionally, the study found no differences in the overall safety profile during pregnancy, on pregnancy outcomes or the health of the fetus and newborn. "We are excited that the FDA has granted approval for this new category rating for Levemir®," said Lois Jovanovic, MD, MACE, Chief Scientific Officer, Sansum Diabetes Research Institute in Santa Barbara, California. "For women who are pregnant, diabetes can be extremely challenging; they must be even more diligent and careful when monitoring blood sugar levels than before they were pregnant. This approval provides patients with a long-acting insulin analog option that ca Continue reading >>

Glycemic Control Using Insulin Levemir Versus Insulin Nph For Diabetes In Pregnancy

Glycemic Control Using Insulin Levemir Versus Insulin Nph For Diabetes In Pregnancy

You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Glycemic Control Using Insulin Levemir Versus Insulin NPH for Diabetes in Pregnancy The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov Identifier: NCT01837680 Information provided by (Responsible Party): Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information The aim of this study is to compare glycemic control in pregnant women treated with insulin Detemir and pregnant women treated with NPH insulin. These women are diagnosed with gestational diabetes (GDM) in the current pregnancy or have a preexisting diagnosis of type 2 diabetes (T2DM) at the onset of pregnancy. Our hypothesis is that there is no difference between these two treatment modalities in terms of glycemic control in diabetes. The experimental method will be a randomized controlled trial performed at Roosevelt Hospital in our Diabetes in Pregnancy Program (DIPP). Perinatologists managing the patient in DIPP determine when patients need further treatment with medical therapy. Patients undergoing care at DIPP may require medical intervention in the following clinical scenarios: failure of diet alone to control glycemic indices and grossly abnormal glucose tolerance screening test results suggesting disease of such severity that diet alone would not be sufficient. After verbally counseling the patient, she will be recruited for the study by the investigators. An extensive explanation of the objectives of the study will be present Continue reading >>

Levemir Overview

Levemir Overview

Levemir is a prescription medication used to treat type 1 and type 2 diabetes. Levemir, a long-acting form of insulin, works by replacing the insulin that is normally produced by the body and by helping the body to use sugar for energy. It also stops the liver from producing more sugar. This medication comes in an injectable form and is typically injected under the skin once or twice daily. Common side effects include redness and skin thickening at the injection site, weight gain, and constipation. Levemir is a man-made long-acting insulin that is used to control high blood sugar in adults and children with type 1 and type 2 diabetes. This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. Levemir may cause serious side effects. See "Drug Precautions" section. Common side effects of Levemir include: Low blood sugar (hypoglycemia) Reactions at the injection site (local allergic reaction). You may get redness, swelling, and itching at the injection site. If you keep having skin reactions or they are serious, talk to your doctor. Weight gain. This can occur with any insulin therapy. Talk to your doctor about how Levemir can affect your weight. Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects from Levemir. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalap Continue reading >>

Insulin Detemir In Pregnancy: A Small But Significant Step Forward?

Insulin Detemir In Pregnancy: A Small But Significant Step Forward?

Insulin Detemir in Pregnancy: A Small but Significant Step Forward? Discipline of Medicine, Sydney University, Sydney, New South Wales, Australia, and the Northern Sydney Endocrine Centre, St Leonards, New South Wales, Australia Corresponding author: Aidan McElduff, [email protected] . Author information Copyright and License information Disclaimer Copyright 2012 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See for details. See " Maternal Efficacy and Safety Outcomes in a Randomized, Controlled Trial Comparing Insulin Detemir With NPH Insulin in 310 Pregnant Women With Type 1 Diabetes " onpage2012. Pregnancies complicated by diabetes are at increased risk of adverse fetal and maternal outcomes and longer-term health problems in the offspring. Treatments directed at improving glycemic control reduce these risks. However, observational studies show that pregnancies complicated by either type 1 or type 2 diabetes, compared with nondiabetic pregnancies, still have more adverse outcomes, including increased perinatal mortality ( 1 , 2 ). The recent Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study ( 3 ) has established a continuum of risk between glycemic levels obtained during a glucose tolerance test and a variety of adverse fetal and maternal outcomes. Two large randomized controlled trials ( 4 , 5 ) of women with gestational diabetes mellitus, variously diagnosed, have demonstrated that treating and reducing glucose levels during pregnancy reduces many of these complications. The poor fetal outcomes in preexisting diabetes are largely related to the degree of maternal glycemic control. This is very well documented for the Continue reading >>

Levemir Approved For Use In Pregnant Women With Diabetes

Levemir Approved For Use In Pregnant Women With Diabetes

Levemir Approved for Use in Pregnant Women with Diabetes We are encouraged to report that the FDA has approved Levemir for use in pregnant women with type 1, type 2, or gestational diabetes. Levemir is a long acting, or basal insulin analog made by Novo Nordisk. The FDA approval was based on a study that showed that Levemir is safe to use in pregnant women and does not appear to be associated with a risk of birth abnormalities. Both the study and the decision are important steps forward in helping women manage their diabetes during pregnancy . Strict glycemic control is especially important during pregnancy because abnormal glucose levels increase the risk of miscarriages and complications for the mother as well as birth defects and low birth weight for the infant. Currently, most women without an insulin pump use NPH (intermediate-acting human insulin), which is usually taken twice a day. Since Levemir is a steadier and longer-acting insulin treatment, it is sometimes taken only once a day, though some also take it twice daily. The insulin has also been associated with a smaller risk of hypoglycemia and may provide better glycemic control relative to NPH. We are eager to see how this more convenient and potentially more effective treatment will improve maternity care for US women who get pregnant each year and either have or get diabetes. NR Continue reading >>

