What
is LADA?
Diabetes
or a high blood sugar results from a lack of insulin production or
a lack of insulin action in the body’s tissues. We know that
type 1 diabetes is a condition in which the immune system reacts against
the insulin-producing beta cells in the pancreas, a process known
as autoimmune destruction. Autoimmune destruction of the beta cells
eventually results in a lack of insulin. Type 2 diabetes is a different
process whereby initially insulin production in the beta cells is
sufficient but the insulin does not work as well at distant sites
in the body due to insulin resistance. It is easy to see that in extremes
of either case diabetes can occur. One can also see that a combination
of both processes could also lead to diabetes.
In
the last ten years it has become evident from research that there
are many people who have both type 1 and 2 diabetes processes. The
largest study to show this was the United Kingdom Prospective Diabetes
Study published in 1997. They identified that 10% of adults (age 25
– 65) with presumed type 2 diabetes had glutamic acid decarboxylase
antibody (GAD Ab), a highly specific marker of autoimmune destruction
of the beta cells, ie. evidence of a type 1 diabetes process. Many
other studies have identified a similar number of people, approximately
1 in 10 adults who have GAD Ab and are presumed to have type 2 diabetes.
This condition is also known as latent autoimmune diabetes in adults
(LADA). These people are different from children with type 1 diabetes
because they clinically present as someone with type 2 diabetes, they
do not require insulin for at least 6 to 12 months after diagnosis
of their diabetes and may be overweight.
Why
is it important to identify LADA in adults?
Because
adults with diabetes and GAD Ab :
have a high probability of requiring insulin injections within 6 years
of diagnosis
have significant insulin
deficiency and may be at risk of future ketoacidosis
may also be eligible
to participate in INIT III, an immunoprevention trial that
we are conducting.
What
is INIT III?
The INIT
III (Intranasal Insulin 3) trial aims to determine whether treatment
with intranasal insulin can preserve beta-cell function by inducing
a protective immune response and therefore avoid the need for insulin
injections.
Type
1 or insulin-dependent diabetes occurs when the body’s immune
system reacts against and damages the beta cells in the pancreas that
make the hormone insulin. Without enough insulin, the level of sugar
(glucose) in the blood increases, causing symptoms. Insulin then needs
to be taken by injection every day.
When
type 1 diabetes occurs in adults (LADA) it usually has a slower onset.
However, it is still likely that it will require treatment with insulin
injections within several years. Many patients with LADA are initially
diagnosed as having type 2 diabetes, the more common form of diabetes
in adults. A blood test for antibodies against components of the insulin-producing
beta cells in the pancreas is used to confirm the diagnosis of LADA.
Research
on mice that develop type 1 diabetes shows that treatment with intranasal
or inhaled insulin causes protective changes in the immune system
that prevent damage to the insulin-producing beta cells. In a recently
completed trial in children and young adults at risk for type 1 diabetes,
insulin given via a nasal spray for six months was found to be safe
and to cause the same immune changes as in the mice that are protected
from getting diabetes. Therefore, it is possible that intranasal or
inhaled insulin in humans, as in the mice, prevent the disease process
from progressing and the need for insulin injections.
What
is the aim of the trial?
The
trial is designed to determine the effect of intranasal insulin on
the immune process which damages the beta cells of the pancreas and
on the ability of the beta cells to make insulin. In particular, it
will determine if this treatment can delay or prevent the need for
insulin injections in people with LADA.
What
is involved?
| The
duration of the trial is 2 years. The trial is placebo-controlled,
which means that participants would be assigned randomly to one
of two groups. One group would receive their normal treatment
for diabetes and an intranasal insulin nasal spray, and the other
group would receive normal treatment with a 'placebo' nasal spray,
that has no effect. The reason for this design is to measure the
difference between people who are receiving the new treatment,
and people who are simply receiving standard treatment for diabetes.
The nasal spray treatment would be given daily for 10 days, then
twice a week for the rest of the trial, and would be done at home
by participants. |
 |
Who
can participate?
If
you have type 2 diabetes which has been diagnosed in the last 12 months,
and are not receiving insulin injections, then you may be eligible
to participate in this trial. Contact Spiros
Fourlanos or Chris
Perry for further information.
Return
to Clinical Trials Page
Return
to INIT III Page
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LADA Page
