Synthetic amylin is a manufactured form of amylin, a hormone that increases release of insulin in the body. The U.S. Food and Drug Administration (FDA) approved this injected medication in 2005 for treating adults whose type 1 diabetes or type 2 diabetes cannot be controlled by insulin alone.

Discovered in the 1987, amylin is released from the beta cells of the pancreas. These are the same cells that secrete insulin. As with insulin, amylin is absent in people with type 1 diabetes and does not work effectively in patients with type 2 diabetes.

Synthetic amylin functions by slowing the movement of food from the stomach to the small intestine. It helps to keep glucose levels from becoming too high immediately after meals and falling too low several hours after eating.

Side effects are usually mild to moderate and include nausea, vomiting, abdominal pain, headache, fatigue and dizziness. The severity of side effects tends to lessen over time and may stop within four weeks of beginning treatment.

Synthetic amylin is the only medication approved for treating type 1 diabetes since insulin was introduced more than 80 years ago. It is sold under the brand name Symlin (pramlintide acetate).

Synthetic amylin must be taken carefully under a physician’s supervision to avoid the potential for developing severe hypoglycemia. It is not recommended for certain patients, such as those with gastroparesis or hypoglycemia unawareness.

Synthetic amylin is the only drug other than insulin approved for treating type 1 diabetes. It can also be prescribed to patients with type 2 diabetes who have unstable diabetes despite use of insulin.

Sold under the brand name Symlin and also known as pramlintide acetate, it is a synthetic version of the natural hormone amylin. It is intended for use by patients who find that insulin therapy alone is insufficient in keeping glucose (blood sugar) levels in a physician-approved target range.

Synthetic amylin is the first member of a new class of drugs known as amylinomimetic agents, also known as amylin receptor agonists. This class of drugs mimics the effect of the amylin. When people without diabetes eat, the beta cells of the pancreas release insulin and amylin to help keep glucose levels from rising too high in the bloodstream. Meanwhile, levels of the hormone glucagon – which triggers the liver to release stored glucose reserves – fall after a meal.

However, patients with type 1 diabetes do not produce insulin or amylin to keep glucose levels in check. Patients with type 2 diabetes have cells that are resistant to these hormones or lack adequate amounts of them. In addition, patients with diabetes tend to see glucagon levels rise after eating a meal, and thus triggering a surge in glucose levels.

Many patients with type 1 diabetes find insulin therapy sufficient to keep their glucose levels in check, and most people with type 2 diabetes who cannot control their disease with exercise and diet find oral antidiabetic agents and/or insulin adequate. However, other patients struggle with glucose control despite insulin therapy.

For these patients, synthetic amylin may provide additional help. This medication functions in the following ways:

• Controls delivery of nutrients to the stomach. Synthetic amylin delays gastric emptying of food into the small intestine, thereby preventing postprandial (after-meal) hyperglycemia. In addition, synthetic amylin facilitates the storage of glucose in the liver as glycogen, which can be released when glucose levels in the blood begin to fall. This helps prevent hypoglycemia.
  
  
• Suppresses the brain’s appetite center. Research has shown that amylin causes the central nervous system to signal satiety (feeling of fullness) to the body. This may help to promote weight loss and helps keep glucose levels lower. Some patients using medications to control glucose gain weight because the body uses or stores the glucose that previously was eliminated during urination.
  
  
• Suppresses secretion of postprandial glucagon. Glucagon is a hormone that acts contrary to insulin and helps release glucose stored in the liver.
  
  
• Improve levels of hemoglobin A1C (HbA1C). HbA1C levels detected in a glycohemoglobin test provide an estimate of  long-term control of glucose. Synthetic amylin helps to improve HbA1C levels and therefore glycemic control.

The Food and Drug Administration (FDA) in 2005 approved synthetic amylin for use by adults whose type 1 or type 2 diabetes cannot be controlled by insulin therapy alone. The new medication has not yet been tested in patients with diabetes under the age of 18.

Synthetic amylin is administered by injection, usually in the abdomen or thighs. To prevent hypoglycemia, the medication is given before meals containing a minimum of 250 calories or 30 grams of carbohydrates. Synthetic amylin and insulin should not be mixed together, and should be injected in different syringes at sites at least two inches (5 centimeters) apart because of reactions that occur between the two hormones.

