The FDA reclassified insulin detemir (Levemir) into pregnancy category B, indicating that the product may be used by pregnant women without risk of fetal injury, its manufacturer said.
Novo Nordisk said insulin detemir is the first basal insulin analog to receive this classification.
The company had sponsored a randomized 310-patient trial involving pregnant women with type 1 diabetes to establish insulin detemir’s safety in this population.
No unusual safety signals were seen either in mothers or in their offspring, Novo Nordisk said. The company noted that more than 1.8 million women of childbearing age in the U.S. have diabetes.
Levemir® (insulin detemir [rDNA origin] injection) is an insulin therapy that is safe and effective for some patients with diabetes. It is proven to help you get to your blood sugar goal. Using the Levemir® FlexPen® helps control blood sugar levels - all day and night for up to 24 hours.
You may have recently been prescribed Levemir® to help control your diabetes, or you may be considering Levemir® for the first time. Whether you’re new to insulin therapy or have previously used another insulin, the important thing is finding and sticking to a treatment strategy that is right for you. With 24-hour coverage, a low rate of low blood sugar, and proven weight benefits, Levemir® FlexPen® can help you get to goal. Talk to your doctor to see if Levemir® may be right for you.
Levemir® is a long-acting insulin
Levemir® is used to treat both type 1 and type 2 diabetes. As an insulin therapy that helps control blood sugar levels between meals and while you sleep, Levemir® is a long-acting insulin.
In people without diabetes, long-acting insulin, or basal insulin is produced by the pancreas in a steady amount, day and night. This keeps blood sugar within a normal range overnight and between meals. With diabetes, your pancreas does not make enough insulin to control your blood sugar. As a long-acting insulin, Levemir® helps control your blood sugar for up to 24 hours.
Some people may take Levemir® by itself, while others may take Levemir® along with diabetes pills or with a fast-acting, or bolus insulin.
Levemir® in combination with diabetes pills
When you are first diagnosed with diabetes, your doctor may prescribe meal planning, exercise, and diabetes pills to help control your blood sugar levels. However, diabetes pills sometimes stop working after a few months or years. This may be due to the way diabetes pills work, or to your diabetes changing over time. When you need more control over your blood sugar levels, your doctor may recommend combination therapy with diabetes pills and Levemir®.
Levemir® in combination with a fast-acting insulin
People who take Levemir® may also take a fast- or rapid-acting insulin. In people without diabetes, fast-acting insulin is released in quick bursts after a meal to cover the blood sugar that is produced when food is digested. Fast-acting and long-lasting insulins work together to control blood sugar.
Taking a long-acting insulin such as Levemir® and a fast-acting insulin is called “basal-bolus therapy.” Basal-bolus therapy is useful for people with diabetes who need more control over their blood sugar levels.