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Is Levemir Safe For Pregnancy

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 >>

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® — 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 >>

Levemir And Pregnancy?

Levemir And Pregnancy?

Registration is fast, simple and absolutely free so please,join our community todayto contribute and support the site. This topic is now archived and is closed to further replies. I am a type 2 diabetic who has raised sugars in the am. I have been put on levemir and it's done wonders for me! I use to wake up to 11-13 sugars every morning no matter what I did/ate the night before and now I wake up with 6-7's. I have just turned 42 and wanting to do IVF in November but have been told by my endocrinologist that levemir has not been tested so I will have to go on N and R again. I am also on gluconorm and metformin. In the past, my body has disagreed with the two insulins causing bloating, wait gain and many low sugars. Does anyone else currently use levemir and pregnant or planning to get pregnant? i'm planning a pregnancy and am on N. same thing here...my endo so far won't prescribe levemir or lantus because of that. i'm going to press and press though and see what happens. i am using humalog though, not regular, for bolus. ellement- you're doing great with your AIC's - good job! It's funny she told me there hasn't been enough research on the levemir, yet she prescribed Junuvia without a blink of an eye and all I hear about that med is negative stuff relating to cancer! I'm on Levemir for pregnancy. I had to fight my endocrinologist to stay on it when I became pregnant though lol . Actually my endocrinologist wouldn't give me a Lev prescription so I went to see another doctor who i didn't tell I was planning to get pregnant that I wanted to try Levemir. He only found out afterwards and said it was fine that there was no evidence saying Levemir was bad for pregnancy. I am glad that I have been on Levemir for the pregnancy as my endocrinologist has informed me that a few wo Continue reading >>

Insulin Glargine Safety In Pregnancy

Insulin Glargine Safety In Pregnancy

Go to: Abstract Insulin glargine (Lantus) is an extended-action insulin analog with greater stability and duration of action than regular human insulin. The long duration of action and decreased incidence of hypoglycemia provide potential advantages for its use in pregnancy. However, the placental pharmacokinetics of insulin glargine have not been studied. Therefore, the objective of this study was to determine whether insulin glargine crosses the human placenta using the human perfused placental lobule technique. Placentae were obtained with informed consent after elective cesarean section delivery of noncomplicated term pregnancies. Insulin glargine, at a therapeutic concentration of 150 pmol/l (20 μU/ml) was added to the maternal circulation. Additional experiments were carried out at insulin glargine concentrations 1,000-fold higher than therapeutic levels (150, 225, and 300 nmol/l). A subsequent perfusion for which the maternal circuit remained open and insulin glargine was continuously infused at 150 pmol/l was completed for further confirmation of findings. The appearance of insulin glargine in the fetal circulation was analyzed by a chemiluminescence immunoassay. Results from perfusions carried out at therapeutic concentrations (150 pmol/l) of insulin glargine showed no detectable insulin glargine in the fetal circuit. After perfusion with very high insulin glargine concentrations of 150, 225, and 300 nmol/l, the rate of transfer remained low at 0.079 ± 0.01, 0.14, and 0.064 pmol · min−1 · g tissue−1, respectively. Maternal to fetal transport of insulin glargine Experiment no. Maternal concentration (pmol/l) Lobule weight (g) Fetal concentration (pmol/l) Rate of transfer (pmol · min−1 · g tissue−1) 1 150 15.17 Below LOQ — 2 150 9.8 Below LOQ — Continue reading >>

Another Insulin Choice Approved For Pregnant Women

Another Insulin Choice Approved For Pregnant Women

For years NPH (neutral protamine hagedorn) also known as Humilin N® or Novolin N® was the only basal (longer acting) insulin approved to control glucose levels in pregnant women. Now the Food and Drug administration (FDA) has given the go ahead to revising the drug classification for Levemir® (insulin detemir), giving health care providers and patients another insulin choice. NPH is an intermediate acting insulin that begins working in 90 minutes to 4 hours, peaks between 4 to 12 hours and has an overall duration of 24 hours (although practically lasts about 16 to18 hours). Because it is a human insulin with the same amino acid structure as the insulin in our bodies, it is considered safe for use in pregnancy. Women with diabetes prior to beginning pregnancy usually take two injections per day, while those who contract gestational diabetes can often achieve metabolic control with one injection in the evening. Although effective, NPH has a number of drawbacks that have reduced its use as insulin-of-choice for the general population. Its action time is quite variable from day to day, which can make it difficult to achieve optimal glucose control. So even if activity and food intake is controlled for, significant blood glucose fluctuations can still occur. And unlike today’s more common basil insulins, NPH has a peak or extra punch hours after injection. Often this requires that patients eat a snack to avoid the possibility of low blood glucose. Levemir®, on the other hand, offers the possibility of one injection per day and avoids the issue of timing for snacks. Pregnant women with diabetes, unlike the general adult population with diabetes, still need snacks in order to consume adequate carbohydrate and protein for fetal growth. And unlike NPH, it has a more consis Continue reading >>