Synthetic amylin (Symlin, pramlintide acetate) should be taken only under a physician’s supervision to avoid the potential for severe hypoglycemia. This risk is greatest in patients with type 1 diabetes or gastroparesis, a form of autonomic neuropathy that results in delayed stomach emptying, and symptoms such as nausea, vomiting and abdominal distension.

The U.S. Food and Drug Administration (FDA) advises the following patients to refrain from using synthetic amylin:

• People who cannot tell when their glucose (blood sugar) levels are low (hypoglycemic unawareness)
  
  
• People with gastroparesis
  
  
• People with allergies to any of the following chemicals that may be used in pharmaceuticals:
  
  
• Metacresol (a preservative)
  
  
• D-mannitol (a sweetener and laxative)
  
  
• Acetic acid (an industrial chemical and a compound in vinegar)
  
  
• Sodium acetate (a food preservative)

Side effects associated with synthetic amylin use are generally mild to moderate and may include:

• Nausea
  
  
• Vomiting
  
  
• Abdominal pain
  
  
• Headache
  
  
• Fatigue
  
  
• Dizziness

Patients may experience hypoglycemia, especially those with type 1 diabetes, according to the U.S. Food and Drug Administration.

The physician may prescribe synthetic amylin in gradually increasing doses. This helps the body adjust and lessens the occurrence of side effects. The side effects also typically pass within four weeks of beginning treatment.

Research indicates that side effects are likely to be more severe in patients with type 1 diabetes than those with type 2 diabetes.

Patients using synthetic amylin (Symlin, pramlintide acetate) should consult their physicians before using alcohol, taking any additional prescriptions, over-the-counter medications, nutritional or herbal supplements. Anticholinergic medications (used to treat conditions including colds, stomach cramps, Parkinson’s disease, urinary incontinence and lung disease) delay stomach emptying, and the use of these medications along with synthetic amylin should be discussed in advance with a physician.

Physicians are likely to change the patient’s dosage of insulin when synthetic amylin is first administered. Future doses of insulin and synthetic amylin will be adjusted to help the patients achieve optimal control of glucose (blood sugar). Synthetic amylin and insulin are not mixed in the same syringe because insulin will reduce the effectiveness of synthetic amylin. The two hormonal medications are injected at different sites on the body a minimum of 2 inches (5 centimeters) apart to avoid mixing.

Synthetic amylin slows the movement of food from the stomach and may delay the absorption of oral medications. It is recommended that medications that must be rapidly absorbed be taken either one hour before or two hours after the injection of synthetic amylin.

The Food and Drug Administration (FDA) states that synthetic amylin (Symlin, pramlintide acetate) should be used only by patients who:

• Use insulin as prescribed by a physician but require better glucose (blood sugar) control
  
  
• Are willing to precisely follow their physician’s instructions
  
  
• Agree to perform glucose monitoring before and after every meal and at bedtime
  
  
• Understand how to adjust doses of synthetic amylin and insulin when necessary

Patients unwilling to follow these requirements face the potential complication of severe hypoglycemia (insulin shock) and other adverse health effects.

Patients who fail to administer a dose should take their usual dosage at the next meal, according to the FDA.

A physician-prescribed sick-day plan can help patients deal with medications and other issues when experiencing an illness.

The effects of synthetic amylin on pregnant or breastfeeding patients have not been studied. Research with animals found that very heavy doses may cause birth defects and other health problems. This medication should be used during pregnancy or breastfeeding only if the physician determines that the potential benefits outweigh the potential risks, according to the U.S. Food and Drug Administration (FDA).

Preparing questions in advance can help patients have more meaningful discussions with their physicians regarding their conditions. Patients may wish to ask their doctor the following questions about synthetic amylin:

1. Will synthetic amylin help me better control my glucose?
   
   
2. When and how should I take this drug?
   
   
3. What happens if I miss a dose?
   
   
4. What if I miss a meal?
   
   
5. What if I take too much medication?
   
   
6. How do I store the medication?
   
   
7. Will my insurance company cover it?
   
   
8. What are the side effects I need to report to you?
   
   
9. Are there ways to lessen the side effects?
   
   
10. What do I do if a family member takes my medication?
    
    
11. What do I do if my synthetic amylin and insulin get mixed?