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Update on New Type 1 Diabetes Clinical Trials

July 20, 2011

At the recent American Diabetes Association 71st Scientific Sessions in San Diego the results of several clinical trials focused on finding a cure for type 1 diabetes were announced.

Most of these trials tested drugs administered to people with type 1 diabetes to curb the autoimmune attack on the beta cells. If scientists can determine a way to control the autoimmune response involved in type 1, along with methods of either regenerating or replacing the lost beta cells, the combination of these areas of research could result in a cure for type 1.

Two of the clinical trials showed efficacy and met their primary endpoints (that is, they satisfied pre-determined parameters of success) and another, while not a success by clinical standards, did reveal some clues as to how scientists can continue to refine these drug therapies to be more effective and impactful for people with type 1.

The first trial, known as the AbATE trial, tested an anti-CD3 drug therapy (known as teplizumab). The Phase II trial was successful in slowing the progression of type 1 diabetes in people with newly diagnosed disease. Individuals in the teplizumab arm received two separate 14-day courses of the drug, once at the beginning of the study and once 12 months later. Trial participants had higher levels of C-peptide (indicating the presence of naturally produced insulin in the body) at 24 months after treatment and lower insulin needs at 12 and 18 months after treatment compared to a control group that received a placebo drug.

A second trial, also Phase II (testing a drug called CTLA4-Ig or Abatacept) also showed treated participants as having higher levels of C-peptide than participants who had received a placebo at two years after treatment, as well as lower A1C levels, indicating better control of blood sugar levels.

A third trial, known as the Protégé trial, showed mixed results. While the Phase III Protégé trial, also conducted with the anti-CD3 drug teplizumab, did not meet its pre-determined endpoints when the data is viewed as a whole, certain sub-groups of participants responded well to the drug therapy. Children between the ages of 8 and 11 years old, participants who had been diagnosed within six weeks of receiving the first dosage, participants who received longer, higher-dose regimens of the drug, and participants in the United States had evidence of preserved beta cell function at 12 months after treatment was begun.

JDRF will provide a more detailed report on all results coming out of the Scientific Sessions in an upcoming issue of Countdown.

If you’d like to find out more about clinical trials or participate in one, please visit the JDRF Type 1 Diabetes Clinical Trials Connection.

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To learn more about the JDRF Dallas chapter, visit our JDRF Dallas website!

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