Levemir And Pregnancy

Levemir And Pregnancy

It is generally considered safe to take Levemir (insulin detemir) during pregnancy. In human studies, the medication did not appear to increase the risk of birth defects. If you are using Levemir during pregnancy, talk to your healthcare provider about your insulin requirements, as they may change during the course of your pregnancy. Levemir ( insulin detemir ) is a prescription diabetes medication used to treat type 1 and type 2 diabetes . It is a long-acting form of insulin . Based on the available animal and human data, the drug appears to be safe for use during pregnancy. The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category B is given to medicines that have not been adequately studied in pregnant humans but do not appear to cause harm to the fetus in animal studies. Medications that have been shown to be safe for use in pregnancy in humans (but have caused problems in laboratory animals) are also given a Category B rating. In animal studies, Levemir increased the risk of various birth defects. However, in these studies, regular human insulin also increased the risk of birth defects, and it appears that Levemir is probably as safe as regular human insulin -- at least in animals. 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 >>

Levemir And Getting Pregnant

Levemir And Getting Pregnant

Diabetes Forum The Global Diabetes Community Find support, ask questions and share your experiences. Join the community I have Type 1 for 19yrs already and I'm planning getting pregnant. I take Humalog and Levemir and my diabetologist doesn't want to change Levemir for other shorter acting insulin. Has anyone been taking Levemir being pregnant (as it is not clinically tested on pregnant women and studies on animals show embryo malformations)?? What are your views on this? Hi, this is a very good question. I was taken off novorapid and put on to humalog when I got pregnant 9 years ago. Still worry about it, as I no longer trust any synthetic insulin. I'm quite sure it's also not recommended to take Lantus in pregnancy. Purified animal insulins has been tried and tested for years and years, synthetic 'human' insulins only came about in the 80s, and the analogues in last 10 years or so. I know what I would trust, and in retrospect I would much rather have been educated about what I was taking for my diabetes. I just trusted the doctors. I was on synthetic insulins for 19 years until, due to ill health and poor blood sugar control, I changed to hypurin porcine insulin a year ago. Life has improved for me beyond belief! You should do some internet research on synthetic and purified animal insulins. Not just for the sake of a safe pregnancy but for your own health. The truth is because these 'analogue' insulins suchas Novorapid, Humalog, Lantus, and Levemir have only been available for a limited time, no-one really knows the long-term effects on us, let alone our children. You are obviously concerned and wise to be so, and not to take your doctor's word. Can u tell me where you got info bout the embryo malformation? I was swapped from apidra to novorapid (but i was told that 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 >>

Metformin And Insulin For The Treatment Of Gestational Diabetes

Metformin And Insulin For The Treatment Of Gestational Diabetes

Metformin and insulin for the treatment of gestational diabetes Glibenclamide, metformin, and insulin for the treatment of gestational diabetes: a systematic review and meta-analysis BMJ 2015; 350 doi: (Published 21 January 2015) Cite this as: BMJ 2015;350:h102 Metformin and insulin for the treatment of gestational diabetes Gestational diabetes complicates around 5% of pregnancies and its incidence is on rise. Gestational diabetes is associated with increased complications during pregnancy. It is also associated with long-term risk of diabetes in both mother and offspring.1,2 Insulin is used as first line drug in gestational diabetes treatment. Insulin is classified as FDA category B drug means animal reproduction studies have failed to demonstrate a risk to the foetus and there are no adequate and well-controlled studies in pregnant women. FDA approved metformin in year 1994 long after it was approved in many countries for the treatment of type 2 diabetes. Metformin has also been used extensively in patients of infertility with PCOS; as a result many patients continued it inadvertently in first trimester of pregnancy therefore having large safety data in pregnancy. Metformin too categorized as US FDA pregnancy category B, at par with insulin. Recently FDA approved insulin detemir (Levemir, Novo Nordisk) with pregnancy Category B classification. Previously, Levemir was relegated to pregnancy category C, meaning animal reproductive studies has shown an adverse effect on the fetus and adequate and well-controlled studies in humans were not available. FDA changed Levemirs status after receiving a new randomized, controlled trial of 310 pregnant women with type 1 diabetes. The study compared the safety and efficacy of Levemir against NPH insulin. Insulin is a big market wi 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 >>

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 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 >>

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 >>

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