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
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
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
Dr. Linda Austin: So, you would stay, what, in a hotel room or
something, if you were coming to Charleston
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
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
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.
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
Dr. Jeremy Soule: Thank you very much.
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