Levemir Side Effects Center

Levemir Side Effects Center

Levemir (insulin detemir [rDNA origin] injection) is a man-made form of a hormone that is produced in the body used to treat diabetes in adults and children. Common side effects of Levemir include: injection site reactions (e.g., pain, redness, irritation), swelling of the hands/feet, thickening of the skin where you inject Levemir, weight gain, headache, back pain, stomach pain, flu symptoms, or cold symptoms such as stuffy nose, sneezing, sore throat. Tell your doctor if you experience serious side effects of Levemir including: signs of low potassium level in the blood (such as muscle cramps, weakness, or irregular heartbeat). Levemir is for once- or twice-daily subcutaneous (under the skin) administration. Patients treated with Levemir once-daily should administer the dose with the evening meal or at bedtime. Patients requiring twice-daily dosing can administer the evening dose with the evening meal, at bedtime, or 12 hours after the morning dose. Levemir may interact with albuterol, clonidine, reserpine, guanethidine, or beta-blockers. Other medicines can increase or decrease the effects of insulin Levemir on lowering your blood sugar. Tell your doctor all prescription and over-the-counter medications you use. Tell your doctor if you are pregnant before using Levemir. Discuss a plan for managing your blood sugars with your doctor before you become pregnant. Your doctor may switch the type of insulin you use during pregnancy. It is not known if this medication passes into breast milk. Consult your doctor before breastfeeding. Insulin needs may change while breastfeeding. Our Levemir (insulin detemir [rDNA origin] injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. T Continue reading >>

Levemir Approved For Diabetes During Pregnancy, Usa

Levemir Approved For Diabetes During Pregnancy, Usa

The U.S. Food and Drug Administration (FDA) has just approved Levemir®, an insulin detemir [rDNA origin] injection, as the first and only basal insulin analog for Pregnancy Category B classification, which indicates that Levemir® does not pose a higher risk of harm for the unborn when used in pregnant women with diabetes. The drug is manufactured by Novo Nordisk. Until now, the standard of care for diabetes in pregnancy has consisted of NPH, i.e. human insulin, however this has now changed, with Novo Nordisk being the only company that is able to provide a complete portfolio of insulin analogs with Pregnancy Category B classification. FDA approval was granted following a review of a large, randomized controlled trial that involved 310 pregnant women with type 1 diabetes, which assessed Levemir's® safety and efficacy compared with NPH insulin. The results demonstrated that women who were administered with Levemir® had a comparable reduction in A1C at gestational week 36 and lower fasting plasma glucose levels at gestational weeks 24 and 36 than women who received NPH. The researchers noted no difference in results regarding Levemir's® overall safety profile during pregnancy, its outcomes or the health of the fetus and newborn. Lois Jovanovič, MD, MACE, Chief Scientific Officer at Sansum Diabetes Research Institute in Santa Barbara, California remarked: "It is exciting that the FDA has granted approval for this new category rating for Levemir®. For women who are pregnant, diabetes can be extremely challenging; they must be even more diligent and careful when monitoring blood sugar levels than before they were pregnant. This approval provides patients with a long-acting insulin analog option that can help them manage their blood sugar." About 1.85 million women of c Continue reading >>

Insulin Use In Pregnancy: An Update

Insulin Use In Pregnancy: An Update

As of June 2015 in the United States, 2.7% of women who are 18–44 years of age have a diagnosis of type 1 or type 2 diabetes (1). About 5% of all diagnosed diabetes is type 1 diabetes, and 90–95% is type 2 diabetes. It is projected that, by 2050, one in three people will have some type of diabetes. An estimated 5,000 new cases of type 2 diabetes will be diagnosed annually in American children <20 years of age (2). Gestational diabetes mellitus (GDM) could affect up to 8.7% of all pregnancies in the United States (3). The Centers for Disease Control and Prevention reports that these numbers are still on the rise (2). As the age of diabetes diagnosis decreases in U.S. youth, the prevalence of pregestational diabetes is likely to increase in the pregnant population. Maternal diabetes causes complications in the embryo/fetus that start in the uterus, are present immediately after birth, and could potentially last a lifetime. Women with type 1 diabetes or type 2 diabetes diagnosed before or during the first trimester of pregnancy are at the greatest risk for fetal congenital anomalies and spontaneous abortions. This risk is associated with both frequent and severe hyperglycemia before conception and during organogenesis (5–8 weeks after the last menstrual period) (4,5). The more severe the maternal hyperglycemia, the greater is the risk for fetal abnormalities. Structural anomalies are a common result, with ∼37% of these affecting the cardiovascular system, 20% affecting the central nervous system, and 14% affecting the urogenital system (6). GDM develops and is diagnosed later in pregnancy, at 24–28 weeks’ gestation, when impaired glucose tolerance is detectable. Therefore, women with GDM are most likely euglycemic during organogenesis and have a decreased risk Continue reading >>

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