Statement #1
People with preexisting diabetes or gestational diabetes need to have a choice in what therapy they use for their diabetes and blood sugar management during a very vulnerable time in their lives. The decision to stop production of Levemir insulin has taken away a proven effective and safe insulin during pregnancy and should be reconsidered to allow patients and their providers to continue to provide the best care possible during pregnancy.
Statement #2
I am a Maternal Fetal Medicine physician for 40 years. Helping women with diabetes have a healthy pregnancy in the past decade has been made possible through the efforts of medications such as Levemir. Maintaining a healthy glucose/sugar level has been made possible through the use of medications such as Levemir. Keeping sugar levels in pregnancy in the normal range has not only short term benefits for the mothers but also has long term benefits for the offspring. If you are interested in not only short term treatments but long term prevention of health issues for the next generation, then please reconsider keeping Levemir available for pregnant women.
Statement #3
Levemir is a critical therapeutic option for pregnant individuals, and it has been a trusted therapy for years. There are many women who cannot tolerate insulin glargine for a number of different reasons, and the loss of Levemir leaves us without a viable option. NPH has a defined peak, and we often encounter issues with overnight hyperglycemia when we try to treat the elevated fasting glucose values that are so common in pregnancy. Although there is limited data regarding degludec use in pregnancy, the available studies were not adequately powered to show differences in maternal and fetal outcomes. Thank you for your consideration.
Statement #4
Pregnancy is a challenging life stage for people with diabetes because of the dynamic metabolic adaptation that occurs. Therefore, it is essential to have various options of insulin types available for use to not only adapt to the metabolic demands but also give pregnant individuals the autonomy (busy schedules, juggling family/work/life, and changes in sleep, unexpected pregnancy complications, etc) and confidence over their diabetes care. Levemir, particularly in the first trimester when there is increased sensitivity for people with T1D can be very useful to adjust the day and night dosing of their long-acting insulin. Many of our people with gestational diabetes have only fasting hyperglycemia so the option is excellent to use at bedtime to not affect their daytime risk for hypoglycemia.
Statement #5
I strongly support ensuring the availability Detemir in United States given many pregnant patients with Type 1, Type 2 DM and GDM achieve optimal control on Detemir. Alternatively, Glargine and NPH have different pharmacokinetic properties than Determir and Degludec has a very long half-life which makes frequent up-titration of Degludec in pregnancy challenging and poses a significant risk of hypoglycemia immediately after delivery. For the benefit of many pregnant patients with diabetes in pregnancy, I fully support the efforts in ensuring that Detemir is available for pregnant patients given evidenced-based randomized controlled trials in pregnancy which strongly support its excellent efficacy and clinical use.
Statement #6
I am a board-certified endocrinologist with more than 20 years of practice experience. Levemir has a unique role for women who are dependent on insulin for diabetes in pregnancy. The other available basal insulins in the US have not been studied with the same rigor in pregnancy and have disadvantages due to long duration of action that could put pregnant women at risk because of the rapidly changing insulin needs in the various stages of pregnancy and post-partum. Please keep Levemir available in the US.
Statement #7
The use of detemir in pregnancy is supported by a robust randomized controlled trial (RCT) of glycemic, pregnancy, and neonatal outcomes. It has proven safety and efficacy. Detemir is preferentially used in pregnancy by experts over other basal insulins. This preference is in part a function of detemir’s pharmacokinetic characteristics, such as the relatively short half-life that allows for split dosing to help mitigate the morning glucose rise during pregnancy, and its faster metabolism which helps avoid hypoglycemia in the setting of a sudden reduction in insulin resistance post-partum. Other long-acting insulins have remaining questions about applicability of use in this population. A recent RCT of insulin degludec was not powered to detect a difference between treatments in the maternal safety and pregnancy outcomes and did not report on risk of post-partum hypoglycemia that would be expected with its long duration of action.
