Diabetes and Lipid Clinic of Alaska

 

 


Byetta

In 1902, Researchers first hypothesized that the gut might directly signal the pancreas. The term incretin was first used in 1930 to describe the enhanced glucose lowering effect that was seen when a gut extract was fed to dogs. In the 1960s, researchers discovered that almost twice as much insulin was released when they infused glucose directly into the gut rather than into the blood as an IV solution, renewing interest in a search for compounds produced by the gut that could lower blood glucose levels.

The first incretin released by the FDA was Byetta which was approved in May of 2005. It is available by prescription for people with Type 2 diabetes who are not on insulin. Byetta is a GLP-1 agonist or drug that works like GLP-1. It is rather unusual in that it is derived from a compound found in the saliva of the Gila monster, a large lizard native to the southwestern US.

When food is eaten, GLP-1 (glucagon-like peptide 1) is one of several incretin compounds that have biologic activity. Following its release into the blood by the intestine in response to food intake, GLP-1 impacts several organs including the intestines where it slows food absorption. This delay in absorption allows the slow insulin response found in Type 2 diabetes to catch up. Improved insulin production by the pancreas is also seen.

An increase in insulin release toward normal has been seen in Type 2 diabetes who take Byetta. Rather than being glucagon-like and raising glucose levels, GLP-agonists lessen the excessive release of glucagon seen in Type 2 diabetes. Researchers hope this might delay progression of Type 2 diabetes.

So far, Byetta's impact on lowering glucose levels, blood pressure and reductions in weight, plus an increase in a sense of well being have largely been positive.

Side effects like nausea that does not go away on minimal doses may require that the medication be stopped or that smaller starting doses be given with a syringe rather than using the standard starting dose of 5 mg that is provided in the Byetta pen.

On a more serious side, "rare" case reports of pancreatitis and "very rare" case reports of pancreatitis with complications or fatalities have been reported in Byetta users, and the FDA has requested a stronger warning label.

In addition to the delay in food absorption, GLP-1 agonist also stimulate insulin production and restore first phase insulin secretion. The overall effect is to decrease the postmeal blood sugars and improve control without the risk of hypoglycemia. Research has shown that people on Byetta eat about 20%less and often lose weight.
Giving natural GLP-1 was found to have little benefit because it is broken down by an enzyme called DPP-4 (dipeptidyl peptidase IV) within about 5 minutes. This lead to a search for modified GLP-1 molecules like Byetta, produced by Amylin and Lilly, that are not broken down as quickly. Other new GLP-1 derivatives are currently in clinical trials. These include liraglutide by Novo-Nordisk which will probably reach the market by 2010.

BYETTA works with pills like Glucophage® (metformin) and/or sulfonylureas like Amaryl® (glimepiride), Glucotrol® (glipizide), Micronase® (glyburide), and others to help with blood sugar problems in several ways:

  • Insulin production: BYETTA signals your pancreas to make the right amount of insulin after meals to help lower blood sugar closer to normal levels —then stops causing the pancreas to produce more insulin after blood sugar levels get closer to normal
  • Sugar production: BYETTA helps stop your liver from producing too much sugar when you don't need it—helping you avoid high blood sugar levels
  • Sugar digestion: BYETTA helps slow down the rate at which sugar enters your bloodstream—also helping you avoid high blood sugar spikes

BYETTA may give you better control of your blood sugar by helping your body manage its own blood sugar levels. BYETTA works when you need it—not when you don't.

For many people, trying to maintain the right blood sugar levels day after day can be frustrating. BYETTA may help you get improved control of your type 2 diabetes by helping your body produce the right amount of insulin at the right time.

In clinical trials, improvements in blood sugar levels were seen as soon as the first day in patients taking BYETTA. This led to improvements in A1C (a 3-month average of your blood sugar levels). If you check your blood sugar at home, you should see your levels get better, especially after you eat.

You do not need to do extra blood sugar monitoring while on BYETTA. However, since BYETTA is taken before a meal, checking your blood sugar levels 2 hours after you eat will let you know how your BYETTA is working. Following your healthcare professional's recommendations for lab tests and home blood sugar monitoring is important to seeing how well your diabetes is controlled.

BYETTA improves blood sugar control in adults with type 2 diabetes. It is used with metformin, a sulfonylurea, or both.

BYETTA is not a substitute for insulin in patients whose diabetes requires insulin treatment. BYETTA has not been studied in children.

Before using BYETTA, tell your healthcare provider about all of your medical conditions, including if you have severe problems with either your stomach or food digestion; if you have severe kidney disease; or if you are pregnant, plan to become pregnant, or are breastfeeding.

When BYETTA is used with a medicine that contains a sulfonylurea, low blood sugar (hypoglycemia) is a possible side effect. The dose of your sulfonylurea medicine may need to be reduced while you use BYETTA.

Other common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea is most common when first starting BYETTA, but decreases over time in most patients.

BYETTA may reduce your appetite, the amount of food you eat, and your weight. No changes in your BYETTA dose are needed for these side effects.

