Types of Insulin

There are more than 20 types of insulin products available in four basic forms, each with a different time of onset and duration of action. The decision as to which insulin to choose is based on an individual's lifestyle, a physician's preference and experience, and the person's blood sugar levels. Among the criteria considered in choosing insulin are:

What is diabetes?

Diabetes mellitus is a chronic disease in which blood glucose (sugar) levels are too high. Cells in the body break down glucose in order to provide energy for movement, growth, and repair. The hormone insulin is responsible for regulating glucose levels in the blood. Abnormally high levels of glucose can damage the small and large blood vessels, leading to diabetic blindness, kidney disease, amputations of limbs, stroke, and heart disease.

There are three common types of diabetes. Type 1 diabetes is usually (but not always) diagnosed in children and young adults. Persons with type 1 diabetes make no insulin and must take insulin every day. Type 2 diabetes is usually (but not always) diagnosed in adults over the age of 45. In type 2 diabetes, either the person is not making enough insulin, or the body is resistant to insulin and cannot use it properly. Gestational diabetes occurs during pregnancy: 2-4 percent of all pregnant women have gestational diabetes. If a woman has gestational diabetes, she has about a 40 percent chance of having type 2 diabetes later in her life.

About 17 million persons in America have Diabetes mellitus, but five million of them don't even know it. Nearly 1 million new cases are diagnosed each year. The disease affects men and women of all ages and ethnic groups. African Americans, Latinos, American Indians, Alaskan Natives, Asian Americans, and Pacific Islanders are more greatly affected than other groups.

For more information about diabetes, use the following links:

How do I know if I have diabetes?

As many as 50 percent (one-half) of persons with type 2 diabetes are unaware that they have the disease. For this reason, it is particularly important to pay attention to the signs and symptoms of diabetes and its risk factors.

Some of the signs of either type 1 or type 2 diabetes are:

• being very thirsty
• urinating often
• feeling very hungry or tired
• losing or gaining weight without trying
• having sores that heal slowly
• having dry, itchy skin
• losing the feeling in your feet or having tingling in your feet
• having blurry eyesight

Symptoms of type 1 diabetes often develop over a short period of time. In type 2 diabetes, symptoms develop more slowly, and some persons never have any symptoms of the disease. If you are regularly having any of these signs and symptoms, you should tell your doctor.

What factors increase my risk of getting diabetes?

Although researchers don't fully understand why some persons get diabetes and others don't, it is clear that certain factors increase your risk. You are at risk for having diabetes if:

• Your mother, father, sister, or brother has diabetes;
• You are African American, Hispanic American/Latino, American Indian, Native Alaskan, Asian American, or Pacific Islander;
• You have high blood pressure (at or above 130/80);
• You have a history of diabetes during pregnancy (gestational diabetes) or gave birth to a baby weighing more than nine pounds at birth;
• You are overweight or obese;
• You are inactive or have a sedentary lifestyle; or
• You are older than 45 years of age.

If you have one or more of these risk factors, even if you are experiencing no symptoms, your doctor may want to test you for diabetes.

How can I reduce my chance of getting diabetes?

A recent study funded by the Federal government of 3,234 persons at high risk for diabetes showed that diet and exercise can sharply lower the risk of getting type 2 diabetes.

The Diabetes Prevention Program (DPP) was a major clinical study of ways to prevent or delay diabetes in persons at high risk for type 2 diabetes. Patients were overweight and had higher than normal levels of blood glucose, called impaired glucose tolerance. Both conditions are strong risk factors for type 2 diabetes. Because of the high risk among some minority groups, about half of the DPP participants were African American, American Indian, Asian American, Pacific Islander, or Hispanic. The DPP compared two methods for preventing diabetes: (1) an intensive program of healthy eating and exercise and (2) the use of metformin, a diabetes drug. Persons who engaged in moderate physical activity for about 30 minutes a day, followed a low-fat and low-calorie diet, and lost 5 to 7 percent of their body weight (or about 12 pounds for someone who weighs 200 pounds) cut their risk of getting type 2 diabetes by about one half (58%). Those persons receiving metformin reduced their risk by one third (31%).

For more information about reducing your risk of getting type 2 diabetes, use the following link: NIDDK Diabetes Prevention Program

Does FDA develop or test new medicines or other treatments for diabetes?

FDA does not develop or test new medicines or other treatments. Instead, FDA evaluates the information from manufacturers who have tested their medicines. FDA does give substantial advice to the companies who are developing the drugs or other products.

How are new drugs approved by FDA?

Since 1938, every new drug has been the subject of an approved New Drug Approval (NDA) application before it is sold in the U.S. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.

The goals of the NDA are to provide enough information to permit FDA reviewers to reach the following key decisions:

• whether the drug is safe and effective in its proposed use or uses.
•  whether the benefits of the drug outweigh the risks.
• whether the drug's proposed labeling (package insert) is appropriate and what it should contain.
• whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's indentity, strength, quality, and purity.

Phases of Clinical Trials

After a drug is shown to have promise in terms of effectiveness and an adequate measure of safety for humans during animal studies, it moves into clinical trials to test for effects in humans. Clinical trials are categorized into the following phases:

Phase I - Small studies, usually involving 20 to 80 patients, for the purpose of determining safety.

Phase II - Larger studies, involving up to several hundred subjects, to further explore safety and to determine effective dosage for a specific indication.

Phase III - Still larger studies, involving up to several thousand subjects, for the purpose of gathering additional information about safety, efficacy, and dosage that is needed to determine the overall benefit-risk relationship of the drug and to characterize the drug for its intended use. 

How do I know if my diabetes medicines are working?

Monitor your blood sugar daily to see if your diabetes medicines are working properly. Consult your doctor if you think your medicines are not working correctly. For best results, oral medications must be taken regularly every day, not irregularly or started and stopped according to blood sugar. Since many dosages are available, a physician can change the dosage if blood sugars are running too high or too low. Some of these drugs can be used in combination with one another. You should change your diabetes medicines only when your doctor advises you to.

How can I get more information about medical devices?

There are many sources of information about medical devices and procedures including information on the internet from health care organizations, medical centers, and consumer organizations. One accurate source of information about the risks and benefits of the product is the patient labeling prepared by the manufacturer and reviewed by FDA. Patient labeling is available for many of the devices listed in the premarket approval database.