Statement #8
Levemir provides a specific advantage over other basal insulin options in that it does not have a dramatic peak and trough effect and that its duration of action in the body in pregnancy approximates 12 hours. For pregnant women, this pharmacokinetic profile is particularly useful for addressing overnight and fasting hyperglycemia without increasing the risk of late morning and early afternoon hypoglycemia due to ongoing basal insulin effect.
Statement #9
As a Certified Diabetes Care and Education Specialist who specializes in pregnancy, I am quite concerned about the discontinuation of Levemir. There are only two basal insulins that have been rigorously studied in pregnancy; Levemir and NPH. NPH is an outdated, inferior insulin which is quite problematic due to its strong peak, which frequently results in hypoglycemia. Long-acting insulin glargine (Lantus/Basaglar/Semglee) has not been studied in RCT's, and insulin degludec's (Tresiba) very long action, is problematic as insulin needs change rapidly during pregnancy. This could result in dangerous hypoglycemic episodes. A more flexible option is needed, which is insulin detemir (Levemir). Pregnant people who use insulin are being forced to either suboptimal control, or an insulin pump. Not all patients can afford an insulin pump. Prenatal outcomes will be negatively affected by this discontinuation.
Statement #10
The discontinuation of Levemir comes at great cost to our pregnant patients. Levemir is the only long-acting insulin that has had randomized controlled trials conducted in pregnant women, and for some time has been recognized as the safest insulin option for pregnant patients. It is the only FDA approved basal insulin for pregnancy. Additionally, discontinuing Levemir without a biosimilar (detemir) leaves no option for patients who are intolerant to insulin glargine. We would ask that you reconsider discontinuation until another biosimilar is made available. We want to keep our most vulnerable populations safe, especially in the context of rising maternal and infant mortality in the US.
Statement # 11
Levemir® is one of the most used formulations in pregnancy given its maternal and fetal safety profile. Data from clinical trials demonstrated lower rates of severe hypoglycemia with insulin Levemir® compared to NPH in pregnant individuals with type 1 diabetes. Levemir’s pharmacologic properties makes it ideal to match the varying basal needs in pregnancy. The twice daily dosing allows for the flexibility to match the bifurcated insulin needs during pregnancy. Clinical trial findings supported the FDA’s approval of Levemir® for a pregnancy Category B classification in 2012. I cannot stress enough how rare this categorization is for drugs used in pregnancy and the level of reassurance it provides for patients and providers.
Statement #12
The decision to stop producing insulin Levemir® will have a dire impact on the therapeutic landscape of diabetes in pregnancy. Non-insulin alternatives are standard outside of pregnancy. However, findings of transplacental transfer of glyburide and metformin as well as embryotoxic effects in animal models on newer agents have limited the use of non-insulin drugs in pregnancy. Pregnant individuals with diabetes are faced with significant potential maternal and risks as well as limited treatment options because of concerns for safety. Further limits on their treatment options because of global manufacturing issues and decreasing patient coverage will leave patients with fewer treatment options and no equivalent treatment options during pregnancy.
Statement #13
For individuals with variable insulin requirements, Levemir provides flexible dosing options that enhance glycemic control and safety. Unlike longer-acting insulins such as Degludec and Glargine, Levemir’s shorter duration minimizes the danger of nocturnal hypoglycemia (low blood sugar) in these populations, ensuring their safety. Additionally, Levemir has shown lower within-person variability in glucose absorption compared to other insulins, leading to more consistent blood glucose levels and further reducing the risk of hypoglycemia. Given the significant variability in basal insulin needs among individuals, it is crucial for Levemir to remain available in the physician's formulary to prevent both hypo- and hyperglycemia effectively. The ability to titrate insulin accurately to achieve normoglycemia is vital for the health and safety of every diabetic patient, and Levemir's action profile supports this objective for many diabetic individuals. Discontinuing Levemir would reduce the diversity of insulin options, potentially compromising optimal diabetes care.