These are not all the possible side effects from the use of BYETTA. Talk to your healthcare provider about any side effect that bothers you or that does not go away If your current oral diabetes medicines are no longer able to give you enough control of your blood sugar, your healthcare professional may prescribe BYETTA for you. BYETTA is an injectable medicine that comes in a prefilled pen. Even though it is an injection, BYETTA is not insulin and is not a substitute for insulin. BYETTA actually helps your body make more of its own insulin.

Since BYETTA comes in a prefilled pen with simple, fixed dosing for all patients, you don't have to guess what dose you need based on the size of your meal or how much you exercise. Your healthcare professional will start you off with a dose of 5 micrograms (mcg) twice a day for at least 30 days, but may decide to increase your dose to 10 mcg in the future.

You should take BYETTA twice daily—once before your morning and evening meals. After each injection, you should eat your meal anytime during the following 60 minutes. Your healthcare professional will give you instructions on the proper use and storage of the BYETTA Pen when you get your first prescription.

BYETTA comes in a pre filled pen with simple, fixed dosing for all patients. With BYETTA, you don't have to do additional blood sugar monitoring or guess what dose you need based on the size of your meal or how much you exercise.

Because BYETTA is a protein it must be taken by injection. If it were taken in pill form, your stomach would break it down just like the protein in the foods you eat, and it wouldn't work.

BYETTA is taken as an injection, twice a day, at any time within the 60 minutes before your morning and evening meals. BYETTA should not be taken after a meal.

  • BYETTA comes in a prefilled injection pen which uses a very small needle
  • The BYETTA Pen is suitable for use with a variety of pen needles
  • Pen needles must be purchased separately and may require a prescription
  • Since the pen device contains pre-measured doses, you will never have to adjust the dose in that pen
  • BYETTA should be taken twice daily—once before your morning and evening meals
  • After each injection, you should eat your meal anytime during the following 60 minutes
  • BYETTA should be injected into your abdomen, thigh, or upper arm. Click on the button to the right to view the injection areas
  • When the pen is not in use, it should be stored in the refrigerator to make sure it stays at 36°F to 46°F. BYETTA should never be frozen. If that happens, it must be thrown away
  • You should also avoid leaving the pen in direct sunlight. When you need to take your BYETTA Pen with you, it must be kept cool as well
  • Your healthcare professional should start you off with a dose of 5 micrograms (mcg) twice a day for at least 30 days, but may decide to increase your dose to 10 mcg in the future

In clinical trials, improvements in blood sugar levels were seen as soon as the first day in patients taking BYETTA. This led to improvements in A1C (a 3-month average of your blood sugar levels). If you check your blood sugar at home, you should see your levels get better, especially after you eat.

You do not need to do extra blood sugar monitoring while on BYETTA. However, since BYETTA is taken before a meal, checking your blood sugar levels 2 hours after you eat will let you know how your BYETTA is working. Following your healthcare professional's recommendations for lab tests and home blood sugar monitoring is important to seeing how well your diabetes is controlled.

Will BYETTA affect my weight?

Patients taking BYETTA may feel less hungry and eat less—in clinical trials, most people lost weight.

If you're trying to lose weight, a combination of physical activity and wise food choices can help you reach your target weight and maintain it. Physical activity is especially good for people with diabetes because it can lower your blood sugar, blood pressure, and cholesterol. In addition, regular activity helps insulin work better, improves your blood circulation, and keeps your joints flexible. Before starting any exercise program, you should check with your healthcare professional.

What are the possible side effects?

The most common side effect with BYETTA is mild-to-moderate nausea, which goes away with time in most people. If you experience nausea, your healthcare professional can give you tips on how to manage it. Other side effects with BYETTA include hypoglycemia, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. These are not all the side effects with BYETTA. Ask your healthcare professional or pharmacist for more information.

Will I have to worry about low blood sugar (hypoglycemia)?

If you use BYETTA when you are taking a medicine that contains a sulfonylurea—such as Amaryl® (glimepiride), Glucotrol® (glipizide), Micronase® (glyburide), and others—low blood sugar may occur. Your doctor may need to reduce the dose of your sulfonylurea medicine. Ask your healthcare professional or pharmacist if you are not sure if your antidiabetic medicine contains a sulfonylurea. Do not take BYETTA if your blood sugar is too low, particularly if you are taking a sulfonylurea medicine. Let your healthcare professional know if you think your blood sugar levels are too low. If you are unsure, ask your healthcare professional about what blood sugar levels are right for you.

Will BYETTA affect the other medicines I take?


BYETTA is approved for use with metformin and/or a sulfonylurea. BYETTA may slow the way some other oral medicines are absorbed, especially if you take those medicines with a meal. In clinical studies, BYETTA did not interfere with commonly prescribed medicines. Make sure your healthcare professional knows about any medicines you may be taking, including prescription and non-prescription medicines, vitamins, and herbal supplements

The information on this Web page is provided for educational purposes. You understand and agree that this information is not intended to be, and should not be used as, a substitute for medical treatment by a health care professional. You agree that Diabetes and Lipid Clinic of Alaska is not making a diagnosis of your condition or a recommendation about the course of treatment for your particular circumstances through the use of this Web page. You agree to be solely responsible for your use of information contained on this Web page

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