Diabetes: Study using Otelixizumab for Type I Diabetes

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Diabetes: Study using Otelixizumab for Type I Diabetes




Guest:  Dr. Jeremy Soule - Medicine/Endocrinology, Diabetes & Medical Genetics

Host:  Dr. Linda Austin – Psychiatry


Dr. Linda Austin:  Dr. Jeremy Soule is Assistant Professor in the Department of Medicine at MUSC and works in Endocrinology, which is a field that is all about hormones and the endocrine system, including diabetes.  You are starting a very interesting new study about an agent that I find kind of hard to pronounce, Otelixizumab.  Tell us what that agent does.  And maybe, to understand it, you could give us an overview, first, of what diabetes is and what part of the body is at fault when a person develops diabetes.


Dr. Jeremy Soule:  Okay.  Well, there are two basic types of diabetes, type 1 and type 2.  Type 1 diabetes is the type of diabetes that we have classically thought of as occurring in younger people and children.  In that situation, what happens is, the body loses its ability to make insulin, and insulin is the hormone that is important for controlling glucose levels.


Dr. Linda Austin:  Sugar levels in the blood, right?


Dr. Jeremy Soule:  Yes.  Insulin is made by an organ called the pancreas.  And in type 1 diabetes, we think the immune system begins to attack the cells in the pancreas that make insulin.  These cells that make insulin are called beta cells. 


The idea behind this clinical trial that we’re doing is we’re seeing if this medication, Otelixizumab, is capable of turning off or turning down that immune system attack on the pancreas, the attack on the cells that are making the insulin.


Dr. Linda Austin:  Now, that would be an autoimmune disorder, right?  The immune system is when the body produces molecules or cells to attack normally foreign germs, microbes, bacteria, viruses.  In this case, the body is actually attacking itself.


Dr. Jeremy Soule:  Right.  So, in type 1 diabetes, the immune system is attacking itself and it’s attacking the beta cells that make insulin.  And, therefore, the body’s ability to make insulin is decreased and ultimately stops altogether.


Dr. Linda Austin:  Let’s talk some more about this agent, because I’m sure that anybody who might be interested in participating in this trial would really want to understand that better.  Otelixizumab has been tried in other illnesses, correct?


Dr. Jeremy Soule:  Yeah.  There are clinical trials going on in other autoimmune diseases such as psoriasis, for instance.  This agent isn’t really targeting the pancreas per se.  But what it is targeting are the cells that are attacking the pancreas.  These cells are called T-cells, and they’re one of the types of cells in the immune system that normally defend the body from outside foreign agents.  But, in type 1 diabetes, like in other autoimmune diseases, the immune system is attacking the person’s body itself rather than a foreign substance.


Dr. Linda Austin:  Has this agent been around long enough and been tried on enough people that scientists are pretty confident that it’s a safe medication, or is that one of the questions in the study?


Dr. Jeremy Soule:  Well, that’s definitely one of the questions we are trying to answer in the study.  The compound has been studied earlier and, actually, the results have been published in the New England Journal of Medicine.  And, what the compound was seen to do was to decrease the dependence on insulin and the preservation of the pancreas’s ability to make insulin on its own in patients with new onset diabetes. 


So, this is a phase III trial.  It’s looking at the effect of a standard dose of the agent given intravenously, looking at the effect of that in terms of decreasing the immune system’s attack on the pancreas and, thereby, hopefully, decreasing the need for insulin in the future.


Dr. Linda Austin:  I think everybody knows that insulin is the treatment for diabetes.  Why might a person be interested in participating in this trial?  What might Otelixizumab offer someone?


Dr. Jeremy Soule:  Okay.  Well, there was a very important study done back in the 1990s called the Diabetes Control and Complications Trial (DCCT).  This was a trial looking at intensive control of diabetes in people who had fairly new onset diabetes.  In that study, it was possible to look at whether these patients still had an ability to produce a little bit of insulin or not.  If you looked at the patients who were still able to produce a little bit of insulin, they actually did better.  They had a tendency toward fewer problems with low blood sugars, or hypoglycemia, and they also did better in terms of having a slower onset of complications to diabetes.  We worry about trouble with the eyes and the kidneys, and the nerves.  And, particularly, with these types of complications, the patients who were able to make even just a little bit of insulin on their own seemed to do better. 


So, what we would hope is that this agent would allow us to set up a similar situation in patients with new onset type 1 diabetes.  We would allow them to continue to have some production of insulin by their own pancreas.  And we would hope that that corresponds to other types of benefits that we’re seeing in the DCCT. 


