The IAA One Minute Blog

A biological therapy that delays the onset of type 1 diabetes received approval from the U.S. Food and Drug Administration (FDA).

Preventing Type 1

The biological therapy called Teplizumab (Tzield) is the first therapy approved for the prevention of type 1 diabetes.

The FDA said the approval was based on a phase 2 clinical trial of 76 participants who were randomly assigned to receive the drug or a placebo once daily intravenously for 14 days. People in the trial had an early form of type 1 diabetes in which blood sugar levels are abnormal, but symptoms have not yet developed. In clinical trials, the treatment delayed progression to full blown diabetes by a little over two years. But the benefits have lasted much longer in some of the study participants.

The trial found that the median time to diagnosis for people who received Tzield was about four years, compared to two years in the placebo group.

The therapy is thought to work by turning down the body’s misdirected attack on its own insulin-producing cells. The idea is that protecting these cells buys people more time before they become dependent on insulin to manage their condition.

The drug is approved for use in people eight and older who are in stage 2 of their type 1 diabetes. In that stage, doctors can measure antibodies that attack insulin-producing beta cells in the person’s blood, and they have abnormal blood sugar levels, but their body can still make insulin.

The treatment comes in a single 14-day course of infusions that each last 30 to 60 minutes.

Symptoms of Type 1 Diabetes

In people with type 1 diabetes, the body doesn’t make insulin, a hormone that tells cells to use sugar from the bloodstream to make energy. Without insulin, too much sugar can stay in the blood, which can lead to health problems.

Symptoms can appear suddenly and may include:

• Bed wetting in children who have never wet the bed during the night
• Feeling irritable or having other mood changes
• Feeling more thirsty than usual
• Feeling tired and weak
• Feeling very hungry
• Frequent urination
• Having blurry vision
• Losing weight without trying

As of 2019, about 1.9 million people have type 1 diabetes in the United States, according to the American Diabetes Association, including 244,000 children and adolescents.  

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