What is Tresiba?
Diabetes is a lifelong disease that has no cure. It is characterized by high blood glucose levels due to the body’s inability to process blood sugar. The hormone, insulin, is normally responsible for processing blood sugar. In diabetes, the body cannot make insulin or it does not make enough insulin that is able to transport glucose out of the blood. Almost a hundred years ago, diabetes was a fatal disease due to lack of treatment methods. Today, diabetes is a largely manageable condition that lets patients live a relatively normal and healthy life as long as they follow a treatment regimen that involves a combination of dietary changes, exercise and prescription drugs.
There are two main types of diabetes. Type 1 diabetes is an autoimmune condition in which the pancreas that normally produces insulin cannot make it at all. This type of diabetes is most often diagnosed in childhood. In type 2 diabetes, the pancreas can make some amount of insulin, but it is either not enough to process blood sugar, or it cannot function properly to move glucose out of the blood. Gestational diabetes can also occur during pregnancy when blood sugar levels are above normal but below diabetic levels. Gestational diabetes must be treated to avoid serious health risks to the pregnant mother and child.
If left untreated, diabetes can cause serious health risks that include blindness, kidney damage, heart attack, stroke, lower limb amputations and impaired wound healing. It is important to know whether you are at risk of developing diabetes through regular blood tests. Pre-diabetes, a condition that predisposes an individual to the development of diabetes, affects almost one-third of all adults in the United States. By implementing lifestyle changes, pre-diabetes will not necessarily become diabetes.
History of Insulin Analogs
The major medical landmark that changed diabetes from a fatal condition into a treatable one was the discovery of artificial insulin that could be injected into a patient. In the early 1920’s, a physician named Frederick Banting and his assistant, Charles Best, made this discovery. The first versions of insulin that were used to treat diabetic patients came from animal sources. But this approach was problematic as it sometimes elicited an allergic response in patients. In 1978, a biosynthetic version of human insulin was created by Eli Lilly and Company by introducing the human insulin gene into the bacteria, E. coli. This breakthrough discovery led to successful long-term treatment of diabetes since biosynthetic insulin was exactly like natural human insulin.
Today, synthetic insulin has been further modified to develop different types of insulin that can be used to help the body process sugar at specific times of the day. ‘Basal’ insulin works throughout the day and ‘bolus’ insulin can process quick rises in blood sugar. For example, when you eat a meal or snack, the carbohydrates present in the food will be converted into glucose that causes a sudden rise in blood glucose levels. At this time, more insulin is needed quickly. At other times, such as during nighttime when the patient is sleeping, there is less demand for large amounts of insulin in the body to process a sudden rise in blood sugar. To address the need for varying levels of insulin throughout the day, different types of insulin analogs have been created that are FDA-approved. Rapid-acting insulin is used for sudden increases in blood sugar such as after snacks or meals, and long-acting insulin is used when a steady amount of stable insulin is needed over a long period of time such as at bedtime.
Tresiba, also known as ‘insulin degludec’ is a type of long-acting insulin that is used as a basal insulin. Tresiba is used to treat type 1 and type 2 diabetes. Other well-known long-acting synthetic insulin formulations are insulin glargine, also known as the brand name Lantus, and insulin detemir, also known as the brand name Levemir.
How was Tresiba discovered?
The first long-acting insulin to hit the market was insulin glargine in 2000. Before this, the longest acting insulin (NPH insulin), which is now considered to be intermediate-acting, peaked in action at around 6 hours after being administered by the patient and would often result in hypoglycemia or low blood sugar. Insulin glargine was created by structural modification of human insulin to last for 24 hours in the body. Tresiba (insulin degludec) is also an ultra-long acting insulin analog that can last for more than 24 hours in the body once it is administered. The effects of Tresiba can last even longer than insulin glargine and reportedly last for up to 42 hours. This ensures that it has to be taken only once daily, unlike other long-acting insulin formulations that display variability in their duration of action in some patients.
Tresiba flextouch was developed by Novo Nordisk by addition of hexadecanedioic acid to the amino acid lysine that is normally present at the 29th position in the B-chain of natural human insulin.
The efficacy and safety of Tresiba was studied in a rigorous clinical trial, named the BEGIN-Basal-Bolus Type 2 trial. This trial studied how Tresiba performed as a basal insulin compared to insulin glargine when taken along with mealtime diabetes medications such as insulin aspart or metformin. Results of the trial showed that Tresiba was able to lower blood sugar levels as well as insulin glargine, but it also had the added benefit of significantly lowering hypoglycemia, which is a side effect of insulin glargine. Tresiba was further studied in the clinical trials for its performance in treating type 1 diabetes. The medication was found to be safe and as effective in reducing blood sugar levels as insulin glargine. It also significantly reduced hypoglycemia that occurs at night by up to 27 percent.
Tresiba was FDA-approved for treating type 2 diabetes in 2015, and it was approved for the treatment of type 1 diabetes in 2016. The reduced hypoglycemia caused by Tresiba compared to other insulins is largely what makes it stand out from pre-existing long-acting insulin formulations. Some patients on insulin glargine have reported experiencing peaks of action long before 24 hours post-injection, which ultimately leads to hypoglycemia. This is a dangerous side effect of insulin therapy and the ability of Tresiba to significantly counter this effect was considered to be advantageous.
How does Tresiba work?
Insulin becomes active in the body when it is in a monomer form. The rapid acting insulins are released as monomers so they start acting immediately. The chemical modification in Tresiba assembles insulin into a form of multihexamers. When this is injected into the body, the hexamers are released slowly over time into active monomers. This ensures that Tresiba is ultra-long acting and will not peak in concentration shortly after being administered. It usually takes a few hours to start working after injection and continues to work at an even pace for 24 hours after that. Unlike insulin glargine that has an acidic pH formulation, which can cause the area of injection to sting in some patients, Tresiba is active at the normal physiological pH of the body.
How to use Tresiba
Tresiba is available as a single patient use FlexTouch pen at two different strengths (100 units/mL or 200 units/mL) and as multiple dose vials. Tresiba is injected under the skin and should be used only once a day at any time of the day. Your health provider will provide specific instructions on how to safely make the injection and any other details you need to know about how to take Tresiba with other medications you are taking for diabetes. The usual initial adult dose for type 2 diabetes is 10 subcutaneous units a day. This may be adjusted as the treatment continues. For type 1 diabetes, Tresiba should be used in a regimen that also contains short or rapid-acting insulin. The usual initial dose for type 1 diabetes is half or one-third of the total daily insulin requirement per day. The injection pen used for Tresiba should never be shared with anyone else and Tresiba should not be used in an insulin pump. Pay attention to any symptoms of hypoglycemia that might occur while you are using Tresiba.
Cost of Tresiba and how to save
Since Tresiba is only available as a brand-name drug and there are no generics available for it, it is quite expensive compared to other types of insulin that are on the market. The cash price of Tresiba is currently between $360-$390 for 100mL, or about $36 for a unit. Even with health insurance, the price you pay out-of-pocket can be on the steep end, as it will depend on insurance co-pay policies.
You can find ways to save on the price of Tresiba through a few different sources. Novo Nordisk, manufacturer of Tresiba, offers patient assistance programs to eligible individuals without health insurance. Another great option is by using a drug coupon. One such coupon for Tresiba is available from USA Rx. If you have diabetes, you are likely taking more than one prescription drug as a part of your treatment plan. If this applies to you, then signing up for a prescription drug discount card can help you save on the cost of all medications that you purchase. Signing up for the discount card from USA Rx is free and has no eligibility requirements. You can simply take the card in with you when getting your prescription filled to start saving.