Experimental Treatment Could Slow Down Type 1 Diabetes In High-Risk Individuals

Experimental Treatment Could Slow Down Type 1 Diabetes In High-Risk Individuals

Experimental Treatment Could Slow Down Type 1 Diabetes In High-Risk Individuals

The applicants were randomly allocated to the treatment group that received a 14 days course of teplizumab that received a placebo.

By comparison, among the 32 people who received a placebo, 23, or 72%, developed diabetes, with half the patients developing it within 24.4 months. Those given the drug developed the autoimmune disease in an average of 48 months. The drug is being developed by Provention Bio Inc. and is not yet approved by the FDA.

Still, "keeping kids off insulin as long as possible is really exciting", Dunne said.

A delay in diagnosis also means two fewer years with the disease. That might translate into fewer complications later in life, according to the JDRF.

The study was conducted by the Type 1 Diabetes TrialNet, an worldwide collaboration aimed at discovering ways to delay or prevent type 1 diabetes (T1D), and evaluated Provention's PRV-031 (teplizumab) for the prevention or delay of clinical T1D in relatives of type 1 diabetics at high-risk of developing the disease. Insulin is a hormone that helps usher the sugar from foods into the body's cells to be used as fuel.

These people must replace that lost insulin through daily injections or an insulin pump.

Karen Addington, UK Chief Executive of type 1 diabetes research charity JDRF, said: "Type 1 diabetes can be tough". Teplizumab targets the T cells to reduce the flattening of beta cells. "We've had trials that have been going on for a couple of decades, but they have not been able to prevent diabetes", declared Kevan Herold, a professor of immunology and endocrinology at Yale University and the lead author of the study. Most were under 18 years old. Also, the volunteers all had tests showing diabetes-related autoantibodies that attack the pancreas, plus unhealthy blood sugar levels. The others were given a placebo by IV.

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Russell says people who are in stage 2, (antibodies plus impaired glucose tolerance) have an 85% likelihood of developing diabetes (stage 3) within five years.

Investigators tested teplizumab for the prevention or delay of onset clinical T1D in high-risk patients through a randomized, placebo-controlled, double-blind trial involving 76 participants. The results have also been presented to delegates at the American Diabetes Association meeting, which has been taking place in San Francisco from Friday, June 7, to Tuesday, June 11. The effects of the drug were greatest in the first year after it was given, said the study published online in The New England Journal of Medicine.

In an accompanying editorial, Clifford Rosen, MD, of the Maine Medical Center Research Institute in Scarborough, and Julie Ingelfinger, MD, of Massachusetts General Hospital in Boston called the findings "striking", but cautioned that these "results should not be taken to imply that immune modulation constitutes a potential curative approach". "And I think if you were to ask the families of any of the participants in this trial, or even the families of people with diabetes, they would reiterate this point".

An important caveat, they said, is that these findings shouldn't be interpreted as a cure.

The trial was conducted by Type 1 Diabetes Trialnet, which researches strategies to delay or prevent T1D. Or what if this drug was used with another?

The study was conducted by Type 1 Diabetes TrialNet (NCT00097292), a collaboration funded by the National Institutes of Health, primarily through the Special Statutory Funding Program for Type 1 Diabetes. Most participants had a sibling with type 1 diabetes.

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