Type 1 Diabetes Drug Proves Effective in Clinical Trial

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Type 1 Diabetes Drug Proves Effective in Clinical Trial


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Old 08-08-2013, 13:55   #1
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Type 1 Diabetes Drug Proves Effective in Clinical Trial | ucsf.edu

Drug Developed by UCSF Researcher Shows Promise for Blocking Advance of Disease in Earliest Stages

An experimental drug designed to block the advance of type 1 diabetes in its earliest stages has proven strikingly effective over two years in about half of the patients who participated in the phase 2 clinical trial.

Patients who benefited most were those who still had relatively good control of their blood sugar levels and only a moderate need for insulin injections when the trial began. With the experimental drug, teplizumab, they were able to maintain their level of insulin production for the full two years – longer than with most other drugs tested against the disease.

Results are published online in the journal Diabetes, and will appear in the November issue of the print edition.

The treatment did not benefit all patients. Some lost half or more of their ability to produce insulin – a drop similar to many of the controls not receiving the drug. Reasons for the different responses are unclear, but likely involve differences in the metabolic condition of the patients and in the severity of their disease at the trial’s start, the researchers said.

“The benefits of treatment among the patients who still had moderately healthy insulin production suggests that the sooner we can detect the pre-diabetes condition and get this kind of drug onboard, the more people we can protect from the progressive damage caused by an autoimmune attack,” said Jeffrey Bluestone, PhD, co-leader of the research and A.W. and Mary Clausen Distinguished Professor at UC San Francisco, who collaborated in developing the drug.

The clinical trial was led by Kevan Herold, MD, PhD, a professor of immunobiology and deputy director for translational science at Yale University. He and Bluestone have collaborated on four previous clinical trials of the experimental drug.

“We are very excited by the efficacy of the drug,” Herold said. “Some of our patients and families have described a real impact on their diabetes.”

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Old 08-08-2013, 15:41   #2
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"Possible Side Effects

Nearly all (99%) patients in both the teplizumab and placebo groups experienced some type of side effect. The most common side effect among people on teplizumab was a transient mild to moderate rash (53% vs. 20% on placebo).

The rate of serious side effects was also similar among the groups, with 10% of patients on teplizumab and 9% on placebo affected.

A total of 4% of patients in the teplizumab groups had to stop taking the drug due to a low white blood cell count or an increase in liver enzymes vs. 2% in the placebo group.

In an editorial accompanying the study, Jean-Francois Bach, MD, of University Paris Descartes in France, writes that while the findings are encouraging, they were based mainly on unplanned analyses done after the study was completed. There is a need for further studies, perhaps using slightly higher doses of teplizumab sooner after diagnosis, he says.

"Ideally, type 1 diabetes should be regarded as a medical emergency and treatment with teplizumab could be started within a few days after diagnosis, as compared with several weeks or months as is done now," Bach writes."

From, Drug May Treat Newly Diagnosed Type 1 Diabetes

UGH. May yet be worth it, however ...

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Old 08-08-2013, 22:25   #3
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Quote:
Originally Posted by foxl View Post
UGH. May yet be worth it, however ...
If those numbers hold, seems more than worth it to me, and I'm not even a type I. The relative increase of side effects was large but the absolute risk is still pretty insignificant from what I can see. I'd be more concerned with long term liver health than anything, and I'd be interested in seeing the higher dose studies.

Those will probably take another thirty years to complete.

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