Dr. Linda Austin:  That makes a great deal of sense.  Tell us about what kind of patient you are looking for.  You mentioned new onset diabetes.  How recent must the onset have been to participate?


Dr. Jeremy Soule:  We are looking for adult patients.  These are patients between 18 and 35 years of age.  And they have to have been diagnosed with diabetes within the last 90 days.  In fact, we need to start the infusion within that 90-day time period.  So, it would be very important to be able to have a conversation with potential subjects right after their initial diagnosis of diabetes.


Dr. Linda Austin:  Is this trial being done in other parts of the country as well?  I’m thinking this podcast might be listened to by people, really, all over the world.


Dr. Jeremy Soule:  It’s a multi-center trial.  It’s being done by a company called Tolerx.  There are many sites participating both in the Unites States and abroad.


Dr. Linda Austin:  So, we need to spell this drug.


Dr. Jeremy Soule:  Sure.


Dr. Linda Austin:  If people wanted more information, how would they get?  Where could they go online?


Dr. Jeremy Soule:  The company that’s sponsoring this trial is Tolerx, T, o, l, e, r, x.  The drug itself, Otelixizumab, is spelled, O, t, e, l, i, x, i, z, u, m, a, b.


Dr. Linda Austin:  I want to hear some more about the trial.  Let’s imagine that somebody listening to this, either they or someone they know has just been diagnosed with diabetes, what would their next step be?


Dr. Jeremy Soule:  Well, their next step would be to contact us.  Contact information will be posted on the website.  After you contacted us, some initial laboratory screening would be done to confirm the diagnosis of type 1 diabetes.  Then you would also undergo several other tests looking at the body’s ability to still produce some insulin.  If you qualified for the study, the next step would be an infusion with the drug.  And that, actually, is an eight-day infusion where you’d come into the hospital for a two-hour infusion for eight days in a row.


Dr. Linda Austin:  So, you would stay, what, in a hotel room or something, if you were coming to Charleston from outside?


Dr. Jeremy Soule:  If you were coming to Charleston from outside the local area, we could look into arranging hotel accommodations.  If you’re here locally, in Charleston, it would involve spending half a day here at our center.


Dr. Linda Austin:  And, tell us, for people who’ve never had an IV, what an infusion is like?  What do you mean when you say that?


Dr. Jeremy Soule:  So, an infusion is the administration of a fluid through the vein.  It’s what you would commonly see done in the emergency room where somebody was getting saline or water to help deal with dehydration.  What’s involved is placing a very small needle in the vein, in the arm, the same vein that’s often used to draw blood from for tests, and attaching the medication to the needle that’s in the arm.  And, the infusion takes place, again, daily over the course of eight days.  And the whole process would take about half a day to administer.


Dr. Linda Austin:  And then, after those eight days are over, is that the end of the patient’s, what the patient actually has to do?


Dr. Jeremy Soule:  So, after the eight-day infusion, close follow-up is still necessary.  And we would have a series of visits that would decrease in frequency over time.  But initially, we’d see the patient on a weekly basis, and then gradually spread the visits out such that we’d see the patient at least every few months.  Follow-up will be long-term, at least for two years, with the idea that you’ll be getting close follow-up to make sure that the medication has been well tolerated, and to give us a chance to assess whether it’s been effective or not.


Dr. Linda Austin:  But, the patient doesn’t take any other medication beyond that, doesn’t take tablets or anything after those eight days?  They would get their regular care?


Dr. Jeremy Soule:  Right.  They would continue their regular care.  They would continue to use insulin as needed under the care of their endocrinologist or treating physician.


Dr. Linda Austin:  Dr. Soule, since this medication has been used for other patients in the past, you must have an idea what the side effects are.  What are some of the side effects?


Dr. Jeremy Soule:  Generally, it’s been fairly well tolerated.  Occasionally there are problems with headaches.  We’d be happy to talk to any interested patients about this.


Dr. Linda Austin:  And, of course, as with all of our studies, there is a review board that has looked over the protocol, and it is scrupulously monitored so these patients really get the best of care, and you’re watching them very carefully.


Dr. Jeremy Soule:  Yes.  We are.


Dr. Linda Austin:  It is certainly a pain in the neck to get an infusion for three hours a day for eight days.  But when you think that this is a lifelong illness that, over the course of many years, can really take a toll, I’d do it if I were in that situation.  It sounds like it’s a very important opportunity for patients to get a drug that may make a real difference in the quality of their lives.


Dr. Jeremy Soule:  Yeah.  We’re really hoping it does, and I share your enthusiasm.


Dr. Linda Austin:  Dr. Soule, thank you so much for talking with us today.


Dr. Jeremy Soule:  Thank you very much.


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